Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT ID: NCT02142049
Last Updated: 2019-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2014-05-31
2017-08-31
Brief Summary
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Detailed Description
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Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses.
For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4).
The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Level 1
Ibrutinib 560 mg PO + DA-EPOCH-R
Ibrutinib
Ibrutinib
DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Part 1: Dose Level 2
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
Ibrutinib
Ibrutinib
DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomide
Lenalidomide
Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
Ibrutinib
Ibrutinib
DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomide
Lenalidomide
Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
Ibrutinib
Ibrutinib
DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomide
Lenalidomide
Part 2: RP2D
Recommended Phase 2 Dose(RP2D): Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
Ibrutinib
Ibrutinib
DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomide
Lenalidomide
Interventions
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Ibrutinib
Ibrutinib
DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Lenalidomide
Lenalidomide
Eligibility Criteria
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Inclusion Criteria
* 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™.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Jutta Neuenburg, MD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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SITE-1
Duarte, California, United States
SITE-2
Los Angeles, California, United States
SITE-10
Orange, California, United States
SITE-3
Chicago, Illinois, United States
SITE-5
Baltimore, Maryland, United States
SITE-6
Bethesda, Maryland, United States
SITE-4
Ann Arbor, Michigan, United States
SITE-8
Albuquerque, New Mexico, United States
SITE-9
Stony Brook, New York, United States
SITE-7
Charleston, South Carolina, United States
Countries
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References
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Wilson WH, Phillips T, Popplewell L, de Vos S, Chhabra S, Kimball AS, Beaupre D, Huang DW, Wright G, Kwei K, Ping J, Neuenburg JK, Staudt LM. Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2021 Sep;62(9):2094-2106. doi: 10.1080/10428194.2021.1907371. Epub 2021 Apr 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PCYC-1124-CA
Identifier Type: -
Identifier Source: org_study_id
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