Disease: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Protocol: PCYC-1123-CA

A Multicenter Open-Label Phase 1b/2 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Study Schema (N=129)

Two phase study:
  • Phase 1b (Recruiting) – Dose escalation study with relapsed/refractory DLBCL. Various cohorts may be explored to determine the lenalidomide dose
  • Phase 2 (Not Recruiting) – Study for subjects with non-germinal center B-cell (non-GCB) DLBCL. Treatment includes ibrutinib in combination with lenalidomide and rituximab
pcyc-1123-ca

Primary Objective

Phase 1b
  • Determination of Maximum Tolerated Dose (MTD) or Recommended Phase 2 (RP2) Dose
  • Safety and tolerability of treatment combination
Phase 2
  • Efficacy of treatment combination as assessed by overall response rate (ORR)

Key Eligibility Criteria

(Not a complete list of inclusion and exclusion criteria)

Inclusion Criteria:
  • Pathologically confirmed relapsed/refractory DLBCL (Phase 1b)
  • Must have previously received first line treatment regimen
  • Must be ineligible for high dose therapy/ stem cell transplantation
  • Measurable disease sites on CT scan (>1.5 cm in longest dimension)
  • Men and women ≥18 years of age
  • ECOG<2
  • Adequate hepatic and renal function
  • Adequate hematologic function

Exclusion Criteria:
  • Medically apparent central nervous system lymphoma or leptomeningeal disease
  • History of allogeneic stem-cell (or other organ) transplantation
  • Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
  • Radio- or toxin-immunoconjugates within 10 weeks
  • Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.

 

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The information provided herein may contain references to ibrutinib or a use of ibrutinib which has not been approved by any regulatory agency. Providing this information should not be construed as recommending the use of ibrutinib for uses which may not have been approved by any regulatory agency. The safety and efficacy of the investigational use of ibrutinib has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. For additional information, you may visit www.clinicaltrials.gov. For products approved by any regulatory agency please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product for its approved indications.