Ibrutinib with or without Cirmtuzumab in Treating Patients with B-Cell Lymphoid Malignancies

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT03088878
Trial Phases:	Phase I Phase II	Protocol IDs:	170127 (primary) NCI-2018-01703 NCT03420183
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	UC San Diego Medical Center - Hillcrest
NCI Full Details:	http://clinicaltrials.gov/show/NCT03088878

Summary

This phase Ib/II trial studies the side effects and best dose of cirmtuzumab when given together with ibrutinib and to see how well they work in treating patients with B-cell lymphoid malignancies. Immunotherapy with cirmtuzumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving ibrutinib with or without cirmtuzumab may work better in treating patients with B-cell lymphoid malignancies.

Objectives

PRIMARY OBJECTIVES:
I. To determine the recommended dosing regimen (RDR) of cirmtuzumab when given alone and in combination with ibrutinib in subjects with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL). (Part 1 [cirmtuzumab ? cirmtuzumab + ibrutinib])
II. To further characterize the safety and pharmacology of cirmtuzumab/ibrutinib when administered using the RDR. (Part 2 [cirmtuzumab + ibrutinib])
III. To evaluate the complete response (CR) rate associated with cirmtuzumab/ibrutinib when administered using the RDR. (Part 3 [cirmtuzumab + ibrutinib versus ibrutinib])

SECONDARY OBJECTIVES:
I. To determine the drug administration, safety, and supportive care profiles of cirmtuzumab and the combination of cirmtuzumab/ibrutinib.
II. To evaluate the pharmacokinetic profile of cirmtuzumab alone and in combination with ibrutinib.
III. To assess the effects of cirmtuzumab and cirmtuzumab/ibrutinib on pharmacodynamic markers relating to drug mechanism, immune profile, and disease manifestations.
IV. To characterize the immunogenicity of cirmtuzumab.
V. To characterize the antitumor activity of cirmtuzumab monotherapy and cirmtuzumab/ibrutinib combination therapy.

OUTLINE: This is a phase Ib, dose-escalation study of cirmtuzumab followed by a phase II study. Patients are randomized to 1 of 2 arms.

ARM I: Patients receive cirmtuzumab intravenously (IV) over 30-90 minutes every 2 weeks for 3 doses (weeks 0, 2, and 4) and then every 4 weeks on weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48. Patients also receive ibrutinib orally (PO) once daily (QD) starting week 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 30 days, and then every 3 or 6 months for up to 5 years.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.