Phase II Study of Palbociclib and Ibrutinib for Treating Mantle Cell Lymphoma
Sponsor: Alliance Foundation Trials, LLC.
ClinicalTrials ID:NCT03478514
This clinical trial is testing a combination of two drugs, palbociclib and ibrutinib, to see if they can effectively treat patients with mantle cell lymphoma who have already received treatment before. The study aims to evaluate how well this combination works and its safety.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of combining two drugs, palbociclib and ibrutinib, for patients with mantle cell lymphoma who have been treated previously. The main goal is to see how long patients live without the disease getting worse. Other goals include measuring the overall response rate, complete response rate, duration of response, overall survival, and any side effects. Participants will take palbociclib for 21 days followed by a 7-day break, and ibrutinib continuously, in 28-day cycles. Treatment will continue until the disease progresses, side effects become unacceptable, or the patient decides to stop.
Description
In this study, patients will receive two medications: palbociclib and ibrutinib. Palbociclib is taken as a pill once a day for 21 days, followed by a 7-day break. Ibrutinib is taken as a pill every day without a break. Patients will continue taking these medications until their disease worsens, they experience severe side effects, or they choose to stop participating.
Doctors will use scans like PET/CT or CT every three cycles during the first year and every six cycles after that to check how the cancer is responding. If a complete response is suspected, a PET scan will confirm it. For patients with cancer in the bone marrow, a bone marrow biopsy will be done to confirm a complete response.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of mantle cell lymphoma (MCL) with specific genetic markers.
- Must have measurable disease, such as a tumor at least 1.5 cm in size or a specific number of cancer cells in the blood.
- Must have received at least one previous treatment for MCL.
- Patients who had an autologous stem cell transplant are eligible; those who had an allogeneic transplant must not be on immunosuppressive therapy and have no ongoing transplant-related issues.
- Must be 18 years or older.
- Must have a performance status score of 2 or less, indicating they are able to carry out daily activities.
- Must have normal organ and bone marrow function based on specific lab tests.
- Must be able to provide written consent and be willing to take oral medication.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after.
- No active hepatitis B or C infections.
- HIV-positive patients are eligible if they meet specific criteria, including controlled viral load and no history of AIDS-defining conditions.
Exclusion Criteria
- Cannot have previously taken CDK4/6 inhibitors or BTK inhibitors within 90 days before joining the study.
- Cannot have cancer that has spread to the brain or spinal cord.
- Cannot be taking other experimental treatments.
- Cannot have allergies to similar drugs.
- Cannot be taking certain medications that affect how the study drugs work.
- Cannot have uncontrolled illnesses like heart failure, unstable angina, or severe psychiatric conditions.
- Cannot have had a heart attack within six months before joining the study.
- Pregnant or breastfeeding women cannot participate.
- Cannot have significant liver disease or another active cancer that affects survival.
- Cannot have bleeding disorders or require regular blood transfusions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010 | Duarte | California |
| University of Maryland, Greenebaum Comprehensive Cancer Center | 21201 | Baltimore | Maryland |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| St. Joseph Mercy Hospital Cancer Care Center | 48197 | Ypsilanti | Michigan |
| Roswell Park Comprehensive Cancer Center | 14263 | Buffalo | New York |
| Weill Cornell Medical College | 10065 | New York | New York |
| University of North Carolina | 27599 | Chapel Hill | North Carolina |
| Ohio State University | 43210 | Columbus | Ohio |
| Medical University of South Carolina - Hollings Cancer Center | 29425 | Charleston | South Carolina |
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