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Investigator(s):
Robert J. Kreitman, M.D. Principal Investigator Phone: 301-496-6947 kreitmar@mail.nih.gov
Referral Contact(s):
Natasha Kormanik, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-496-9458 Fax: 301-451-5765 kormanikn@mail.nih.gov	Elizabeth Maestri, R.N. Research Nurse Phone: 301-402-5633 Fax: 301-451-5765 maestrie@mail.nih.gov	Joan  Aaron, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-1778 Fax: 301-451-5765 Aaronj@mail.nih.gov

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Key Eligibility Criteria:

• Diagnosis of hairy cell leukemia (HCL) confirmed by the following:
• Flow cytometry of blood, including positivity for CD19, CD22, CD20, and CD11c
• Bone marrow biopsy
• Requires treatment, as indicated by one of the following:
• Neutropenia (ANC < 1,000/μL)
• Anemia (hemoglobin < 10 g/dL)
• Thrombocytopenia (platelet count < 100,000/μL)
• Absolute lymphocyte count > 20,000/μL
• Symptomatic splenomegaly
• Enlarging lymph nodes > 2 cm
• Repeated infections requiring oral or IV antibiotics
• Patients with a documented history of no response to cladribine are not eligible
• No CNS disease
• No prior rituximab
• No prior purine analog therapy, other than 1 course of cladribine
• No other concurrent treatment, including radiotherapy, for HCL
• ≥ 18 years of age
• ECOG 0–3
• Bilirubin ≤ 2 mg/dL, unless consistent with Gilbert’s syndrome (total/direct bilirubin > 5 mg/dL)
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
• ALT and AST ≤ 2.5 x upper limit of normal
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 12 months after completion of study treatment
• No medical condition that would preclude study participation
• No known HIV or hepatitis B or C infection
• No active second malignancy requiring treatment
• Second malignancies with low activity that do not require treatment (e.g., low-grade prostate cancer or basal cell or squamous cell skin cancer) allowed

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Study Outline:

Patients are stratified according to prior treatment with cladribine (no vs yes). Patients are randomized to one of two treatment arms.

Arm I:


• Patients receive cladribine IV over 2 hours on Days 1–5 in Week 1 and rituximab IV once weekly for 8 weeks
• Beginning 6 months later, patients with minimal residual disease (MRD) receive a second course of rituximab once weekly for 8 weeks


Arm II


• Patients receive cladribine as in Arm I; beginning 6 months later, patients with MRD receive rituximab IV once weekly for 8 weeks

• In both arms, treatment continues in the absence of disease progression or unacceptable toxicity
• After completion of study therapy, patients are followed every 6 months

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Additional Information:

• 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.

Reviewed: 3/4/13
Updated: 2/7/13