Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type
• Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Autologous Bone Marrow Transplantation — PROCEDURE
  Undergo autologous hematopoietic progenitor cells or bone marrow transplant
• Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo autologous hematopoietic progenitor cells or bone marrow transplant
• Carmustine — DRUG
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Cytarabine — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Ibrutinib — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Melphalan — DRUG
  Given IV
• Pharmacogenomic Study — OTHER
  Correlative studies
• Placebo Administration — OTHER
  Given PO

Study Details

This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.

Key Dates

Start date

Oct 12, 2016

Status verified

Dec 2025

Primary completion

Jun 10, 2024

Completion

Dec 23, 2026

Study Design

Enrollment

94 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (ibrutinib, chemotherapy, autoHCT)
  CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen. BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1. CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0. CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
• Placebo Comparator: Arm II (placebo, chemotherapy, autoHCT)
  CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I. TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0. CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.

Primary Outcome Measure

24-month Progression-free Survival (PFS), Defined as the Proportion of Patients Who Are Alive and Progression-free 2 Years From Randomization [ Time Frame: Time between registration and disease progression or death, whichever comes first, assessed at 24 months ]

Locations (280)

Find similar trials in Anchorage, AK

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