Post-transplant Lymphoproliferative DisorderPhase 2NCT04337827
Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder
A Phase 2 study testing Rituximab, Acalabrutinib and CT scans in people with Post-transplant Lymphoproliferative Disorder, run by Deepa Jagadeesh at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how effective rituximab and acalabrutinib are when given as a combination treatment for newly diagnosed B cell post transplant lymphoproliferative disorder (PTLD). Currently there is no approved therapy for PTLD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-transplant Lymphoproliferative Disorder
- What is being tested?
- Rituximab, Acalabrutinib and CT scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 19 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a biopsy confirmed newly diagnosed CD20 positive B cell PTLD.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG 3 will be permitted if the decline in performance status is due to lymphoma. [See Appendix 1]
- Subjects must have adequate hematologic, hepatic, and renal function as defined below:
- Hemoglobin ≥ 8 gm/dL
- Absolute neutrophil count ≥500/mcL (unless documented bone marrow involvement with lymphoma)
- Platelet count ≥50000/mcL (unless there is documented bone marrow involvement with lymphoma)
Show all 13Show fewer
- Prothrombin time/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of Lupus anticoagulant) < 2x ULN.
- Total bilirubin ≤1.5X upper limit of normal (ULN)
- Creatinine ≤2.5X upper limit of normal (ULN)
- Alanine aminotransferase/aspartate aminotransferase (ALT/AST) < 2.5 X or ≤5X ULN for patients with document hepatic involvement with lymphoma
- Women of childbearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) during treatment and for 12 months after last dose of study treatment. Women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Subjects must be willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- Subjects must have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Who cannot join
- Prior treatment with any BTK inhibitor
- Subjects receiving any other investigational agents or participating in another therapeutic clinical trial.
- Subjects with active (treated or untreated) brain metastases/ central nervous system (CNS) disease (including but not limited to CNS PTLD) will be excluded from this clinical trial
- Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, early stage prostate cancer or other cancer from which the subject has been disease free for ≥ 3 years
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll in the study.
- Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication.
Show all 20Show fewer
- Known history of infection with HIV. HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with acalabrutinib.
- Patients with uncontrolled concurrent illness like active infection (eg, bacterial, viral, or fungal) requiring IV antibiotics or psychiatric illness/social situations that would limit compliance with study requirements
- Known history of drug-specific hypersensitivity or anaphylaxis to acalabrutinib or rituximab (including active product or excipient components).
- Active bleeding, history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
- Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- History of significant cerebrovascular disease or event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.
- History of progressive multifocal leukoencephalopathy (PML)
- Breastfeeding or pregnant. Pregnant or breastfeeding women are excluded from this study because it is unknown how acalabrutinib and rituximab can affect the fetus or infant. Rituximab can cross the placenta and is found in breast milk. Acalabrutinib has been found in the breast milk of animals and there is not significant data regarding its effect during pregnancy.
- Vaccination with live virus vaccines is not allowed within 4 weeks of study treatment of or during treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase II Study of Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder (PTLD)
The purpose of this study is to evaluate how effective rituximab and acalabrutinib are when given as a combination treatment for newly diagnosed B cell post transplant lymphoproliferative disorder (PTLD). Currently there is no approved therapy for PTLD. Rituximab alone is commonly used and works in some cases, but not others. In addition, participants with PTLD have trouble tolerating therapies with large amounts of side effects due to their health conditions and medications for their transplant. Due to these reasons the study team is looking for a new treatment with novel targeted agents in order to improve outcomes and to minimize toxicity.
Based on emerging data of clinical efficacy of acalabrutinib in B cell malignancies and an unmet need for novel therapies in PTLD, this study will investigate the use of rituximab and acalabrutinib in participants with newly diagnosed B cell PTLD.
Read the detailed description
This is a non-randomized phase II study of acalabrutinib plus rituximab in newly diagnosed B-cell PTLD in participants with both solid organ transplant (SOT) and Bone marrow transplant (BMT).
Acalabrutinib is an inhibitor of Bruton Tyrosine Kinase (BTK). BTK is important in B cells and plays a role in the development of PTLD. Acalabrutinib is approved in the US for the treatment of adult participants with indolent lymphoma, mantle cell lymphoma, and is being evaluated to treat other lymphomas.
Rituximab has been approved for treatment of B cell non-Hodgkin lymphoma (NHL). While not approved for PTLD, it has become the mainstay of treatment.
The primary objective of this study is to determine the overall response rate to combination treatment with rituximab and acalabrutinib in patients with PTLD.
