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Impact of Remission Induction Chemotherapy Prior to Allogeneic SCT in Relapsed and Poor-response Patients With AML

NCT02461537 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2024-01-19

No results posted yet for this study

Summary

This trial compares outcome of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy. Patients will be randomized between two strategies. The standard strategy is aimed at achieving a complete remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, . The alternative is a less toxic disease-control strategy of disease monitoring and, if necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which should be performed as soon as possible.

Conditions

Interventions

DRUG

HAM

High-dose cytarabine 1 - 3 g/m2 (days 1-3)/Mitoxantrone 20 mg/m2 (days3-5)

DRUG

LDAC and/or Mitoxantrone

Low-dose cytarabine 20 mg/m2 (days 1-10) and/ or mitoxantrone 10mg/m2 (max 3 doses)

Sponsors & Collaborators

  • DKMS gemeinnützige GmbH

    lead OTHER

Principal Investigators

  • Johannes Schetelig, Prof Dr med · Universtitätsklinikum Dresden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-17
Primary Completion
2022-04-05
Completion
2024-01-12

Countries

  • Germany

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 NCT02461537 on ClinicalTrials.gov