Ibrutinib + Stem Cell Transplant for Lymphoma
Trial Summary
What is the purpose of this trial?
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you should not require chronic use of strong CYP3A inhibitors or inducers, and you should not need therapeutic doses of steroids unless necessary. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Ibrutinib in treating lymphoma?
Ibrutinib has been shown to be effective in treating certain types of blood cancers, like chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), by improving survival rates and response to treatment. It works by blocking signals that help cancer cells grow, and has been approved for use in these conditions due to its positive results in clinical trials.12345
Is the combination of Ibrutinib and Stem Cell Transplant generally safe for humans?
Ibrutinib (Imbruvica) has been used in various treatments and is generally considered to have an acceptable safety profile, but it can cause side effects like bleeding, infections, and heart issues. The most common side effects include muscle pain, fever, pneumonia, stomach pain, mouth sores, diarrhea, and headache. While these findings are from studies on different conditions, they provide some insight into the safety of Ibrutinib in humans.12456
How is the drug Ibrutinib unique for treating lymphoma?
Ibrutinib is unique because it is an oral medication that specifically targets Bruton's tyrosine kinase, a key player in B-cell receptor signaling, which helps reduce the growth of cancerous B cells. This mechanism makes it a novel option compared to traditional chemotherapy, and it is particularly effective in patients with certain genetic mutations like del(17p) or TP53 mutation.12457
Research Team
Charalambos B Andreadis
Principal Investigator
Alliance for Clinical Trials in Oncology
Eligibility Criteria
Adults with relapsed or refractory diffuse large B-cell lymphoma eligible for stem cell transplant can join. They must have responded at least partially to prior chemotherapy, be in good physical condition, and not have severe heart, lung, liver issues or active infections like hepatitis B/C or HIV with complications. Pregnant/nursing individuals and those on certain drugs are excluded.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Conditioning Regimen
Patients receive either the BEAMi or CBVi regimen, including ibrutinib or placebo, followed by high-dose chemotherapy to prepare for stem cell transplant
Transplant
Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant
Continuation Regimen
Patients receive ibrutinib or placebo for 12 cycles, starting 30-60 days post-transplant, in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Autologous Bone Marrow Transplantation
- Autologous Hematopoietic Stem Cell Transplantation
- Ibrutinib
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor