Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant (NCT02869633) | Clinical Trial Compass
CompletedPhase 2
Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant
United States23 participantsStarted 2016-11
Plain-language summary
This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
PRE-STEM CELL TRANSPLANT (SCT)
* Patients undergoing their first T cell replete allo-HCT for chronic lymphocytic leukemia (CLL), Hodgkin Lymphoma (HL), or the following subtypes of Non-Hodgkin lymphoma: Mantle cell lymphoma (MCL) and follicular center cell lymphoma (FL)
* Meeting institutional criteria for allo-HCT. Ejection fraction by echocardiogram or MUGA \>40%, pulmonary function test with adjusted DLCO ≥ 60%
* Matched (8/8) or mismatched (7/8) related, unrelated HCT
* Stem cell source: bone marrow, peripheral blood stem cell
* Disease criteria:
Cohort A
Chronic lymphocytic leukemia
* Disease burden: lymph node size \< 5 cm and/or extra-nodal involvement \< 5 cm AND
* 17 p deletion (detected by any assay) (\> or equal to 20% of cells involved if assay is conventional cytogenetics or fluorescence in situ hybridization \[FISH\]) or NOTCH mutation at any time point during disease course; patient should have received at least 1 line of therapy; prior ibrutinib therapy is permitted OR
* Relapsed/refractory chronic lymphocytic leukemia \> or equal to 2 lines of therapy; prior ibrutinib therapy is permitted
Mantle cell lymphoma
* Disease burden: lymph node size \< 5 cm and/or extra-nodal involvement \< 5 cm AND
* Relapsed/refractory mantle cell lymphoma \> or equal to 1 line of therapy. Prior ibrutinib therapy is permitted. Prior autologous hematopoietic cell transplant is permitted. OR
* Mantle cell lymphoma blastoid variant in first complete respons…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival Probability at 12-month Post HCT
Timeframe: Time to progression, or relapse of the underlying disease for which transplant was undertaken, or death from any non-relapse causes, assessed 12 months post HCT.