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 range18 Years
SexALL
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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 ā„ 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 responsā¦
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.