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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT02869633
Phase
PHASE2
Status
Completed

Conditions

  • Blastoid Variant Mantle Cell Lymphoma
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Follicular Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Follicular Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Given by mouth
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Oct 2023
Primary completion
Nov 18, 2021
Completion
Oct 31, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib)
    Beginning between 60-90 days post donor stem cell transplant, patients receive ibrutinib PO QD until 1 year post donor stem cell transplant in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival Probability at 12-month Post HCT [ Time Frame: 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. ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
Stanford Cancer InstitutePalo AltoCalifornia94304-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALStanford Cancer Institute· Palo Alto, CADana-Farber Cancer Institute· Boston, MAVanderbilt-Ingram Cancer Center· Nashville, TNM D Anderson Cancer Center· Houston, TX

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