The secondary objectives of this study is to determine response rates, survival, failure rates, and safety elements in participants with PTLD treated with combination rituximab and acalabrutinib.
- Being tested
- Rituximab, Acalabrutinib, CT scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan, Mabthera
Weekly x 4 weeks.
If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto Long Term Follow Up (LTFU).
AcalabrutinibDrug
Also called ACP-196
100mg twice per day (BID) x 4 weeks (28 day cycle)
If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto LTFU.
CT scansDiagnostic test
2 weeks (day 36 ± 5 days) after end of cycle 1 treatment.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab and Acalabrutinib | Experimental | Participants will receive treatment of Rituximab weekly for 4 weeks, and Acalabrutinib twice daily for 4 weeks. Response assessment via diagnostic CT scans will dictate further treatment decisions. Receives: Drug: Rituximab; Drug: Acalabrutinib; Diagnostic Test: CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR will be estimated along with 90% Confidence Intervals (CIs), and compared against the null using exact binomial test. Logistic regression model will be used to identify factors associated with response status.
Measured: Up to 8 weeks after treatment
Secondary outcomes (13)
Complete Response Rate (CRR)
CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria
Measured: at 6 months after treatment
Complete Response Rate (CRR)
CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria
Measured: at 12 months after treatment
Complete Response Rate (CRR)
CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria
Measured: at 24 months after treatment
Partial Response Rate (PRR)
PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria.
Measured: at 6 months after treatment
Partial Response Rate (PRR)
PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria.
Measured: at 12 months after treatment
Partial Response Rate (PRR)
PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria.
Measured: at 24 months after treatment
Duration of Response (DOR)
DOR is only measured in responders. DOR is defined as the time from documented response (CR or PR) to the time of confirmed disease progression or death due to any cause, whichever occurs first. Subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued study, or have initiated other non-protocol anti-tumor therapy (NPT) will be censored at the last tumor assessment when subjects are progression-free.
Measured: Up to 3 years after treatment
Progression Free Survival (PFS)
PFS as defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day)
Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Measured: at 6 months after treatment
Progression Free Survival (PFS)
PFS as defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day)
Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Measured: at 12 months after treatment
Progression Free Survival (PFS)
PFS as defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day)
Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Measured: at 24 months after treatment
Overall Survival (OS)
Overall survival (OS) is defined as the time from first dose to death from any cause. Data for subjects who are still alive at the time of data cutoff date, lost to follow-up, have discontinued the study (or, if no post-baseline assessment, at the time of first dose plus 1 day) will be censored on last assessment
Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Measured: Up to 3 years after treatment
Time to Treatment Failure (TTF)
TTF is measured from the time from study entry to any treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death.
Measured: Up to 3 years after treatment
Number of Participants With a Grade 3 Adverse Event (AE) or Higher
Safety as defined by number of participants with a grade 3 AE or higher
Measured: Up to 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start2 Sep 2020
- Primary completion27 Jun 2022
- Study completion19 Dec 2022
Why it stopped: Slow accrual
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 Post-transplant Lymphoproliferative DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepa Jagadeesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deepa Jagadeesh, Case Comprehensive Cancer Center
- Investigators
- Deepa Jagadeesh, MD, MPH, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337827
- Sponsor's protocol ID
- CASE3419
- Status last verified
- Mar 2024
- First submitted
- 6 Apr 2020
- Last updated
- 10 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual patient data in order to protect the confidentiality of the subjects who enroll on this study
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder (PTLD)
- ClinicalTrials.gov ID
- NCT04337827
- Acronym / sponsor ID
- CASE3419
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Deepa JagadeeshUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Posted 10 Apr 2024
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 evaluate how effective rituximab and acalabrutinib are when given as a combination treatment for newly diagnosed B cell post transplant lymphoproliferative disorder (PTLD). Currently there is no approved therapy for PTLD. Rituximab alone is commonly used and works in some cases, but not others. In addition, participants with PTLD have trouble tolerating therapies with large amounts of side effects due to their health conditions and medications for their transplant. Due to these reasons the study team is looking for a new treatment with novel targeted agents in order to improve outcomes and to minimize toxicity.
Based on emerging data of clinical efficacy of acalabrutinib in B cell malignancies and an unmet need for novel therapies in PTLD, this study will investigate the use of rituximab and acalabrutinib in participants with newly diagnosed B cell PTLD.
