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

Summary

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.

Conditions

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

Interventions

PROCEDURE

Autologous Bone Marrow Transplantation

Undergo autologous hematopoietic progenitor cells or bone marrow transplant

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous hematopoietic progenitor cells or bone marrow transplant

DRUG

Carmustine

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV

DRUG

Etoposide

Given IV

DRUG

Ibrutinib

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

OTHER

Pharmacogenomic Study

Correlative studies

OTHER

Placebo Administration

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Charalambos B Andreadis · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-12

Primary Completion

2024-06-10

Completion

2026-12-23

Countries

• United States
• Saudi Arabia

Study Locations