Recurrent Adult Acute Myeloid LeukemiaPhase 1NCT02323607
Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations
A Phase 1 study testing Pacritinib, Cytarabine and Daunorubicin Hydrochloride in people with Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, run by Bhavana Bhatnagar at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of pacritinib when given together with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
- What is being tested?
- Pacritinib, Cytarabine and Daunorubicin Hydrochloride
- Type of treatment
- Pill or oral medicine, 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
- 12 Jan 2016to 12 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML and the presence of FLT3 mutation
- Patients with secondary AML or therapy related disease (t-AML) are eligible
- If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Total bilirubin < 2.0mg/dL unless due to Gilbert's disease
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
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- Creatinine (Cr) clearance > 50 mL/min by Cockcroft-Gault calculation
- New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
- Cardiac ejection fraction >= 50% for Arm A, >= 40% for Arm B
- Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
- Ability to understand and willingness to sign the written informed consent document
- Human immunodeficiency virus (HIV) infection without history of acquired immune deficiency syndrome (AIDS) and sufficiently high cluster of differentiation (CD)4 cells (> 400/mm^3) and low HIV viral loads (< 30,000 copies/ml plasma) not requiring anti-HIV therapy are eligible
Who cannot join
- Patients with core-binding factor AML (inv[16], t[8;21]) or t(15;17)
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; treatment with hydroxyurea is permitted during cycle 1 to maintain white blood cell (WBC) < 40,000/uL
- Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
- Patients with active central nervous system (CNS) malignancy
- Major surgery within 2 weeks before day 1
- Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
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- Patients with significantly diseased or obstructed gastrointestinal tract
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, myocardial infarction within 6 months prior to enrollment, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
- Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- Patients with advanced malignant solid tumors
- Patients who are not able to swallow capsules or tablets
- Patients with baseline corrected QT (QTc) > 500 ms
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Phase I Study of Pacritinib and Chemotherapy in Patients With Acute Myeloid Leukemia and FLT3 Mutations
This phase I trial studies the side effects and best dose of pacritinib when given together with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pacritinib and chemotherapy may be a better treatment for acute myeloid leukemia with FLT3 mutations.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of pacritinib in combination with 7+3 or decitabine (respective cohorts are independent of each other) in patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) with FLT3 mutations.
II. To define the specific toxicities, maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of these combinations.
III. To determine the recommended phase 2 dose (RP2D) of these combinations.
SECONDARY OBJECTIVES:
- To determine the rate and duration of complete remission (CR) +/- hematologic recovery of pacritinib and 7+3 or decitabine in AML.
II. To determine the overall response rate (ORR) and disease free survival at 1 year.
TERTIARY OBJECTIVES:
- To conduct pharmacokinetic studies of pacritinib in combination with chemotherapy.
II. To determine the impact of pacritinib on the inhibition of Janus kinase 2 (JAK2), FLT3, AXL receptor tyrosine kinase (AXL), signal transducer and activator of transcription 5A (STAT5), spleen tyrosine kinase (Syk).
III. To examine the exosome, cytokine, and chemokine changes of FLT3 down-stream inhibition by pacritinib.
IV. To examine resistance patterns associated with treatment with pacritinib. V. To examine baseline cytogenetic, GTP binding protein overexpressed in skeletal muscle (GEM) signature, and long non-coding (Lnc) ribonucleic acid (RNA) signature and mutational status of the AML tumor cells to better identify subsets of patients with highest likelihood of responding to therapy.
OUTLINE: This is a dose-escalation study of pacritinib. Patients are assigned to 1 of 2 treatment arms.
COHORT A:
INDUCTION: Patients receive pacritinib orally (PO) on days 1-21, cytarabine intravenously (IV) every 24 hours on days 5-11, and daunorubicin hydrochloride IV every 24 hours on days 5-7. Treatment repeats every 28 days for 1-2 courses in the absence of disease progression or unacceptable toxicity.
