Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01059786
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Hairy Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pentostatin — DRUG
    28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle.
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles
  • Bendamustine — DRUG
    1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle
  • Acetaminophen — DRUG
    Treatment of infusion-related symptoms with acetaminophen is recommended.
  • Diphenhydramine — DRUG
    Treatment of infusion-related symptoms with diphenhydramine is recommended.
  • Epinephrine — DRUG
    Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.
  • Antihistamines — DRUG
    Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.
  • Corticosteroids — DRUG
    Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.
  • Bronchodilators — DRUG
    Additional treatment with bronchodilators may be indicated.
  • Intravenous (IV) Saline — OTHER
    Additional treatment with intravenous (IV) saline may be indicated.

Study Details

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.

Key Dates

Start date
Jul 1, 2010
Status verified
Jun 2025
Primary completion
Dec 15, 2022
Completion
Dec 31, 2027

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Non-Randomized to 70 mg/m^2 Bendamustine-Rituximab
    Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed)
  • Experimental: Arm 2 - Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
    Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed)
  • Active Comparator: Arm 3 - Randomized to 90 mg/m^2 Bendamustine-Rituximab
    Rituximab + Bendamustine (at the tolerated dose)
  • Active Comparator: Arm 4 - Randomized to Pentostatin-Rituximab
    Rituximab + Pentostatin
  • Experimental: Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 with Rituximab
    After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab

Primary Outcome Measure

Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) [ Time Frame: At end of treatment, approximately 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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