drugset / Trial / NCT02529852
A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma
Phase 1/2
Completed
59 enrolled
M.D. Anderson Cancer Center
Celgene Corporation · collabGenentech, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma. The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts.
Timeline
- Start
- 2015-11-04
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
Publications
- Results Cherng HJ, Alig SK, Oki Y, Nastoupil LJ, Fayad L, Neelapu SS, Turturro F, Hagemeister F, Craig AFM, Macaulay CW, Rodriguez MA, Lee HJ, McDonnell TJ, Flowers CR, Vega F, Green MR, Feng L, Kurtz DM, Alizadeh AA, Davis RE, Westin JR. A phase 1/2 study of lenalidomide and obinutuzumab with CHOP for newly diagnosed DLBCL. Blood Adv. 2023 Apr 11;7(7):1137-1145. doi: 10.1182/bloodadvances.2022008174.
- Roschewski M, Kurtz DM, Westin JR, Lynch RC, Gopal AK, Alig SK, Sworder BJ, Cherng HJ, Kuffer C, Blair D, Brown K, Goldstein JS, Schultz A, Close S, Chabon JJ, Diehn M, Wilson WH, Alizadeh AA. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec;43(34):3652-3661. doi: 10.1200/JCO-25-01534. Epub 2025 Aug 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |