Clinical Trials /

Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT02077166

Description:

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) not eligible for transplant.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: PCYC-1123-CA
  • NCT ID: NCT02077166

Conditions

  • Relapsed Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Interventions

DrugSynonymsArms
IbrutinibPhase 1: Dose Level -1
LenalidomidePhase 1: Dose Level -1
RituximabPhase 1: Dose Level -1

Purpose

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) not eligible for transplant.

Detailed Description

      Phase 1b: In the dose escalation portion of the study, various cohorts with escalating doses
      of lenalidomide may be explored, using the 3+3+3 principle for dose determination.

      Phase 2: This will be conducted as an international, multicenter, open-label study. Eligible
      subjects will receive ibrutinib, lenalidomide and rituximab.
    

Trial Arms

NameTypeDescriptionInterventions
Phase 1: Dose Level -1ExperimentalIbrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
  • Ibrutinib
  • Lenalidomide
  • Rituximab
Phase 1: Dose Level 1ExperimentalIbrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
  • Ibrutinib
  • Lenalidomide
  • Rituximab
Phase 1: Dose Level 1+ExperimentalIbrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
  • Ibrutinib
  • Lenalidomide
  • Rituximab
Phase 1: Dose Level 2ExperimentalIbrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
  • Ibrutinib
  • Lenalidomide
  • Rituximab
2Phase 1: Dose Level 3ExperimentalIbrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
  • Ibrutinib
  • Lenalidomide
  • Rituximab
Phase 2ExperimentalIbrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
  • Ibrutinib
  • Lenalidomide
  • Rituximab

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed relapsed/ refractory DLBCL

          -  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)

          -  PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Determine the maximally tolerated dose (MTD) and /or the recommended Phase 2 (RP2) dose of lenalidomide in combination with fixed doses of ibrutinib and rituximab in subjects with relapsed or refractory DLBCL.
Time Frame:Up to 45 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Phase 1: Overall response rate(ORR)
Time Frame:Up to 45 months
Safety Issue:
Description:
Measure:Phase 2: Duration of response (DOR)
Time Frame:Up to 45 months
Safety Issue:
Description:
Measure:Phase 2: Progression free survival (PFS)
Time Frame:Up to 45 months
Safety Issue:
Description:
Measure:Phase 2: Overall survival (OS)
Time Frame:Up to 45 months
Safety Issue:
Description:
Measure:Phase 2: Complete response (CR)
Time Frame:Up to 45 months
Safety Issue:
Description:
Measure:Phase 2: Safety and tolerability of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed or refractory non-GCB DLBCL.
Time Frame:Up to 45 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pharmacyclics LLC.

Trial Keywords

  • DLBCL

Last Updated

May 19, 2017