ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
NCT05025800 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2026-03-20
Summary
This phase I/II trial finds out the best dose, possible benefits and/or side effects of ALX148 in combination with rituximab and lenalidomide in treating patients with indolent and aggressive B-cell non-Hodgkin lymphoma. Immunotherapy with ALX148, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, 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. Rituximab is a monoclonal antibody that binds to a protein called CD20 found on B-cells, and may kill cancer cells. Giving ALX148 in combination with rituximab and lenalidomide may help to control the disease.
Conditions
- Aggressive B-Cell Non-Hodgkin Lymphoma
- Ann Arbor Stage III Grade 2 Follicular Lymphoma
- Ann Arbor Stage III Grade 3 Follicular Lymphoma
- Ann Arbor Stage III Marginal Zone Lymphoma
- Ann Arbor Stage IV Grade 1 Follicular Lymphoma
- Ann Arbor Stage IV Grade 2 Follicular Lymphoma
- Ann Arbor Stage IV Grade 3 Follicular Lymphoma
- Ann Arbor Stage IV Marginal Zone Lymphoma
- Composite Lymphoma
- Indolent B-Cell Non-Hodgkin Lymphoma
- Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
- Refractory Follicular Lymphoma
- Refractory Grade 3b Follicular Lymphoma
- Refractory High Grade B-Cell Lymphoma
- Refractory Mantle Cell Lymphoma
- Refractory Marginal Zone Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Refractory Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
- Richter Syndrome
Interventions
- DRUG
-
CD47 Antagonist ALX148
Given IV
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Paolo Strati, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-13
- Primary Completion
- 2028-03-21
- Completion
- 2028-03-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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