Decitabine in the conditioning strategy for AML

10-day decitabine, fludarabine and 2 Gray TBI as conditioning strategy for poor and very poor risk AML in CR1 - Decitabine in the conditioning strategy for AML. PLMA34 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000400-99-NL

Enrollment

Registered

2014-06-20

Start date

2014-09-15

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia AML MedDRA version: 17.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864

Interventions

Trade Name: Dacogen Product Name: Dacogen Product Code: EMEA/H/C/002221 Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Patients eligible for allogeneic HCT, independent of age • 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 Poor risk is defined as: - Normal karyotype, WBC = 100, not in CR after first cycle of chemo - Normal karyotype, WBC > 100 - Abnormal karyotype, non CBF, MK, no abn 3q26, EVI1- Very poor risk is defined as: - Non CBF, MK+ - Non CBF, abn eq26 - Non CBF, EVI1+ - Non CBF, high Flt3-ITD allelic burden CBF = Core Binding Factor MK = monosomal karyotype Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Exclusion criteria • 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, HBV and HCV • Patient is unwilling to use contraceptive techniques during and for 12 months following treatment • Female patient who is pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT in poor and very poor risk AML patients in CR1. Safety will be assessed by adverse events and laboratory parameters; efficacy will be assessed by (decrease of) relapse rate at 15 months (fixed time point) after last-patient-in.;Secondary Objective: The secondary objectives of this study are: 1. To assess the safety profile: i.e. treatment related mortality (TRM) of the transplantation procedure and toxicity, associated with this conditioning regimen. 2. To assess transplant related parameters: i.e. acute and chronic graft-versus-host disease (GVHD), rejection, engraftment kinetics (T-cell and bone marrow chimerisms). 3. To assess the efficacy profile: i.e. relapse frequency after allogeneic HCT, overall survival (OS), disease free survival (DFS) and event free survival (EFS) 4. To assess the social/economic impact both therapy regimens: i.e. Quality of Life (QoL) (EORTCQ30; t=0 and follow up), days staying in the hospital and transfusion needs. 5. To assess the impact of this conditioning regimen on mucositis (citrulline levels as biomarker of intestinal mucositis) and conditioning-induced inflammation (soluble TNFR1, IL-8 and C-reactive protein levels).;Primary end point(s): • Primary endpoints • Relapse at 1-year after the transplantation procedure • TRM at 1-year after the transplantation procedure ;Timepoint(s) of evaluation of this end point: See before, this is defined in the endpoints	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT in poor and very poor risk AML patients in CR1. Safety will be assessed by adverse events and laboratory parameters; efficacy will be assessed by (decrease of) relapse rate at 15 months (fixed time point) after last-patient-in.;Secondary Objective: The secondary objectives of this study are: 1. To assess the safety profile: i.e. treatment related mortality (TRM) of the transplantation procedure and toxicity, associated with this conditioning regimen. 2. To assess transplant related parameters: i.e. acute and chronic graft-versus-host disease (GVHD), rejection, engraftment kinetics (T-cell and bone marrow chimerisms). 3. To assess the efficacy profile: i.e. relapse frequency after allogeneic HCT, overall survival (OS), disease free survival (DFS) and event free survival (EFS) 4. To assess the social/economic impact both therapy regimens: i.e. Quality of Life (QoL) (EORTCQ30; t=0 and follow up), days staying in the hospital and transfusion needs. 5. To assess the impact of this conditioning regimen on mucositis (citrulline levels as biomarker of intestinal mucositis) and conditioning-induced inflammation (soluble TNFR1, IL-8 and C-reactive protein levels).;Primary end point(s): • Primary endpoints • Relapse at 1-year after the transplantation procedure • TRM at 1-year after the transplantation procedure ;Timepoint(s) of evaluation of this end point: See before, this is defined in the endpoints

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Secondary

Measure	Time frame
Secondary end point(s): • Secondary endpoints • Relapse within the first 100 days after the transplantation procedure • TRM within the first 100 days after the transplantation procedure • Grade II-IV and grade III-IV acute GVHD within the first year after the transplantation procedure • Chronic GVHD at 1 year after the transplantation procedure • Rejection within the first year after the transplantation procedure • Overall survival (OS) (based on intention to treat analysis) • Disease free survival (DFS), event free survival (EFS) • Cumulative incidence of relapse • Days of staying in hospital and transfusion needs • Evolution of donor T cell chimerism levels • TNFR1 and citrulline increment from the start of the conditioning regimen to day 7 after transplantation? ;Timepoint(s) of evaluation of this end point: See before, this is defined in the endpoints	—

Measure

Time frame

Secondary end point(s): • Secondary endpoints • Relapse within the first 100 days after the transplantation procedure • TRM within the first 100 days after the transplantation procedure • Grade II-IV and grade III-IV acute GVHD within the first year after the transplantation procedure • Chronic GVHD at 1 year after the transplantation procedure • Rejection within the first year after the transplantation procedure • Overall survival (OS) (based on intention to treat analysis) • Disease free survival (DFS), event free survival (EFS) • Cumulative incidence of relapse • Days of staying in hospital and transfusion needs • Evolution of donor T cell chimerism levels • TNFR1 and citrulline increment from the start of the conditioning regimen to day 7 after transplantation? ;Timepoint(s) of evaluation of this end point: See before, this is defined in the endpoints

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Countries

Belgium, Netherlands

Contacts

Public ContactAfdeling Hematologie Trialcoördinat

Radboud university medical center

Datacentrum@HEMAT.umcn.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026