Acute Myeloid Leukemia (AML)Phase 2PacritinibNCT02532010
Pacritinib Combined With Decitabine or Cytarabine in Older Patients With AML
A Phase 2 study testing Pacritinib, Decitabine and Cytarabine in people with Acute Myeloid Leukemia (AML), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to see if a medicine called pacritinib is both safe and effective as a study intervention for patients with AML in combination with either decitabine or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Pacritinib, Decitabine and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2015to 24 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient has unequivocal pathologic diagnosis of AML (≥ 20% blasts in the bone marrow based on World Health Organization (WHO) criteria), excluding acute promyelocytic leukemia t(15;17)(q22;q12); Promyelocytic leukemia gene (PML)- retinoic acid receptor alpha (RARA)
- Age ≥ 65 years old
- No prior treatment for AML except:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiotherapy (RT) for Central Nervous System (CNS) leukostasis (one dose only)
Show all 15Show fewer
- Growth factor/cytokine support
- AML patients with therapy-related myeloid neoplasms are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for ≥ 6 months. Hydroxyurea may be used at the investigator's discretion up to the first 28 days on Cycle 1 to maintain WBC <30,000/µl.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Subjects must have adequate hepatic and renal function
- Female subject of child-bearing potential and male subjects with female partners of reproductive potential must use acceptable contraceptive methods
- Able to understand and to provide written informed consent
- Able to comply with all study procedures during the study including all visits and tests
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Patient must sign an informed consent form (ICF)
Who cannot join
- Prior treatment with decitabine
- Prior treatment with cytarabine
- Prior treatment with pacritinib
- Presence of serious illness, medical condition, or other medical history, involving the heart, kidney, liver, or other organ system, including abnormal laboratory parameters, which, in the opinion of the Investigator, would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
- Active, uncontrolled, clinically significant infection(s)
- Have other active malignancies (excluding other myeloid hematologic malignancies) or other malignancies within 12 months before enrollment, except curatively treated non-melanoma skin cancer, cervical intraepithelial neoplasia, organ-confined or treated non-metastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
Show all 15Show fewer
- Are receiving any other investigational therapy or protocol-prohibited therapy
- Any prior or co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the subject's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures
- Any gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication
- Inflammatory or chronic functional bowel disorder, such as Crohn's disease, inflammatory bowel disease, chronic diarrhea
- Clinically symptomatic and uncontrolled cardiovascular disease
- History of any of the following within 6 months: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure
- New York Heart Association Class III or IV congestive heart failure
- Patients with National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) grade 2 cardiac arrhythmias may be considered for inclusion with the approval of the investigator if the arrhythmias are stable, asymptomatic and unlikely to affect patient safety. Patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade 3, corrected QT interval (QTc) prolongation >450 ms by Fridericia method, or other factors that increase the risk for QT prolongation (eg, heart failure, hypokalemia [defined as serum potassium < 3.0 milliequivalent (mEq/L) that is persistent and refractory to correction], or family history of long QT interval syndrome).
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Induction Therapy With Pacritinib Combined With Decitabine or Cytarabine in Older Patients With Acute Myeloid Leukemia (AML)
The purpose of this study is to see if a medicine called pacritinib is both safe and effective as a study intervention for patients with AML in combination with either decitabine or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are used in treatment of AML. Pacritinib is being tested in clinical trials and has not been submitted to the U.S. Food and Drug Administration (FDA) for approval for any indications. Pacritinib is a drug that is designed to slow down the growth of leukemic cells.
Read the detailed description
This is a single-center, open label, two-arm phase II study of clinical activity of pacritinib in older patients newly diagnosed with AML combined with either decitabine or cytarabine. In this study, approximately 61 patients will be enrolled at the Weill Cornell Medical College. Arm A consists of pacritinib and decitabine and will enroll 31 subjects, and Arm B consists of pacritinib and cytarabine and will enroll 30 subjects. Arm A and B will enroll sequentially. The dose of pacritinib will be 200mg twice a day continuously.
