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.
I. To evaluate safety and tolerability, and to determine the recommended phase II dose (RP2D)
and schedule of CD47 antagonist ALX148 (ALX148) in combination with rituximab and
lenalidomide in patients with relapsed or refractory B-non-Hodgkin lymphomas (NHLs) (both
indolent and aggressive histology) in phase I.
II. To evaluate the efficacy of the combination of ALX148, rituximab and lenalidomide at the
RP2D (determined in phase I) in patients with previously untreated and high tumor burden
indolent B-NHL in phase II.
I. To evaluate other toxicity and efficacy measures of the combination of ALX148, rituximab
I. To determine the pharmacodynamic effects and investigate biomarkers of response and
OUTLINE: This is a phase I, dose-escalation study of ALX148 followed by a phase II study.
Patients receive ALX148 intravenously (IV) over 1 hour once on days 1, 8, 15 and 22, or days
1 and 15, or day 1 depending on dose level. Patients also receive rituximab IV over 4-6 hours
on days 1, 8, 15 and 22 of cycle 1, then on day 1 of cycles 2-6, and lenalidomide orally (PO)
daily once (QD) on days 1-21 of cycles 1-6. Cycles repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 7 and 30 days, then up to 3
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.