IRB #

STUDY00016830

Title

[NCI CIRB] A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype

Principal Investigator

Andy Chen

Study Purpose

The purpose of this study is to directly compare any good and bad effects of using an oral medication, ibrutinib, along with the AutoHCT versus AutoHCT alone. Ibrutinib is a cancer drug that may be effective against a certain type of DLBCL called “Activated B-Cell Subtype” (or “ABC”). Ibrutinib may be effective for patients who relapse after AutoHCT. Ibrutinib is already FDA-approved for use in patients with other types of cancers, such as chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom’s Macroglobulinemia. Though ibrutinib is FDA approved for use in patients with other types of cancer, it is investigational for this study. The researchers want to know if adding ibrutinib to the usual chemotherapy given with AutoHCT could prevent lymphoma from returning in the future. However, addition of this medication could also cause side effects.

This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be found better, the study approach would have to increase the chance of people with this type of lymphoma being alive and free of lymphoma from 40% to 67% at 2 years following AutoHCT. There will be about 296 people with “ABC” subtype DLBCL taking part in this study.

Medical Condition(s)

Relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) of the Activated B-Cell (ABC) Subtype

Eligibility Criteria

-At least 18 years old

-Have a certain type of diffuse large B-Cell lymphoma, called "Activated B-Cell" (or "ABC") subtype, that did not get better with treatment or has returned after previous treatment

-Subsequently received or are currently receiving second line therapy

-And being considered for an autologous hematopoietic stem cell transplantation (AutoHCT)

Age Range

18 - n/a

Healthy Volunteers Needed

No

Duration of Participation

If you join this study, you will receive chemotherapy with ibrutinib or placebo and AutoHCT followed by one year of ibrutinib or placebo pills. After you finish treatment, your investigator will continue to watch you for side effects and follow your condition for up to 5 years since you started the study. If you do not complete a year of treatment, your investigator will still watch you for side effects and follow your condition for up to 5 years since you started the study.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Alliance for Clinical Trials in Oncology, NCI National Clinical Trials Network

Recruitment End

12/31/2027

Compensation Provided

No


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