Status:
COMPLETED
Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
17-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Immunotoxins, such as anti-CD19 and anti-CD22, can find cancer cells that express CD19 and CD22 and kill them without harming normal cells. This may be an effective treatment for B-cell acu...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox) in patients with refractory or relapsed B-cell acute lymp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adult acute lymphoblastic leukemia
- B-cell lineage
- Refractory or relapsed disease based on a bone marrow/peripheral blood examination, cytogenetic studies, or polymerase chain reaction amplification
- Disease refractory to conventional therapy and other therapies of higher priority
- At least 50% of the blasts (in bone marrow or peripheral blood) expressing CD19 and/or CD22 by flow cytometry
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 2 months
- Creatinine \< 1.5 times normal
- Bilirubin \< 1.5 times normal
- ALT or AST \< 2.5 times normal
- PRIOR CONCURRENT THERAPY:
- Prior chemotherapy, biologic therapy, and/or radiotherapy allowed
Exclusion
Key Trial Info
Start Date :
February 22 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00450944
Start Date
February 22 2006
End Date
April 1 2010
Last Update
April 14 2021
Active Locations (1)
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1
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States, 10461