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Treatment may be given on an outpatient basis if hospitalization is not otherwise required. Every effort should be made to give decitabine or cytarabine consecutively for 10 days; however if interruption is needed, discussion will be held with the medical monitor and the investigator.
The first day of a cycle will be defined as the day on which decitabine or cytarabine is started. First treatment will take place on Cycle 1, day 1. Hydroxyurea may be used at the investigator's discretion for the first 28 days on Cycle 1 to maintain white blood cell count (WBC) <30,000/µl. Bone marrow biopsy and aspiration will be performed between days 22-56 of each cycle and the subsequent treatment cycle will be started between days 22-56, at the investigator's discretion. Ideally, cycles will be administered at 28-day intervals, but treatment delays of decitabine or cytarabine up to 56 days will be permitted to allow resolution of non-hematologic and non-disease-related hematologic toxicities. Granulocyte-stimulating cytokine support will be permitted at the investigator's discretion in the event of neutropenic fever/sepsis as per American Society of Clinical Oncology (ASCO) guidelines.16 Bone marrow aspiration and biopsy will be performed within 5 days of peripheral blood count recovery to an absolute neutrophil count (ANC) ≥ 1000/µL and platelets ≥ 100,000/µL without transfusions, or day 28 whichever comes first. If the peripheral blood absolute blast count is ≥ 5000/µL on day 21 of the first cycle, the second cycle may be administered immediately after bone marrow aspiration and biopsy.
Each arm will enroll in a Simon's two-stage design as described in Section 8. In Arm A, 16 subjects will initially be entered into the study, and if 6 or fewer respond, then Arm A will be terminated early and study will proceed to Arm B. In Arm B, 15 subjects will initially be entered into the study, and if 2 or fewer respond, the study will be terminated early.
Duration of study therapy Patients will receive a minimum of 4 cycles of treatment unless there is evidence of unacceptable regimen-related toxicity or unequivocal disease progression for which the investigator is specifically recommending alternative therapy. Pacritinib will continue throughout the study.
Arm A:
Patients who achieve Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), or complete remission with incomplete blood count recovery (CRi) will receive subsequent cycles of decitabine on a monthly basis with decitabine 20mg/m2 IV daily for 5 days with pacritinib. Patients who do not achieve complete remission, but who are responding to treatment (partial response, hematologic response, or clinical benefit as determined by the investigator) will receive four 10-day cycles of decitabine with pacritinib as indicated in the study design, followed by monthly maintenance cycles of decitabine 20mg/m2 IV daily for 5 days + daily pacritinib. The maintenance cycles will continue indefinitely until relapse or toxicity. Patients may be taken off study for allogeneic stem cell transplantation at the discretion of the investigator.
Arm B:
Patients will continue cytarabine 20mg subcutaneous twice daily for 10 days combined with pacritinib for up to 4 cycles to achieve CR, CRp, or CRi. Those patients who achieve CR, CRp, or CRi after 4 cycles may continue to receive monthly maintenance of cytarabine 20mg subcutaneous twice daily for 10 days with pacritinib. The maintenance cycles will continue indefinitely until relapse or toxicity. Patients may be taken off study for allogeneic stem cell transplantation at the discretion of the investigator.
Screening (Study Day -14 to Day 1) Initiate and complete screening activities within 14 days before Cycle 1, Day 1 treatment.
Treatment (Cycle 1, Day 1 through End-of-Treatment Visit) This period begins on the day the patient first receives treatment and ends at the End-of-Treatment Visit.
Follow-up After completion of the End-of-Treatment Visit, all patients are followed up for 30 days and followed every three months for survival and disease status.
Clinical Study Endpoints The Primary objective of the study is to evaluate the safety and efficacy of pacritinib combined with decitabine or cytarabine in newly diagnosed older (≥65 years old) patients with AML. The primary endpoint of this study will be complete remission according to the International Working Group (IWG) criteria.
