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Protocol No. A051301

Principal Investigator Kenkre, Vaishalee

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title 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

Objective The purpose of this study is to directly compare any good and bad effects of using an oral medication, ibrutinib, along with the autologous hematopoietic stem cell transplantation (AutoHCT) versus AutoHCT alone. Ibrutinib is a cancer drug that may be effective against a certain type of diffuse large B-Cell lymphoma ( DLBCL) called "Activated B-Cell Subtype" (or "ABC"). Ibrutinib may be effective for patients who relapse after AutoHCT. The researchers want to know if adding ibrutinib to the usual chemotherapy given with AutoHCT could prevent your lymphoma from returning in the future.

Treatment Ibrutinib is a first-in-class selective inhibitor of Bruton's tyrosine kinase (BTK). 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.

Description A computer will assign you by chance to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. Your chance of being assigned to either group is 50%. Neither you nor your doctors will know whether you are receiving ibrutinib or placebo. This study has two treatment groups. In Group 1, for the first 6 days, you will get the usual chemotherapy (BEAM or CBV), plus the study drug ibrutinib. Then, you will receive ibrutinib for 12 months following AutoHCT. For Group 2, for the first 6 days, you will get the usual chemotherapy (BEAM or CBV), plus a placebo (a pill that looks like the study drug but contains no medication). Then, you will receive a placebo for 12 months following AutoHCT. However, if you were to progress or relapse while taking the placebo, you would be offered treatment with the study drug, ibrutinib, at that time. Ibrutinib/placebo should be swallowed whole with water.

Key Eligibility
  • Diagnosis of diffuse large B-cell lymphoma, high grade B-cell lymphoma not otherwise specified, or B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma
  • Determination of ABC subtype by pre-registration central review
  • Patient must be deemed eligible to proceed with high-dose chemotherapy and autologous stem cell transplantation by local transplant center
  • Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy
  • No more than 3 prior regimens for large cell component (e.g. one induction and two salvage therapies). Monoclonal antibody alone or involved field/involved site radiotherapy do not count as lines of therapy
  • Prior use of ibrutinib is allowed unless patient has had disease progression while receiving ibrutinib
  • Patient must have chemosensitive disease as defined by at least a partial response to salvage therapy at their latest assessment
  • Not pregnant and not nursing
  • Age ≥ 18 years
  • HIV infected patients are eligible provided they meet all other eligibility criteria
  • Patients with a history of CNS or meningeal involvement must be in a documented remission
  • Patients cannot have active central nervous system or meningeal involvement by lymphoma
  • Patients cannot have active hepatitis B or C infection
  • Patients cannot require warfarin or similar vitamin K antagonists. These drugs are prohibited 28 days prior to the first treatment and throughout the trial

Applicable Disease Sites Lymphoma

Therapies Involved Bone Marrow Transplant; Cytotoxic Chemotherapy

Drugs Involved Imbruvica (ibrutinib); ibrutinib; placebo

Status Open

Participating Institutions UW Hospital and Clinics