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10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1

NCT02252107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-03-19

No results posted yet for this study

Summary

This study examines whether the addition of decitabine to the standard Flu/TBI conditioning regimen prior to allogeneic stem cell transplantation in poor and very poor risk AML patients, reduces the risk of recurrence of the disease. Because decitabine has hardly any side effects, it will likely have little impact on the occurrence of Graft Versus Host Disease. The investigators are looking for a pre-treatment for transplantation which reduces the chance of recurrence of the disease without involving severe damage to normal tissues.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

decitabine

Single arm study: the addition of 10 days (20 mg/m2) decitabine to the conditioning regimen prior to allogeneic hematopoietic transplantation.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Gerwin Huls, MD. PhD. · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Belgium
  • Netherlands

Study Locations

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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 NCT02252107 on ClinicalTrials.gov