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Investigator(s):
Alan Wayne, M.D. Principal Investigator Phone: 301-496-4256 waynea@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin’s lymphoma (including lymphoblastic lymphoma, Burkitt’s lymphoma, and large cell lymphoma)
• Not amenable to available curative therapies
• Relapsed or refractory disease after at least 1 standard chemotherapy and 1 salvage regimen
• Measurable or evaluable disease
• Ineligible for or refused hematopoietic stem cell transplantation OR has disease activity that prohibits the time required to identify a suitable stem cell donor
• Prior CNS involvement allowed provided there is no current evidence of CNS malignancy
• No active CNS leukemia or lymphoma
• 6 months to 24 years of age
• Patients must have evidence of CD22 positivity
• No concurrent investigational therapies
• Patients must have recovered from acute toxic effects of all prior therapy
• ECOG 0-3 (for patients ≥ 12 years); Lansky ≥ 40 (for patients < 12 years)
• No active CNS leukemia or lymphoma
• No isolated testicular ALL
• No clinically significant unrelated systemic illness
• Patients whose serum neutralizes > 75% of the activity of 1 μg/mL of LMB-2 in tissue culture are excluded
• No HIV infection or active Hepatitis B or C

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Treatment Plan:

This is a non-randomized, dose-escalation study:

• Patients receive BL22 immunotoxin IV over 30 minutes every other day for 6 doses
• Courses* repeat every 21 days in the absence of disease progression or unacceptable toxicity
• Cohorts of 3–6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose (MTD) is determined
• Patients are followed weekly for at least 1 month and then every 1–3 months thereafter

Note: *Patients achieving a complete response or leukemia patients achieving a partial response with clearance of peripheral blasts may receive a lower dose of BL22 immunotoxin in subsequent courses repeating every 21 days

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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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/12/08
Updated: 8/31/06