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

Sponsor:	Albert Einstein College of Medicine of Yeshiva University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00450944

Purpose

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
Leukemia	Biological: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox) [ Designated as safety issue: No ]
Efficacy of treatment [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450944

Locations

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 of Yeshiva University

Investigators

Study Chair:

Amit Verma, MD

Albert Einstein College of Medicine of Yeshiva University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00450944 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

B-cell adult acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia

Additional relevant MeSH terms:

Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Tumor Virus Infections
Pharmacologic Actions
Immunotoxins
Neoplasms, Experimental
Herpesviridae Infections

Lymphoma, B-Cell
Virus Diseases
Lymphatic Diseases
Leukemia
Neoplasms
Burkitt Lymphoma
Epstein-Barr Virus Infections
DNA Virus Infections
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009