Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant

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 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 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 response (CR1) or high risk mantle cell lymphoma being considered for allo hematopoietic cell transplant in CR1

Cohort B

Follicular lymphoma

Disease burden: lymph node size or equal to 2 lines of therapy. Prior ibrutinib therapy is permitted

Hodgkin disease

• Disease burden: lymph node size or equal to 2 lines of therapy.
• Preparative regimen: both reduced intensity and ablative regimens are permitted. Each center will pre-specify the regimen they intend to use during the conduct of the study
• Donor criteria: HLA ≥ 7/8 related or unrelated donors.
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
• Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study
• Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
• Prior to Administration of Ibrutinib (Day 60 to Day 90 post hematopoietic cell transplant)
• Karnofsky performance status (KPS) > or equal to 60%
• Engraftment of neutrophils (absolute neutrophil count [ANC] >= 1.0 X 10^9/L) for 3 days without granulocyte colony-stimulating factor (g-csf) support
• Platelets > or equal to 100, 000/mm^3 or > or equal to = 50,000/mm^3 if bone marrow involvement independent of transfusion support in either situation
• Glomerular filtration rate (GFR) > or equal to 30 ml/min
• Liver function tests (LFTs) (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) equal to or or equal to 51% as measured by CD3 and CD33 (or other myeloid marker)

Exclusion Criteria

PRE-SCT

• Progression of chronic lymphocytic leukemia or mantle cell lymphoma or follicular lymphoma or HD at time of transplant
• Use of Coumadin (warfarin) or other vitamin-K antagonists for anticoagulation; non-Coumadin anticoagulation is permitted
• Known central nervous system involvement
• Active uncontrolled bacterial or invasive fungal infections
• History of malignancy other than the underlying disease unless treated with a curative intent a