| ID | Type | Description | Link |
|---|---|---|---|
| P30CA013330 | U.S. NIH Grant/Contract | View source | |
| AECM-CCI-2005-536 | |||
| AECM-CCI-05-428 | |||
| AECM-MMC-05-10-265C |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 acute lymphoblastic leukemia.
PURPOSE: This phase I trial is studying the side effects and best dose of anti-CD19 and anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute lymphoblastic leukemia.
OBJECTIVES:
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 determined.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy with Immunotoxins Imtox 19 Plus Imtox 22 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox) | ||
| Efficacy of treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed adult acute lymphoblastic leukemia
Refractory or relapsed disease based on a bone marrow/peripheral blood examination, cytogenetic studies, or polymerase chain reaction amplification
At least 50% of the blasts (in bone marrow or peripheral blood) expressing CD19 and/or CD22 by flow cytometry
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Verma, MD | Albert Einstein College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C577568 | combotox |
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