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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450944
• Other study ID #: 2005-536
• Secondary ID: P30CA013330AECM-
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2006
• Est. completion date: April 1, 2010

Study information

• Verified date: April 2021
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00272298

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 1, 2010
• Est. primary completion date: October 27, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins

Locations

Country	Name	City	State
United States	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)
Primary	Efficacy of treatment