Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia
NCT ID: NCT00450944
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2006-02-22
2010-04-01
Brief Summary
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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.
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Detailed Description
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* 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 these patients.
* Determine if the expression of the CD19 and CD22 cell surface antigens is affected by Combotox.
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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination Therapy with Immunotoxins Imtox 19 Plus Imtox 22
deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins
Interventions
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deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins
Eligibility Criteria
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Inclusion Criteria
* 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
17 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Amit Verma, MD
Role: STUDY_CHAIR
Albert Einstein College of Medicine
Locations
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Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
Countries
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Other Identifiers
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AECM-CCI-2005-536
Identifier Type: -
Identifier Source: secondary_id
AECM-CCI-05-428
Identifier Type: -
Identifier Source: secondary_id
AECM-MMC-05-10-265C
Identifier Type: -
Identifier Source: secondary_id
2005-536
Identifier Type: -
Identifier Source: org_study_id
NCT00272298
Identifier Type: -
Identifier Source: nct_alias
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