Ibrutinib + Rituximab for Chronic Lymphocytic Leukemia

Recruiting at 877 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Research Team

Tait D Shanafelt

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Participants should have symptoms like night sweats, weight loss, or anemia and meet specific blood criteria. They must not have had prior treatments for CLL/SLL, active infections, other primary cancers requiring treatment within 2 years, or certain heart conditions.

Inclusion Criteria

I have been diagnosed with CLL or SLL.

I have a confirmed diagnosis of small lymphocytic lymphoma or CLL.

I meet the criteria for needing treatment.

Exclusion Criteria

Recent vaccination history

I need certain medications or treatments.

I have a specific condition affecting my digestive system.

Treatment Details

Interventions

• Cyclophosphamide (Alkylating agents)
• Fludarabine Phosphate (Anti-metabolites)
• Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
• Rituximab (Monoclonal Antibodies)

Trial Overview The study compares the effectiveness of Ibrutinib plus Rituximab against Fludarabine Phosphate with Cyclophosphamide and Rituximab in treating CLL/SLL. It aims to determine which combination works better at stopping cancer cell growth by either killing cells or helping the immune system attack them.

Participant Groups

Group I: Arm A (ibrutinib, rituximab) Experimental Treatment 5 Interventions

Patients receive ibrutinib PO QD on days 1-28. Beginning cycle 2, patients also receive rituximab IV over 4 hours on days 1 and 2 of cycle 2, and day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.

Group II: Arm B (rituximab, fludarabine phosphate, cyclophosphamide) Active Control 6 Interventions

Patients receive rituximab IV over 4 hours on days 1 and 2 of cycle 1, and day 1 of cycles 2-6. Patients also receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+