A Phase I Study of Combination Therapy With Anti-CD19 and Anti-CD22 Immunotoxins (Combotox) in Adults With Refractory/Relapse Acute Lymphoblastic Leukemia
- 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 lymphoblastic leukemia.
- Determine the toxicity of Combotox in these patients.
- Determine the pharmacokinetic (PK) profile of Combotox in these patients.
- Determine any antitumor activity of Combotox, in terms of the percentage of blasts in
bone marrow and peripheral blood.
- Determine the levels of human antimouse and human anti-dgA antibodies in patients
treated with Combotox.
- Determine if there is a correlation between PK parameters and toxicity of Combotox in
- Determine if the expression of the CD19 and CD22 cell surface antigens is affected by
OUTLINE: This is a dose-escalation study.
Patients receive deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22
immunotoxins (Combotox) IV over 4 hours on days 1, 3, and 5 in the absence of disease
progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of Combotox until the maximum tolerated dose is
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)
Amit Verma, MD
Albert Einstein College of Medicine of Yeshiva University
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|