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Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia

NCT00342316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2020-01-27

No results posted yet for this study

Summary

This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling or unrelated donor or with standard treatment, which is additional chemotherapy.

The study hypothesis is that the group transplanted with stem cells from a donor will have a superior survival compared with patients treated with standard of care.

Conditions

Interventions

PROCEDURE

Reduced Intensity Conditioning Stem Cell Transplantation

One of the following conditioning regimens: 1. Busulphan (orally or IV), fludarabine 2. Fludarabine, carmustine, melfalan 3. Cyclophosphamide, fludarabine

Sponsors & Collaborators

  • The Canadian Blood and Marrow Transplant Group

    collaborator NETWORK

  • Australasian Leukaemia and Lymphoma Group

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Mats Brune, MD, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
51 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-18
Primary Completion
2018-07-05
Completion
2018-07-20

Countries

  • Australia
  • Canada
  • Estonia
  • Finland
  • Germany
  • Greece
  • New Zealand
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT00342316 on ClinicalTrials.gov