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Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome


Inclusion Criteria:



- Patients with high risk acute myeloid leukemia undergoing allogeneic transplantation
with either a familial or an unrelated donor.

High risk AML is defined as :

- AML in CR1 with unfavorable cytogenetics defined by complex caryotype, autosomal
monosomy combined or not with other cytogenetics abnormalities inv(3)/t(3,3), t(6;9),
t(6;11), t(11;19), del(5q), del(7q).

- AML in CR2 or greater remission prior allogeneic transplantation

- AML in PR or relapse prior allogeneic transplantation

- Or Patients with high risk myelodysplastic syndrome undergoing allogeneic
transplantation with either a familial or an unrelated donor.

High risk MDS is defined as :

- MDS with intermediate-2 group and higher risk group according to IPSS criteria

- Age 18 - 70 years.

- Availability of an HLA identical family donor or unrelated donor with matching in
10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR
family donor with maximum 1 allele mismatch.

- Conditioning regimen to allogeneic transplantation may be either myeloablative or
reduced.

- Be able to understand and sign informed consent.

- Affiliation number to National Health Care System

- Men and women of childbearing potential must use effective contraception during and
up to 3 months after treatment.

Exclusion Criteria:

- The presence of any one exclusion criteria renders the patient ineligible:

- Patient in full relapse post-transplant (>20% blasts in the bone marrow) following
allogeneic transplant

- Documented leukemic infiltration of CNS/cerebrospinal fluid.

- Karnofsky performance score below 60%.

- Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart
disease.

following allogeneic transplant

- Severe liver failure (bilirubin >30 μmoles/L, SGPT > 4 X upper limit of normal).

- Hepatic malignancy in advanced stage.

- Severe neurological or psychiatric disorders

- Acute GVHD grade II-III. Patient with grade I GVHD may be included (see annex 1 for
GHVD grade definition).

- Active uncontrolled infection.

- Denied informed consent.

- Treatment with other investigational drugs following allogeneic transplantation.

- No effective contraception

- Lactating females

- Pregnant woman

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the cumulative incidence of relapse rate

Outcome Description:

An A'Hern procedure will be used (cf. 11.1): If the number of patients not relapsed at two year will be 18 or more out of 24 patients, the null hypothesis will be rejected and the relapse rate will be considered acceptable.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Milpied Noel, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU BORDEAUX

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 10/07-H

NCT ID:

NCT01541280

Start Date:

November 2011

Completion Date:

November 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Allogreffe, LAM , MDS
  • Azacitidine (VidazaÒ)
  • Injection de lymphocytes de donneur (DLI)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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