Phase II Trial of LMB-2, Fludarabine, and Cyclophosphamide for Adult T-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:
- Diagnosis of acute or lymphomatous adult T-cell leukemia (ATL)
- Previously treated disease, unless the patient is ineligible for or refuses other protocols or treatment for ATL
- Neutralizing antibodies < 25% neutralization of 200 ng/mL of LMB-2 immunotoxin
- No central nervous system disease
- No prior therapy with LMB-2 immunotoxin
- No concurrent Coumadin
- ECOG performance status 0–2
- ANC ≥ 1,000/μL
- Platelet count ≥ 50,000/μL
- ALT and AST ≤ 2.5 x upper limits of normal
- Albumin ≥ 3 gm/dL
- Total bilirubin ≤ 1.5 mg/dL (< 5 mg/dL in patients with Gilbert syndrome)
- Creatinine < 2 mg/dL
- LVEF ≥ 45%
- DLCO or FEV1 ≥ 50% of normal
- No uncontrolled infection
- No untreated or uncontrolled second malignancy
- Not pregnant or nursing; fertile patients must use effective contraception prior to, during, and for 1 month after completion of study treatment
- No HIV or hepatitis C positivity; hepatitis B surface antigen positivity allowed provided patient is receiving lamivudine
This is a dose-escalation study of LMB-2 immunotoxin (LMB-2).
- Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV for 60 minutes on Days 1–3
- Beginning in Course 2, patients also receive LMB-2 IV over 30 minutes on Days 3, 5, and 7
- Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity
- Blood samples are collected 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.