COHORT B:
INDUCTION: Patients receive pacritinib PO on days 1-21 and decitabine IV every 24 hours on days 5-14. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients achieving CR will proceed with transplant evaluation (if appropriate). Transplant-ineligible patients will receive maintenance courses of pacritinib PO on days 1-21 and decitabine IV over 1 hour daily on days 1-5. Maintenance courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
- Conditions
- Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Being tested
- Pacritinib, Cytarabine, Daunorubicin Hydrochloride, Decitabine, Laboratory Biomarker Analysis
- 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 Oral JAK2 Inhibitor SB1518, SB1518
Given PO
CytarabineDrug
Also called CHX-3311, U-19920
Given IV
Daunorubicin HydrochlorideDrug
Also called DNM, DNR, DRB
Given IV
DecitabineDrug
Also called 5AZA, DAC
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride) | Experimental | INDUCTION: Patients receive pacritinib PO on days 1-21, cytarabine IV every 24 hours on days 5-11, and daunorubicin hydrochloride IV every 24 hours on days 5-7. Treatment repeats every 28 days for 1-2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Pacritinib; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
| Cohort B (pacritinib, decitabine) | Experimental | INDUCTION: Patients receive pacritinib PO on days 1-21 and decitabine IV every 24 hours on days 5-14. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients achieving CR will proceed with transplant evaluation (if appropriate). Transplant-ineligible patients will receive maintenance courses of pacritinib PO on days 1-21 and decitabine IV over 1 hour daily on days 1-5. Maintenance courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Pacritinib; Drug: Decitabine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of pacritinib defined as the highest safely tolerated dose where, at most, one patient experiences DLT in 6 evaluable patients, with the next higher dose having at least 2 patients who experience DLT
Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Toxicities will be tabulated by type and grade and displayed in summary form. Further, all adverse event data that are graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment will be reviewed for completeness.
Measured: 28 days
Secondary outcomes (2)
Clinical response according to International Working Group criteria
The degree of response will be summarized within each stratum and at each dose level. ORR will also be presented for those patients treated at the MTD with an exact 95% confidence interval.
Measured: Up to at least 30 days post-treatment
Duration of response
For patients who achieve complete remission, duration of response will be reported.
Measured: Up to at least 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start12 Jan 2016
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bhavana Bhatnagar
- Sponsor type
- University, hospital or other
- Collaborators
- CTI BioPharma
- Responsible party
- Sponsor-investigator, Bhavana Bhatnagar, Ohio State University Comprehensive Cancer Center
- Investigators
- Bhavana Bhatnagar, DO, Principal investigator, Arthur G. James Cancer Hospital and Solove Research Institute at Wexner Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323607
- Sponsor's protocol ID
- OSU-14169
- Other IDs
- NCI-2014-02436
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2014
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pacritinib and Chemotherapy in Patients With Acute Myeloid Leukemia and FLT3 Mutations
- ClinicalTrials.gov ID
- NCT02323607
- Acronym / sponsor ID
- OSU-14169
- Conditions
- Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bhavana BhatnagarUniversity, hospital or other
- Collaborators
- CTI BioPharma
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of pacritinib when given together with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pacritinib and chemotherapy may be a better treatment for acute myeloid leukemia with FLT3 mutations.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of pacritinib in combination with 7+3 or decitabine (respective cohorts are independent of each other) in patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) with FLT3 mutations.
II. To define the specific toxicities, maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of these combinations.
III. To determine the recommended phase 2 dose (RP2D) of these combinations.
SECONDARY OBJECTIVES:
- To determine the rate and duration of complete remission (CR) +/- hematologic recovery of pacritinib and 7+3 or decitabine in AML.
II. To determine the overall response rate (ORR) and disease free survival at 1 year.
TERTIARY OBJECTIVES:
- To conduct pharmacokinetic studies of pacritinib in combination with chemotherapy.
II. To determine the impact of pacritinib on the inhibition of Janus kinase 2 (JAK2), FLT3, AXL receptor tyrosine kinase (AXL), signal transducer and activator of transcription 5A (STAT5), spleen tyrosine kinase (Syk).
III. To examine the exosome, cytokine, and chemokine changes of FLT3 down-stream inhibition by pacritinib.
IV. To examine resistance patterns associated with treatment with pacritinib. V. To examine baseline cytogenetic, GTP binding protein overexpressed in skeletal muscle (GEM) signature, and long non-coding (Lnc) ribonucleic acid (RNA) signature and mutational status of the AML tumor cells to better identify subsets of patients with highest likelihood of responding to therapy.
