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Sponsored by: |
Albert Einstein College of Medicine of Yeshiva University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450944 |
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.
Condition | Intervention | Phase |
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Leukemia |
Drug: deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Combination Therapy With Anti-CD19 and Anti-CD22 Immunotoxins (Combotox) in Adults With Refractory/Relapse Acute Lymphoblastic Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | November 2005 |
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.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu |
Study Chair: | Amit Verma, MD | Albert Einstein College of Medicine of Yeshiva University |
Study ID Numbers: | CDR0000495296, AECM-CCI-2005-536, AECM-CCI-05-428, AECM-MMC-05-10-265C |
Study First Received: | March 20, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00450944 |
Health Authority: | Unspecified |
B-cell adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia |
Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunotoxins Recurrence Acute lymphoblastic leukemia, adult Herpesviridae Infections Virus Diseases Lymphoma, B-Cell Burkitt's lymphoma |
Lymphatic Diseases Leukemia B-cell lymphomas Burkitt Lymphoma Epstein-Barr Virus Infections DNA Virus Infections Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Tumor Virus Infections Pharmacologic Actions Neoplasms, Experimental |