The following secondary endpoints will be evaluated:
- Overall Survival (OS)
- Overall remission (OS) rate, defined as CR + CRp + Cri + Partial Remission (PR) based on IWG response criteria
- Relapse-free Survival (RFS)
- Event-free Survival (EFS)
- Time to Complete Response (TTCR)
- Remission Duration
DISCUSSION OF STUDY DESIGN
Prognosis for older patients with AML is poor, with median survival of only 9-12 months. Older patients are often not candidates for intensive chemotherapy or allogeneic stem cell transplantation. Decitabine and low-dose cytarabine are frequently used for upfront treatment of older AML patients, however CR rates are 40-50% with decitabine and 18% with cytarabine. Pacritinib is a potent tyrosine kinase inhibitor of FLT3 and Janus Kinase 3 (JAK3) tyrosine kinases. The objective of the proposed clinical trial is to evaluate the efficacy, safety, and feasibility of pacritinib combined with decitabine or cytarabine in newly diagnosed older AML patients. The primary endpoint will be increase in complete remission.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Pacritinib, Decitabine, Cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
Also called SB1518
Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nanomolar (nM)and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit Janus kinase 1 (JAK1).
DecitabineDrug
Also called Dacogen
Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
CytarabineDrug
Also called Cytosar-U, Tarabine PFS, Cytosar
Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pacritinib and Decitabine | Active comparator | Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily. Receives: Drug: Pacritinib; Drug: Decitabine |
| Arm B: Pacritinib and Cytarabine | Active comparator | Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily. Receives: Drug: Pacritinib; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
Complete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of <5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.
Measured: 6 months
Secondary outcomes (6)
Overall Survival
Survival following treatment to the date of death
Measured: 2 years
Overall Remission Rate
Overall remission rate is defined as number of subjects with complete remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR) according to the IWG criteria. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)), PR is defined as relevant in the setting of phase I and II clinical trials only; all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pretreatment bone marrow blast percentage by at least 50 percent.
Measured: 6 months
Relapse-free Survival
Time from complete remission documentation to either AML relapse or death from any cause.
Measured: From date of complete remission until either AML relapse or death from any cause, whichever came first, assessed throughout the study period up to 2 years
Event-free Survival
Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause
Measured: Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause, assessed throughout the study period up to 2 years
Time to Complete Response
Time from entry on study until documentation of complete remission (CR)
Measured: From entry on study until complete remission, assessed throughout the study period up to 2 years
Remission Duration
Time from CR documentation to AML relapse
Measured: time from complete remission to AML relapse, assessed throughout the study period up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study start15 Jun 2015
- Primary completion9 Feb 2016
- Study completion24 Oct 2017
Why it stopped: The study was put on clinical hold by the sponsor since Feb 9th 2016, and was later decided not to re-open due to financial constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SangMin Lee, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532010
- Sponsor's protocol ID
- 1403014921
- Acronym
- Pacritinib
- Status last verified
- Jun 2018
- First submitted
- 6 Aug 2015
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: data will be shared with the sponsor
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Therapy With Pacritinib Combined With Decitabine or Cytarabine in Older Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT02532010
- Acronym / sponsor ID
- Pacritinib / 1403014921
- Conditions
- Acute Myeloid Leukemia (AML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was put on clinical hold by the sponsor since Feb 9th 2016, and was later decided not to re-open due to financial constraints.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 9 Feb 2016 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if a medicine called pacritinib is both safe and effective as a study intervention for patients with AML in combination with either decitabine or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are used in treatment of AML. Pacritinib is being tested in clinical trials and has not been submitted to the U.S. Food and Drug Administration (FDA) for approval for any indications. Pacritinib is a drug that is designed to slow down the growth of leukemic cells.
