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Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00450944
Recruitment Status : Recruiting
First Posted : March 22, 2007
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amit Verma, Albert Einstein College of Medicine

Study Description
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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 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 or disease Intervention/treatment Phase
Leukemia Biological: deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: 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
Study Start Date : November 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)
  2. Efficacy of treatment

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450944


Locations
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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   
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Study Chair: Amit Verma, MD Albert Einstein College of Medicine
More Information
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Responsible Party: Amit Verma, Professor, Oncology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00450944    
Obsolete Identifiers: NCT00272298
Other Study ID Numbers: 05-428
P30CA013330 ( U.S. NIH Grant/Contract )
AECM-CCI-2005-536
AECM-CCI-05-428
AECM-MMC-05-10-265C
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Amit Verma, Albert Einstein College of Medicine:
B-cell adult acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunotoxins
Immunologic Factors
Physiological Effects of Drugs