Detailed description
This is a non-randomized phase II study of acalabrutinib plus rituximab in newly diagnosed B-cell PTLD in participants with both solid organ transplant (SOT) and Bone marrow transplant (BMT).
Acalabrutinib is an inhibitor of Bruton Tyrosine Kinase (BTK). BTK is important in B cells and plays a role in the development of PTLD. Acalabrutinib is approved in the US for the treatment of adult participants with indolent lymphoma, mantle cell lymphoma, and is being evaluated to treat other lymphomas.
Rituximab has been approved for treatment of B cell non-Hodgkin lymphoma (NHL). While not approved for PTLD, it has become the mainstay of treatment.
The primary objective of this study is to determine the overall response rate to combination treatment with rituximab and acalabrutinib in patients with PTLD.
The secondary objectives of this study is to determine response rates, survival, failure rates, and safety elements in participants with PTLD treated with combination rituximab and acalabrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab and Acalabrutinib | Experimental | Drug: Rituximab, Drug: Acalabrutinib, Diagnostic Test: CT scansParticipants will receive treatment of Rituximab weekly for 4 weeks, and Acalabrutinib twice daily for 4 weeks. Response assessment via diagnostic CT scans will dictate further treatment decisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must have a biopsy confirmed newly diagnosed CD20 positive B cell PTLD.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG 3 will be permitted if the decline in performance status is due to lymphoma. [See Appendix 1]
- Subjects must have adequate hematologic, hepatic, and renal function as defined below:
- Women of childbearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) during treatment and for 12 months after last dose of study treatment. Women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Subjects must be willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Key exclusion criteria (20 listed)
- Prior treatment with any BTK inhibitor
- Subjects receiving any other investigational agents or participating in another therapeutic clinical trial.
- Subjects with active (treated or untreated) brain metastases/ central nervous system (CNS) disease (including but not limited to CNS PTLD) will be excluded from this clinical trial
- Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, early stage prostate cancer or other cancer from which the subject has been disease free for ≥ 3 years
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll in the study.
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 |
|---|---|---|
| RituximabAlso: Rituxan, MabtheraWeekly x 4 weeks. If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto Long Term Follow Up (LTFU). | Drug | Rituximab and Acalabrutinib |
| AcalabrutinibAlso: ACP-196100mg twice per day (BID) x 4 weeks (28 day cycle) If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto LTFU. | Drug | Rituximab and Acalabrutinib |
| CT scans2 weeks (day 36 ± 5 days) after end of cycle 1 treatment. | Diagnostic test | Rituximab and Acalabrutinib |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 8 weeks after treatment
ORR will be estimated along with 90% Confidence Intervals (CIs), and compared against the null using exact binomial test. Logistic regression model will be used to identify factors associated with response status.
13 secondary outcomes
Complete Response Rate (CRR)
Time frame: at 6 months after treatment
Complete Response Rate (CRR)
Time frame: at 12 months after treatment
Complete Response Rate (CRR)
Time frame: at 24 months after treatment
Partial Response Rate (PRR)
Time frame: at 6 months after treatment
Partial Response Rate (PRR)
Time frame: at 12 months after treatment
Partial Response Rate (PRR)
Time frame: at 24 months after treatment
Duration of Response (DOR)
Time frame: Up to 3 years after treatment
Progression Free Survival (PFS)
Time frame: at 6 months after treatment
Progression Free Survival (PFS)
Time frame: at 12 months after treatment
Progression Free Survival (PFS)
Time frame: at 24 months after treatment
Overall Survival (OS)
Time frame: Up to 3 years after treatment
Time to Treatment Failure (TTF)
Time frame: Up to 3 years after treatment
Number of Participants With a Grade 3 Adverse Event (AE) or Higher
Time frame: Up to 3 years after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to share individual patient data in order to protect the confidentiality of the subjects who enroll on this study
Related trials for Post-transplant Lymphoproliferative Disorder
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
Active, not recruitingPhase 2
Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
Classic Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 1/2
A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance
Acute Lymphoblastic Leukemia, B-cell Non Hodgkin Lymphoma
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
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.
Deepa Jagadeesh, MD, MPH principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
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 Rituximab, Acalabrutinib and CT scans in people with Post-transplant Lymphoproliferative Disorder, run by Deepa Jagadeesh 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 13 inclusion and 20 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 10 Apr 2024. 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 10 Apr 2024). 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?
Overall Response Rate (ORR) (time frame: Up to 8 weeks after treatment). 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 10 Apr 2024.