NCT02252107

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 19, 2020

Status Verified

October 1, 2018

Enrollment Period

4.6 years

First QC Date

September 19, 2014

Last Update Submit

March 18, 2020

Conditions

Acute Myeloid Leukemia (AML)

Keywords

DecitabineHematopoietic stem cell transplantation (HSCT)ConditioningAML

Outcome Measures

Primary Outcomes (1)

  • Relapse at 1-year after the transplantation procedure

    All patients included in this study are in complete morphologic remission. Relapse at 1-year is defined as the % of patients who have relapsed within the first year after transplantation. For the computation of the incidence of relapse at 1-year, death in CR will be considered as a competing risk.

    At 1-year after the transplantation procedure

Secondary Outcomes (3)

  • Relapse within the first 100 days after the transplantation procedure

    100 days after the transplantation procedure

  • Treatment related mortality (TRM) within the first 100 days after the transplantation procedure

    100 days after the transplantation procedure

  • Treatment related mortality (TRM) at 1-year after the transplantation procedure

    At 1-year after the transplantation procedure

Study Arms (1)

Decitabine

EXPERIMENTAL

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

Drug: decitabine

Interventions

decitabineDRUG

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

Also known as: Dacogen
Decitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible for allogeneic HCT, independent of age
  • Adult patients of any age with a cytopathologically confirmed diagnosis according to WHO classification of newly diagnosed AML (not APL = AML-M3), de novo AML or secondary AML
  • in first complete remission (CR1)
  • Poor risk or very poor risk subgroups
  • WHO performance status ≤ 2
  • Written informed consent

You may not qualify if:

  • Patient not in CR1
  • Patients who have senile dementia, mental impairment of any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
  • Active serious infections like HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Patient is unwilling to use contraceptive techniques during and for 12 months following treatment
  • Female patient who is pregnant or breastfeeding
  • Active and uncontrolled infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Liège

Liège, Belgium

Location

University Medical Center Groningen (UMCG)

Groningen, Netherlands

Location

Radboud university medical center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • Cruijsen M, Hilberink JR, van der Velden WJFM, Jansen JH, Bar B, Schaap NPM, de Haan A, Mulder AB, de Groot MR, Baron F, Vellenga E, Blijlevens NNM, Huls G. Low relapse risk in poor risk AML after conditioning with 10-day decitabine, fludarabine and 2 Gray TBI prior to allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2021 Aug;56(8):1964-1970. doi: 10.1038/s41409-021-01272-3. Epub 2021 Apr 6.

    PMID: 33824442DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Gerwin Huls, MD. PhD.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 29, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

March 19, 2020

Record last verified: 2018-10

Locations

BE(1)NL(2)