Phase II Study of LMB-2 Immunotoxin in Patients With Recurrent or Refractory CD25-Positive Hairy Cell Leukemia
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Robert J. Kreitman, M.D.
Natasha Kormanik, R.N., B.S.N., O.C.N.
Elizabeth Maestri, R.N.
Joan Aaron, R.N., B.S.N., O.C.N.
Key Eligibility Criteria:
- Histologically confirmed CD25-positive hairy cell leukemia
- Must have ≥ 1 of the following indications for treatment:
- Neutropenia (absolute neutrophil count < 1,000/mm³)
- Anemia (hemoglobin < 10 g/dL)
- Thrombocytopenia (platelet count < 100,000/mm³)
- Absolute lymphocyte count > 20,000 cells/mm³
- Symptomatic splenomegaly
- Received prior cladribine therapy
- Response lasted < 2 years after primary cladribine therapy
- Response lasted < 4 years after a repeat course of cladribine
- Received prior treatment with OR unable to receive BL22 recombinant immunotoxin
- Must have serum that neutralizes ≤ 75% of the activity of 1 μg/mL of LMB-2 immunotoxin using a bioassay
- More than 12 weeks since prior monoclonal antibody therapy; more than 4 weeks since prior systemic cytotoxic chemotherapy; more than 4 weeks since prior systemic steroids; no concurrent warfarin; no other concurrent investigational agents
- No prior LMB-2 immunotoxin
- ECOG performance status 0-2
- ALT and AST ≤ 5 times upper limit of normal (ULN), albumin ≥ 3.0 g/dL, bilirubin ≤ 2.2 mg/dL, creatinine ≤ 1.4 mg/dL OR creatinine clearance ≥ 50 mL/min
- LVEF ≥ 45%, DLCO ≥ 55% of normal, FEV1 ≥ 60% of normal
- HIV negative, hepatitis C negative, hepatitis B surface antigen positivity allowed provided patient is on lamivudine treatment
- No symptomatic congestive heart failure; no unstable angina pectoris; no cardiac arrhythmia
- No other active malignancy requiring systemic treatment; no other uncontrolled concurrent illness
This is a nonrandomized study.
- Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5
- Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
- Patients achieving a complete response (CR) may receive 2 additional courses beyond CR
- Patients achieving CR with minimal residual disease (MRD) may receive up to 4 additional courses beyond CR with MRD
- Patients who relapse after > 2 months of a CR or partial response may be eligible for retreatment
- Patients undergo blood collection periodically during study for pharmacokinetic studies
- After completion of study treatment, patients are followed periodically
- 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.