Detailed description
This is a single-center, open label, two-arm phase II study of clinical activity of pacritinib in older patients newly diagnosed with AML combined with either decitabine or cytarabine. In this study, approximately 61 patients will be enrolled at the Weill Cornell Medical College. Arm A consists of pacritinib and decitabine and will enroll 31 subjects, and Arm B consists of pacritinib and cytarabine and will enroll 30 subjects. Arm A and B will enroll sequentially. The dose of pacritinib will be 200mg twice a day continuously.
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Treatment may be given on an outpatient basis if hospitalization is not otherwise required. Every effort should be made to give decitabine or cytarabine consecutively for 10 days; however if interruption is needed, discussion will be held with the medical monitor and the investigator.
The first day of a cycle will be defined as the day on which decitabine or cytarabine is started. First treatment will take place on Cycle 1, day 1. Hydroxyurea may be used at the investigator's discretion for the first 28 days on Cycle 1 to maintain white blood cell count (WBC) <30,000/µl. Bone marrow biopsy and aspiration will be performed between days 22-56 of each cycle and the subsequent treatment cycle will be started between days 22-56, at the investigator's discretion. Ideally, cycles will be administered at 28-day intervals, but treatment delays of decitabine or cytarabine up to 56 days will be permitted to allow resolution of non-hematologic and non-disease-related hematologic toxicities. Granulocyte-stimulating cytokine support will be permitted at the investigator's discretion in the event of neutropenic fever/sepsis as per American Society of Clinical Oncology (ASCO) guidelines.16 Bone marrow aspiration and biopsy will be performed within 5 days of peripheral blood count recovery to an absolute neutrophil count (ANC) ≥ 1000/µL and platelets ≥ 100,000/µL without transfusions, or day 28 whichever comes first. If the peripheral blood absolute blast count is ≥ 5000/µL on day 21 of the first cycle, the second cycle may be administered immediately after bone marrow aspiration and biopsy.
Each arm will enroll in a Simon's two-stage design as described in Section 8. In Arm A, 16 subjects will initially be entered into the study, and if 6 or fewer respond, then Arm A will be terminated early and study will proceed to Arm B. In Arm B, 15 subjects will initially be entered into the study, and if 2 or fewer respond, the study will be terminated early.
Duration of study therapy Patients will receive a minimum of 4 cycles of treatment unless there is evidence of unacceptable regimen-related toxicity or unequivocal disease progression for which the investigator is specifically recommending alternative therapy. Pacritinib will continue throughout the study.
Arm A:
Patients who achieve Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), or complete remission with incomplete blood count recovery (CRi) will receive subsequent cycles of decitabine on a monthly basis with decitabine 20mg/m2 IV daily for 5 days with pacritinib. Patients who do not achieve complete remission, but who are responding to treatment (partial response, hematologic response, or clinical benefit as determined by the investigator) will receive four 10-day cycles of decitabine with pacritinib as indicated in the study design, followed by monthly maintenance cycles of decitabine 20mg/m2 IV daily for 5 days + daily pacritinib. The maintenance cycles will continue indefinitely until relapse or toxicity. Patients may be taken off study for allogeneic stem cell transplantation at the discretion of the investigator.
Arm B:
Patients will continue cytarabine 20mg subcutaneous twice daily for 10 days combined with pacritinib for up to 4 cycles to achieve CR, CRp, or CRi. Those patients who achieve CR, CRp, or CRi after 4 cycles may continue to receive monthly maintenance of cytarabine 20mg subcutaneous twice daily for 10 days with pacritinib. The maintenance cycles will continue indefinitely until relapse or toxicity. Patients may be taken off study for allogeneic stem cell transplantation at the discretion of the investigator.
Screening (Study Day -14 to Day 1) Initiate and complete screening activities within 14 days before Cycle 1, Day 1 treatment.
Treatment (Cycle 1, Day 1 through End-of-Treatment Visit) This period begins on the day the patient first receives treatment and ends at the End-of-Treatment Visit.
