Administration of 5-azacytidine and lymphocytes in patients in relapse after treatment by transplantation for a hematological cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005535-90-BE

Enrollment

Registered

2013-06-25

Start date

2013-12-09

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) in relapse after allogeneic stem cell transplantation MedDRA version: 18.0 Level: PT Classification code 10059034 Term: Acute myeloid leukaemia recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: HLT Classification c

Interventions

Trade Name: Vidaza Pharmaceutical Form: Lyophilisate for suspension for injection INN or Proposed INN: AZACITIDINE CAS Number: 320-67-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients : -Age = 18 years. -Be able to understand and sign informed consent. -Fertile patients must use a reliable contraception method. Disease status at transplantation : -Acute myelogenous leukemia (AML) in first or subsequent complete remission (=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: -More than 30% marrow blasts at the time of inclusion. -Extramedullary relapse including central nervous involvement. -ECOG Performance status > 2. -Active acute grade II-IV GvHD at the time of inclusion. -Active chronic GvHD requiring systemic therapy at the time of inclusion. -Uncontrolled infection. -HIV positive. -Acute or chronic heart failure (NYHA class III or IV) or symptomatic ischemic heart disease or ejection fraction 3 mg/dL, SGPT > 4 X upper normal limit). -Severe pulmonary failure (corrected DLCo < 35%). -Terminal renal failure requiring dialysis. -Severe neurological or psychiatric disorders. -Concurrent investigational drug. -Other treatment for relapse, except for hydroxyurea but it should be stopped before inclusion in the study. -Female who is pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the response rate to DLI by the combination with azacytidine in the population of patients with relapsed AML and MDS after allo-SCT. ; Secondary Objective: - To evaluate disease-free survival at 2 years. - To evaluate overall survival at 2 years. - To assess the toxicity profile (hematological and non-hematological). - To assess the incidence and severity of GvHD. - To assess the incidence and severity of infections. - To compare the study cohort to an historical group of patients with similar characteristics. ;Primary end point(s): The overall response rate to the combination of azacytidine and DLI will be defined by the addition of complete remission and partial remission.;Timepoint(s) of evaluation of this end point: Will be evaluated at day 24 of cycle 1, 3 and 5. Then every 3 months for a year after cycle 6 thereafter at 1.5 and 2 years after cycle 6.	—

Measure

Time frame

Main Objective: To assess the response rate to DLI by the combination with azacytidine in the population of patients with relapsed AML and MDS after allo-SCT. ; Secondary Objective: - To evaluate disease-free survival at 2 years. - To evaluate overall survival at 2 years. - To assess the toxicity profile (hematological and non-hematological). - To assess the incidence and severity of GvHD. - To assess the incidence and severity of infections. - To compare the study cohort to an historical group of patients with similar characteristics. ;Primary end point(s): The overall response rate to the combination of azacytidine and DLI will be defined by the addition of complete remission and partial remission.;Timepoint(s) of evaluation of this end point: Will be evaluated at day 24 of cycle 1, 3 and 5. Then every 3 months for a year after cycle 6 thereafter at 1.5 and 2 years after cycle 6.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1. At 2 years after cycle 6. 2. At 2 years after cycle 6. 3. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years. 4. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years. 5. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years. 6. At the end of the study. Sub-study 7. On day 1 of each cycle until cycle 6, then every 3 months for a year and at 1.5 and 2 years after cycle 6. 8. On day 1 of each cycle until cycle 6, then every 3 months for a year and at 1.5 and 2 years after cycle 6. ; Secondary end point(s): 1. Evaluation of disease-free survival. 2. Evaluation of overall survival. 3. Evaluation of haematological and non-haematological toxicities and safety of the planned therapy. 4. Incidence and severity of acute and chronic GvHD. 5. Incidence and severity of infections. 6. Compare the study cohort to an historical group of patients with similar characteristics. Sub-study 7. Influence of the therapy on immune reconstitution. 8. Influence of the therapy on Treg expansion.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1. At 2 years after cycle 6. 2. At 2 years after cycle 6. 3. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years. 4. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years. 5. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years. 6. At the end of the study. Sub-study 7. On day 1 of each cycle until cycle 6, then every 3 months for a year and at 1.5 and 2 years after cycle 6. 8. On day 1 of each cycle until cycle 6, then every 3 months for a year and at 1.5 and 2 years after cycle 6. ; Secondary end point(s): 1. Evaluation of disease-free survival. 2. Evaluation of overall survival. 3. Evaluation of haematological and non-haematological toxicities and safety of the planned therapy. 4. Incidence and severity of acute and chronic GvHD. 5. Incidence and severity of infections. 6. Compare the study cohort to an historical group of patients with similar characteristics. Sub-study 7. Influence of the therapy on immune reconstitution. 8. Influence of the therapy on Treg expansion.

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Countries

Belgium

Contacts

Public ContactPoiré Xavier

Cliniques Universitaires Saint-Luc

Xavier.Poire@uclouvain.be0032027641809

Outcome results

None listed

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