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

Description

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.

Study Start Date

September, 01 2016

Estimated Completion Date

October 2020

Interventions

  • Other: Laboratory Biomarker Analysis
  • Drug: Ibrutinib

Study ID

Vanderbilt-Ingram Cancer Center -- VICC BMT 1651

Status

Recruiting

Trial ID

NCT02869633

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

75

Sponsor

Vanderbilt-Ingram Cancer Center

Inclusion Criteria

  • PRE-STEM CELL TRANSPLANT (SCT)
  • Patients undergoing their first T-cell replete allogenic (allo)-hematopoietic cell transplant for chronic lymphocytic leukemia, mantle cell lymphoma, follicular lymphoma (FL), Hodgkin disease (HD)
  • Meeting institutional criteria for allo-hematopoietic cell transplant
  • ejection fraction by echocardiogram or multi-gated acquisition scan (MUGA) > 40%, pulmonary function test with adjusted diffusion capacity of the lung for carbon monoxide (DLCO) >= 60%
  • Matched (8/8) or mismatched (7/8) related, unrelated hematopoietic cell transplant
  • 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) (>= 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 >= 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
  • Relapsed/refractory mantle cell lymphoma >= 1 line of therapy
  • prior ibrutinib therapy is permitted prior autologous hematopoietic cell transplant is permitted
  • 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 < 5 cm and/or extra-nodal involvement < 5 cm AND
  • Relapsed/refractory follicular lymphoma >= 2 lines of therapy
  • prior ibrutinib therapy is permitted
  • Hodgkin disease
  • Disease burden: lymph node size < 5 cm and/or extra-nodal involvement < 5 cm AND
  • Relapsed/refractory Hodgkin disease >= 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
  • 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) >= 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 >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement independent of transfusion support in either situation
  • Glomerular filtration rate (GFR) >= 30 ml/min
  • Liver function tests (LFTs) (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) =< 3 X upper limit of normal (ULN)
  • Total bilirubin =< 1.5 mg/dL X ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Predominant donor chimerisms as measured by CD3 and CD33 (or other myeloid marker)
  • DONOR: Human leukocyte antigen (HLA) >= 7/8 related or unrelated donors

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 (CNS) involvement
  • Active uncontrolled bacterial or invasive fungal infections
  • History of malignancy other than the underlying disease unless treated with a curative intent and/or no evidence of disease for at least 3 years (y) OR expected to be cured with SCT
  • Planned use of post-hematopoietic cell transplant cyclophosphamide for graft versus host disease prophylaxis
  • Anticipated planned donor lymphocyte infusion in the first 3 months post-SCT
  • T deplete hematopoietic cell transplant
  • Umbilical cord hematopoietic cell transplant
  • History of stroke or intracranial hemorrhage within 6 months of enrollment
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Known human immunodeficiency syndrome (HIV)
  • Active hepatitis B or C virus
  • PRIOR TO ADMINISTRATION OF IBRUTINIB (DAY 60-DAY 90 POST SCT)
  • In the critical care unit, or use of mechanical ventilation or use of renal replacement therapy at any time post hematopoietic cell transplant and prior to administration of ibrutinib
  • Active uncontrolled stage 3-4 acute gastrointestinal (GI) graft versus host disease prior to administration of ibrutinib
  • Active uncontrolled stage 4 acute liver graft versus host disease prior to administration of ibrutinib
  • Evidence of progressive disease as compared to pre-hematopoietic cell transplant (persistence of disease is permitted)
  • Prednisone equivalent of > 2m/kg for treatment of graft versus host disease prior to administration of ibrutinib
  • Use of second line systemic therapy for treatment of acute graft versus host disease prior to administration of ibrutinib
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
  • Major surgery or a wound that has not fully healed within 4 weeks of starting ibrutinib
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
  • Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
  • Vaccinated with live, attenuated vaccines within 4 weeks of starting ibrutinib

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (24)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles Edwin Alyea MD None Edwin_Alyea@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles Edwin Alyea MD None Edwin_Alyea@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles Edwin Alyea MD None Edwin_Alyea@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles Edwin Alyea MD None Edwin_Alyea@dfci.harvard.edu
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles VICC Clinical Trials Information Program None None
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles VICC Clinical Trials Information Program None None
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles VICC Clinical Trials Information Program None None
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles VICC Clinical Trials Information Program None None
University of Alabama at Birmingham Cancer Center - Birmingham, Alabama 1,051.7 miles Luciano Costa MD None ljcosta@uabmc.edu
University of Alabama at Birmingham Cancer Center - Birmingham, Alabama 1,051.7 miles Luciano Costa MD None ljcosta@uabmc.edu
University of Alabama at Birmingham Cancer Center - Birmingham, Alabama 1,051.7 miles Luciano Costa MD None ljcosta@uabmc.edu
University of Alabama at Birmingham Cancer Center - Birmingham, Alabama 1,051.7 miles Luciano Costa MD None ljcosta@uabmc.edu
University of Kansas Cancer Center - Kansas City, Kansas 1,251.3 miles Joseph McGuirk MD None jmcguirk@kumc.edu
University of Kansas Cancer Center - Kansas City, Kansas 1,251.3 miles Joseph McGuirk MD None jmcguirk@kumc.edu
University of Kansas Cancer Center - Kansas City, Kansas 1,251.3 miles Joseph McGuirk MD None jmcguirk@kumc.edu
University of Kansas Cancer Center - Kansas City, Kansas 1,251.3 miles Joseph McGuirk MD None jmcguirk@kumc.edu
M D Anderson Cancer Center - Houston, Texas 1,609.9 miles Sairah Ahmed MD None sahmed3@mdanderson.org
M D Anderson Cancer Center - Houston, Texas 1,609.9 miles Sairah Ahmed MD None sahmed3@mdanderson.org
M D Anderson Cancer Center - Houston, Texas 1,609.9 miles Sairah Ahmed MD None sahmed3@mdanderson.org
M D Anderson Cancer Center - Houston, Texas 1,609.9 miles Sairah Ahmed MD None sahmed3@mdanderson.org
Stanford Cancer Institute - Palo Alto, California 2,694.6 miles David Miklos MD None dmiklos@partners.org
Stanford Cancer Institute - Palo Alto, California 2,694.6 miles David Miklos MD None dmiklos@partners.org
Stanford Cancer Institute - Palo Alto, California 2,694.6 miles David Miklos MD None dmiklos@partners.org
Stanford Cancer Institute - Palo Alto, California 2,694.6 miles David Miklos MD None dmiklos@partners.org

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