NCT02992522

Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Active, enrolled Phase 1 Last updated 9 September 2025

What this trial tests

Phase 1 trial testing Lenalidomide in B-Cell Lymphoma, Unspecified in 22 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 February 2017

Primary endpoint
15 August 2026

15 August 2026

Quick facts

Lead sponsor	Beth Christian
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	21 February 2017
Primary completion	15 August 2026
Estimated completion	15 August 2026
Sites	2 locations across United States

Drugs / interventions tested

• Lenalidomide — full drug profile →
• Obinutuzumab — full drug profile →
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• B-Cell Lymphoma, Unspecified — all drugs for B-Cell Lymphoma, Unspecified →
• Grade 1 Follicular Lymphoma — all drugs for Grade 1 Follicular Lymphoma →
• Grade 2 Follicular Lymphoma — all drugs for Grade 2 Follicular Lymphoma →
• Grade 3a Follicular Lymphoma — all drugs for Grade 3a Follicular Lymphoma →

Sponsor

Beth Christian — full company profile →

Who can join

18 and older, any sex, with B-Cell Lymphoma, Unspecified or Grade 1 Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I study studies the side effects and best dose of venetoclax and lenalidomide when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or not responding to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pathways and mechanisms of venetoclax resistance.
   Bose P, Gandhi V, Konopleva M. · · 2017 · cited 223× · PMID 28140720 · DOI 10.1080/10428194.2017.1283032
2. BCL-2 as therapeutic target for hematological malignancies.
   Perini GF, Ribeiro GN, Pinto Neto JV, Campos LT, et al · · 2018 · cited 153× · PMID 29747654 · DOI 10.1186/s13045-018-0608-2
3. New agents and regimens for diffuse large B cell lymphoma.
   Wang L, Li LR, Young KH. · · 2020 · cited 109× · PMID 33317571 · DOI 10.1186/s13045-020-01011-z
4. Dysregulation of Cell Survival in Diffuse Large B Cell Lymphoma: Mechanisms and Therapeutic Targets.
   Miao Y, Medeiros LJ, Xu-Monette ZY, Li J, et al · · 2019 · cited 39× · PMID 30881917 · DOI 10.3389/fonc.2019.00107
5. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies.
   Sawalha Y. · · 2021 · cited 25× · PMID 34945817 · DOI 10.3390/jpm11121345
6. Development of venetoclax for therapy of lymphoid malignancies.
   Zhu H, Almasan A. · · 2017 · cited 21× · PMID 28331288 · DOI 10.2147/dddt.s109325
7. The progress of novel strategies on immune-based therapy in relapsed or refractory diffuse large B-cell lymphoma.
   Lu T, Zhang J, Xu-Monette ZY, Young KH. · · 2023 · cited 19× · PMID 37580826 · DOI 10.1186/s40164-023-00432-z
8. Novel Targets and Advanced Therapies in Diffuse Large B Cell Lymphomas.
   D'Alò F, Bellesi S, Maiolo E, Alma E, et al · · 2024 · cited 18× · PMID 38927948 · DOI 10.3390/cancers16122243