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Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS

NCT00038831 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2012-08-01

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome.

Primary Objective:

1\. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation.

Secondary Objectives:

1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy.
2. To evaluate the incidence and severity of GVHD in this population
3. To evaluate disease-free and overall survival and relapse rates.

Conditions

Interventions

DRUG

Mylotarg

Starting dose 2 mg/m\^2 over 2-hour intravenous infusion on day -12.

DRUG

Fludarabine

30 mg/m\^2 will be given intravenously daily at the same time over 30 minutes on days -5, -4, -3, -2.

DRUG

Melphalan

140 mg/m\^2 will be given intravenously over 20 minutes starting 2 hours after the beginning of the fludarabine infusion on day -2.

DRUG

Anti-thymocyte globulin

Patients with an unrelated or mismatched related donor will receive 0.5 mg/kg on day -3 and 1.25 mg/Kg on days -2 and -1, following the chemotherapy.

PROCEDURE

Stem cell transplant

Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation: Infusion of blood stem cells or bone marrow cells on day 0.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Marcos De Lima, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2005-03-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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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 NCT00038831 on ClinicalTrials.gov