OUTLINE: This is a dose-escalation study of pacritinib. Patients are assigned to 1 of 2 treatment arms.
COHORT A:
INDUCTION: Patients receive pacritinib orally (PO) on days 1-21, cytarabine intravenously (IV) every 24 hours on days 5-11, and daunorubicin hydrochloride IV every 24 hours on days 5-7. Treatment repeats every 28 days for 1-2 courses in the absence of disease progression or unacceptable toxicity.
COHORT B:
INDUCTION: Patients receive pacritinib PO on days 1-21 and decitabine IV every 24 hours on days 5-14. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients achieving CR will proceed with transplant evaluation (if appropriate). Transplant-ineligible patients will receive maintenance courses of pacritinib PO on days 1-21 and decitabine IV over 1 hour daily on days 1-5. Maintenance courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride) | Experimental | Drug: Pacritinib, Drug: Cytarabine, Drug: Daunorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyINDUCTION: Patients receive pacritinib PO on days 1-21, cytarabine IV every 24 hours on days 5-11, and daunorubicin hydrochloride IV every 24 hours on days 5-7. Treatment repeats every 28 days for 1-2 courses in the absence of disease progression or unacceptable toxicity. |
| Cohort B (pacritinib, decitabine) | Experimental | Drug: Pacritinib, Drug: Decitabine, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyINDUCTION: Patients receive pacritinib PO on days 1-21 and decitabine IV every 24 hours on days 5-14. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients achieving CR will proceed with transplant evaluation (if appropriate). Transplant-ineligible patients will receive maintenance courses of pacritinib PO on days 1-21 and decitabine IV over 1 hour daily on days 1-5. Maintenance courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with AML and the presence of FLT3 mutation
- Patients with secondary AML or therapy related disease (t-AML) are eligible
- If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Total bilirubin < 2.0mg/dL unless due to Gilbert's disease
Key exclusion criteria (13 listed)
- Patients with core-binding factor AML (inv[16], t[8;21]) or t(15;17)
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; treatment with hydroxyurea is permitted during cycle 1 to maintain white blood cell (WBC) < 40,000/uL
- Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
- Patients with active central nervous system (CNS) malignancy
- Major surgery within 2 weeks before day 1
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: Oral JAK2 Inhibitor SB1518, SB1518Given PO | Drug | Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride), Cohort B (pacritinib, decitabine) |
| CytarabineAlso: CHX-3311, U-19920Given IV | Drug | Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride) |
| Daunorubicin HydrochlorideAlso: DNM, DNR, DRBGiven IV | Drug | Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride) |
| DecitabineAlso: 5AZA, DACGiven IV | Drug | Cohort B (pacritinib, decitabine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride), Cohort B (pacritinib, decitabine) |
| Pharmacological StudyAlso: pharmacological studiesCorrelative studies | Other | Cohort A (pacritinib, cytarabine, daunorubicin hydrochloride), Cohort B (pacritinib, decitabine) |
Primary outcome
MTD of pacritinib defined as the highest safely tolerated dose where, at most, one patient experiences DLT in 6 evaluable patients, with the next higher dose having at least 2 patients who experience DLT
Time frame: 28 days
Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Toxicities will be tabulated by type and grade and displayed in summary form. Further, all adverse event data that are graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment will be reviewed for completeness.
2 secondary outcomes
Clinical response according to International Working Group criteria
Time frame: Up to at least 30 days post-treatment
Duration of response
Time frame: Up to at least 30 days post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- The JameslineLink provided by the sponsor.
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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.
Bhavana Bhatnagar, DO principal investigator
Arthur G. James Cancer Hospital and Solove Research Institute at Wexner Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pacritinib, Cytarabine and Daunorubicin Hydrochloride in people with Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, run by Bhavana Bhatnagar 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 25 Jan 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD of pacritinib defined as the highest safely tolerated dose where, at most, one patient experiences DLT in 6 evaluable patients, with the next higher dose having at least 2 patients who experience DLT (time frame: 28 days). 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 25 Jan 2019.