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

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ClinicalTrials.gov Identifier: NCT02077166
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Janssen Research & Development, LLC
Celgene Corporation
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Drug: Ibrutinib Drug: Lenalidomide Drug: Rituximab Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Phase 1: Dose Level -1
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Experimental: Phase 1: Dose Level 1
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Experimental: Phase 1: Dose Level 1+
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Experimental: Phase 1: Dose Level 2
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Experimental: 2Phase 1: Dose Level 3
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab
Experimental: Phase 2
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab



Primary Outcome Measures :
  1. 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 ]
  2. Phase 2: Overall response rate (ORR) [ Time Frame: Up to 45 months ]

Secondary Outcome Measures :
  1. Phase 1: Overall response rate(ORR) [ Time Frame: Up to 45 months ]
  2. Phase 2: Duration of response (DOR) [ Time Frame: Up to 45 months ]
  3. Phase 2: Progression free survival (PFS) [ Time Frame: Up to 45 months ]
  4. Phase 2: Overall survival (OS) [ Time Frame: Up to 45 months ]
  5. Phase 2: Complete response (CR) [ Time Frame: Up to 45 months ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077166


  Show 40 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Celgene Corporation
Investigators
Study Director: Jutta K. Neuenburg, MD, PhD Pharmacyclics LLC.

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02077166     History of Changes
Other Study ID Numbers: PCYC-1123-CA
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: February 2018

Keywords provided by Pharmacyclics LLC.:
DLBCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Rituximab
Thalidomide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents