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CompletedNCT00450944Updated Apr 14, 2021

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

A Phase 1 interventional study of deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins in Leukemia, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to participants aged 17 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-04-14.

Sponsored by Albert Einstein College of Medicine · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2008, 17 years 11 months ago, and no results have been posted to the registry.
  • Registered 1 year after the study started (first participant enrolled Feb 2006, registered Mar 2007).
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
17 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia

Keywords

  • B-cell adult acute lymphoblastic leukemia
  • recurrent adult acute lymphoblastic leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Combination Therapy with Immunotoxins Imtox 19 Plus Imtox 22

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

Interventions

  • Biologicaldeglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins
06

What researchers measure

Primary outcomes

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

  2. Efficacy of treatment

07

Study locations

1 site
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
    Bronx, New York 10461, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00450944
Lead sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 22, 2007
Start date
Feb 22, 2006
Primary completion
Oct 27, 2008
Completion
Apr 1, 2010
Last update
Apr 14, 2021

Study contacts

Amit Verma, MD
study chair · Albert Einstein College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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