Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00450944|
Recruitment Status : Recruiting
First Posted : March 22, 2007
Last Update Posted : September 6, 2019
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|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
- Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)
- Efficacy of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450944
|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 email@example.com|
|Study Chair:||Amit Verma, MD||Albert Einstein College of Medicine|