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Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML

NCT00669890 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-04-22

No results posted yet for this study

Summary

The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well tolerated.

This study will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (Part A)

Conditions

Interventions

DRUG

Gemtuzumab Ozogamicin

Dose Escalation

DRUG

Busulfan

Conditioning Regimen

DRUG

Cyclophosphamide

Conditioning Regimen

DRUG

Thymoglobulin

(Unrelated Donors only)

DRUG

Tacrolimus

GVHD Prophylaxis

DRUG

Mycophenolate Mofetil

GVHD Prophylaxis

DRUG

Methotrexate

GVHD Prophylaxis

Sponsors & Collaborators

  • New York Medical College

    lead OTHER

Principal Investigators

  • Mitchell S Cairo, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669890 on ClinicalTrials.gov