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

NCT00450944 | Completed Phase 1 DMC FDA Drug

• 5 other identifiers: 2005-536P30CA013330AECM-CCI-2005-536AECM-CCI-05-428AECM-MMC-05-10-265C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)

• Efficacy of treatment

Study Arms (1)

Combination Therapy with Immunotoxins Imtox 19 Plus Imtox 22

EXPERIMENTAL

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

Interventions

deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins BIOLOGICAL

Combination Therapy with Immunotoxins Imtox 19 Plus Imtox 22

Eligibility Criteria

• Age: 17 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

combotox

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Amit Verma, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: February 22, 2006
• Primary Completion: October 27, 2008
• Study Completion: April 1, 2010
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

US (1)