Follow-up After completion of the End-of-Treatment Visit, all patients are followed up for 30 days and followed every three months for survival and disease status.
Clinical Study Endpoints The Primary objective of the study is to evaluate the safety and efficacy of pacritinib combined with decitabine or cytarabine in newly diagnosed older (≥65 years old) patients with AML. The primary endpoint of this study will be complete remission according to the International Working Group (IWG) criteria.
The following secondary endpoints will be evaluated:
- Overall Survival (OS)
- Overall remission (OS) rate, defined as CR + CRp + Cri + Partial Remission (PR) based on IWG response criteria
- Relapse-free Survival (RFS)
- Event-free Survival (EFS)
- Time to Complete Response (TTCR)
- Remission Duration
DISCUSSION OF STUDY DESIGN
Prognosis for older patients with AML is poor, with median survival of only 9-12 months. Older patients are often not candidates for intensive chemotherapy or allogeneic stem cell transplantation. Decitabine and low-dose cytarabine are frequently used for upfront treatment of older AML patients, however CR rates are 40-50% with decitabine and 18% with cytarabine. Pacritinib is a potent tyrosine kinase inhibitor of FLT3 and Janus Kinase 3 (JAK3) tyrosine kinases. The objective of the proposed clinical trial is to evaluate the efficacy, safety, and feasibility of pacritinib combined with decitabine or cytarabine in newly diagnosed older AML patients. The primary endpoint will be increase in complete remission.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Pacritinib and Decitabine | Active comparator | Drug: Pacritinib, Drug: DecitabineArm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily. |
| Arm B: Pacritinib and Cytarabine | Active comparator | Drug: Pacritinib, Drug: CytarabineArm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Patient has unequivocal pathologic diagnosis of AML (≥ 20% blasts in the bone marrow based on World Health Organization (WHO) criteria), excluding acute promyelocytic leukemia t(15;17)(q22;q12); Promyelocytic leukemia gene (PML)- retinoic acid receptor alpha (RARA)
- Age ≥ 65 years old
- No prior treatment for AML except:
- AML patients with therapy-related myeloid neoplasms are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for ≥ 6 months. Hydroxyurea may be used at the investigator's discretion up to the first 28 days on Cycle 1 to maintain WBC <30,000/µl.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (15 listed)
- Prior treatment with decitabine
- Prior treatment with cytarabine
- Prior treatment with pacritinib
- Presence of serious illness, medical condition, or other medical history, involving the heart, kidney, liver, or other organ system, including abnormal laboratory parameters, which, in the opinion of the Investigator, would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
- Active, uncontrolled, clinically significant infection(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacritinibAlso: SB1518Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nanomolar (nM)and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit Janus kinase 1 (JAK1). | Drug | Arm A: Pacritinib and Decitabine, Arm B: Pacritinib and Cytarabine |
| DecitabineAlso: DacogenCommercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily. | Drug | Arm A: Pacritinib and Decitabine |
| CytarabineAlso: Cytosar-U, Tarabine PFS, CytosarCommercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily. | Drug | Arm B: Pacritinib and Cytarabine |
Primary outcome
Complete Remission Rate
Time frame: 6 months
Complete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of <5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.
6 secondary outcomes
Overall Survival
Time frame: 2 years
Overall Remission Rate
Time frame: 6 months
Relapse-free Survival
Time frame: From date of complete remission until either AML relapse or death from any cause, whichever came first, assessed throughout the study period up to 2 years
Event-free Survival
Time frame: Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause, assessed throughout the study period up to 2 years
Time to Complete Response
Time frame: From entry on study until complete remission, assessed throughout the study period up to 2 years
Remission Duration
Time frame: time from complete remission to AML relapse, assessed throughout the study period up to 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. data will be shared with the sponsor
Related trials for Acute Myeloid Leukemia (AML)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SangMin Lee, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pacritinib, Decitabine and Cytarabine in people with Acute Myeloid Leukemia (AML), run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.