Rituximab + Chemotherapy for Hairy Cell Leukemia

Recruiting at 1 trial location

Overseen By Julie C Feurtado, R.N.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 16 weeks

69 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: * Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that has not responded well to or has recurred after standard HCL therapies. One nonstandard treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the immune system destroy them. By combining rituximab with other anti-cancer drugs, researchers hope to determine whether the combined drugs are successful in treating HCL. * Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat different kinds of blood and immune system cancers. Bendamustine is approved to treat other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin has been used for more than 20 years to treat HCL, but it has not been combined with rituximab in official clinical trials. Objectives: * To determine whether rituximab with either pentostatin or bendamustine is a more effective treatment for HCL than rituximab alone. * To determine whether pentostatin or bendamustine is a more effective treatment for HCL when combined with rituximab. Eligibility: - Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that has not responded well to or has relapsed after standard HCL therapies. Design: * The study will last for four treatment cycles of 28 days each. * Prior to the study, participants will be screened with a full medical history and physical exam, bone marrow biopsy (if one has not been performed in the last 6 months), computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as required by the researchers. Participants will provide blood and urine samples at this time as well. * Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles. * Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of each cycle and pentostatin on rituximab on Days 1 and 15 of each cycle, for a total of four cycles. * Participants will have regular tests during the treatment cycles, including bone marrow biopsies and CT or ultrasound scans. Participants will also provide regular blood and urine samples to assess the results of treatment.

Research Team

Robert J Kreitman, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults diagnosed with hairy cell leukemia that hasn't improved or has returned after standard treatments. They must have specific blood conditions, organ function within certain limits, and agree to birth control if applicable. Excluded are those with active infections, severe heart disease, HIV/hepatitis B/C, pregnant/nursing women, non-responsive to both drug combinations previously or unable to follow the trial procedures.

Inclusion Criteria

Patients who have eligible blood counts within 4 weeks from enrollment will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment

I need treatment for symptoms like frequent infections, low blood counts, or enlarged spleen.

My blood or lymph node test shows I have hairy cell leukemia.

Exclusion Criteria

I have an active infection that hasn't been treated.

I do not have severe heart disease.

I have been diagnosed with HIV, hepatitis B, or hepatitis C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive rituximab with either bendamustine or pentostatin for four 28-day cycles

16 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for disease progression and overall survival

4 years

Treatment Details

Interventions

• Bendamustine
• Pentostatin
• Rituximab

Trial Overview The trial is testing whether rituximab combined with either pentostatin or bendamustine is more effective for treating hairy cell leukemia than rituximab alone. Participants will undergo four treatment cycles of 28 days each and receive these drugs on specified days while their health is closely monitored through tests and biopsies.

Participant Groups

Group I: Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 with Rituximab Experimental Treatment 10 Interventions

After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab

Group II: Arm 2 - Non-randomized to 90 mg/m^2 Bendamustine-Rituximab Experimental Treatment 9 Interventions

Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed)

Group III: Arm 1 - Non-Randomized to 70 mg/m^2 Bendamustine-Rituximab Experimental Treatment 9 Interventions

Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed)

Group IV: Arm 3 - Randomized to 90 mg/m^2 Bendamustine-Rituximab Active Control 9 Interventions

Rituximab + Bendamustine (at the tolerated dose)

Group V: Arm 4 - Randomized to Pentostatin-Rituximab Active Control 9 Interventions

Rituximab + Pentostatin

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

Approved in United States as Treanda for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in European Union as Ribomustin for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma
• Multiple myeloma

Approved in Canada as Levact for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in Japan as Bendamustine hydrochloride for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+