Combination Therapy for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byNitin Jain, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab together may work better in treating chronic lymphocytic leukemia.

Research Team

Nitin Jain, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with chronic lymphocytic leukemia who haven't had previous CLL treatments, have a certain type of gene mutation (mutated IGHV), and are in good physical condition (ECOG <=2). They must not be pregnant or breastfeeding, agree to use effective contraception, and cannot have other serious health issues like significant heart disease, uncontrolled infections, or bleeding disorders.

Inclusion Criteria

Patients or their legally authorized representative must provide written informed consent

Prothrombin time (PT)/international normalization ratio (INR) < 1.5 x ULN

Partial thromboplastin time (PTT) < 1.5 x ULN

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Exclusion Criteria

I haven't had major treatments or experimental therapy for my condition in the last 3 to 6 weeks.

Concurrent use of investigational therapeutic agent

I need treatment with a strong medication that affects liver enzymes.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating Agent)
Fludarabine Phosphate (Anti-metabolite)
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Obinutuzumab (Monoclonal Antibodies)

Trial OverviewThe study tests a combination of the drug ibrutinib with chemotherapy drugs fludarabine phosphate and cyclophosphamide plus the monoclonal antibody obinutuzumab. The goal is to see if this mix can better stop cancer cells from growing compared to current treatments by using both targeted therapy and immune system activation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (iFCG)Experimental Treatment4 Interventions

See Detailed Description.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: