Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
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Robert J. Kreitman, M.D.
Elizabeth Maestri, R.N.
Natasha Kormanik, R.N., B.S.N., O.C.N.
Joan Aaron, R.N., B.S.N., O.C.N.
Key Eligibility Criteria:
- 18 years of age or older
- Histologically confirmed diagnosis of hairy cell leukemia
- Treatment indicated based on demonstration of at least one of the following:
- Neutropenia (ANC < 1,000 cells/μL)
- Anemia (Hgb < 10 g/dL)
- Thrombocytopenia (Plt < 100,000/μL)
- Absolute lymphocyte count (ALC) > 5,000 cells/μL
- Symptomatic splenomegaly
- Enlarging lymph nodes > 2 cm
- Repeated infections requiring oral or IV antibiotics
- One of the following:
- At least two prior courses of purine analog
- One prior course of purine analog plus ≥ 1 course of rituximab if the response to the course of purine analog lasted < 1 year
- ECOG ≤ 3
- Recovered from previous treatment
- Creatinine < 1.5 mg/dL or creatinine clearance > 60 mL/min
- Bilirubin < 2 mg/dL unless consistent with Gilbert syndrome (total/direct > 5)
- ALT and AST < 2.5 x upper limit of normal
- No HIV, hepatitis B or C
- No uncontrolled coronary disease or NYHA class III-IV heart disease
- No CNS involvement
- No medical condition that would preclude study participation
- Not pregnant or lactating
A phase II clinical trial of rituximab with either pentostatin or bendamustine. All patients will be randomized (like flipping a coin) to receive rituximab with pentostatin or rituximab with bendamustine.
- Bendamustine IV infusion (through a vein) on Days 1–2 or pentostatin IV by rapid infusion on Days 1 and 15
- Rituximab IV infusion on Days 1 and 15
- Treatment repeats every 4 weeks
- Patients may receive up to 16 infusions of rituximab
- Periodic blood work and diagnostic scans are part of the clinical trial
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.