Overview

This trial is active, not recruiting.

Conditions diffuse large b cell lymphoma relapsed, diffuse large b cell lymphoma refractory
Treatments ibrutinib, da-epoch-r, ibrutinib, lenalidomide, da-epoch-r
Phase phase 1/phase 2
Sponsor Pharmacyclics LLC.
Collaborator Celgene Corporation
Start date May 2014
End date April 2017
Trial size 56 participants
Trial identifier NCT02142049, PCYC-1124-CA

Summary

This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL). This study is conducted in 2 parts where treatment will be administered in 3-week (21-day) cycles for 6 cycles. A standard 3+3 design will be employed in Part 1 to determine the maximum tolerated dose (MTD), which will then define the dose to be used in Part 2.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ibrutinib 560 mg PO + DA-EPOCH-R
ibrutinib, da-epoch-r Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
(Experimental)
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
ibrutinib, lenalidomide, da-epoch-r Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
(Experimental)
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
ibrutinib, lenalidomide, da-epoch-r Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
(Experimental)
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
ibrutinib, lenalidomide, da-epoch-r Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
(Experimental)
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
ibrutinib, lenalidomide, da-epoch-r Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Primary Outcomes

Measure
Number of Dose-Limiting Toxicities as a Measure of Safety and Tolerability
time frame: 1 year from first patient's first dose
Number of Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy
time frame: 1 year after last patient's first dose

Secondary Outcomes

Measure
Number of Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy
time frame: 1 year after first patient's first dose
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
time frame: 1 year after last patient's first dose
Duration of Response (DOR), Progression Free Survival (PRF) and Overall Survival (OS) as a Measure of Efficacy
time frame: 1 year after firs patient's last dose

Eligibility Criteria

Male or female participants at least 18 years old.

Major inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 - Pathologically confirmed relapsed/refractory DLBCL - Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension). - Adequate hepatic and renal function: - AST or ALT ≤2.5 x ULN - Serum Creatinine ≤ 2.0 mg/dL and creatinine clearance ≥60 mL/min/1.73 - Bilirubin ≤1.5 x ULN - Adequate hematologic function: - ANC >1,000 cells/mm3 - Platelets ≥75,000 cells/mm3 - Hemoglobin ≥8.0 g/dL - Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be ≤1.5 x the upper limit of the normal range (ULN) - Must be registered into the Revlimid REMS™program and be willing to comply with the requirements of Revlimid REMS™. Major Exclusion Criteria: - Known central nervous system lymphoma - Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks - Radio- or toxin-immunoconjugates within 10 weeks - Prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug

Additional Information

Official title A Multicenter Study of Ibrutinib and Lenalidomide in Combination With DA-EPOCH-R in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pharmacyclics LLC..