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Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia

NCT00002701 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2013-09-20

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.

Conditions

Interventions

DRUG

busulfan

DRUG

cyclophosphamide

DRUG

cytarabine

DRUG

etoposide

DRUG

idarubicin

DRUG

mercaptopurine

DRUG

methotrexate

DRUG

mitoxantrone hydrochloride

DRUG

thioguanine

DRUG

tretinoin

PROCEDURE

allogeneic bone marrow transplantation

PROCEDURE

autologous bone marrow transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Petra Muus, MD, PhD · Universitair Medisch Centrum St. Radboud - Nijmegen

  • Franco Mandelli, MD · Azienda Policlinico Umberto Primo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
16 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-10-31

Countries

  • Austria
  • Belgium
  • Croatia
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Turkey (Türkiye)

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 NCT00002701 on ClinicalTrials.gov