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Azacytidine and Lymphocytes in Relapse of AML or MDS After Allogeneic Stem Cell Transplantation.

NCT02017457 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-12-10

No results posted yet for this study

Summary

The present project is a multicenter, phase II trial which aims at evaluating if the administration of azacytidine (Vidaza®) combined to donor lymphocyte infusion (DLI) could improve the response rate to DLI in the population of patients with relapsed acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell transplantation.

Conditions

Interventions

BIOLOGICAL

Donor lymphocyte infusion

On day 1 of cycle 2, 4 and 6 of Azacytidine, patients will be infused with donor lymphocytes (ideally on day 1 but in case of organizational problems, DLI can be administered until day 5) . * Patients with a sibling donor will receive: * 5x10exp7 CD3+/kg on day 1 of cycle 2 * 5x10exp7 CD3+/kg on day 1 of cycle 4 * 10x10exp7 CD3+/kg on day 1 of cycle 6 * Patients with an unrelated donor will receive: * 1x10exp7 CD3+/kg on day 1 of cycle 2 * 5x10exp7 CD3+/kg on day 1 of cycle 4 * 10x10exp7 CD3+/kg on day 1 of cycle 6

DRUG

Azacytidine

* Cycle 1: Subcutaneous administration of 100mg/m2/day for 5 days. * Cycle 2: Subcutaneous administration of 35mg/m2/day for 5 days. Cycles will be administered every 28 days. All patients will receive at least 6 cycles of Azacytidine except if progression requests additional disease-related treatment such as hydroxyurea or other chemotherapeutic agents. In such cases, the patient will be excluded from the study and only disease status and survival status will be reported during the 3-year follow-up period. In case of complete remission after cycle 5, 2 additional cycles will be administered after achievement of complete remission. In case of stable disease or partial response, Azacytidine will be continued until progression. In case of disease progression after cycle 6, Azacytidine will be stopped.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Belgian Hematological Society

    collaborator OTHER

  • Carlos Graux, MD, PhD

    lead OTHER

Principal Investigators

  • Xavier Poiré, MD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  • Carlos Graux, MD, PhD · Cliniques Universitaires Mont-Godinne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Belgium

Study Locations

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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 NCT02017457 on ClinicalTrials.gov