setric: Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01188174

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.

Condition or Disease	Intervention/Treatment	Phase
AML	Drug: Clofarabine	Phase 2

Detailed Description

Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment failure

Secondary Endpoints:

Feasibility of early transplantation within a multicenter trial
Leukemia-free survival (LFS) at 2 years from transplantation
Leukemia Response rate at day +30, +90 and 6 months
Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM)
Incidence and severity of acute and chronic Graft-versus-Host disease
Feasibility and safety of early discontinuation of immunosuppressive therapy

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clofarabine	Drug: Clofarabine The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.

Arm

Intervention/Treatment

Experimental: Clofarabine

Drug: Clofarabine

The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.

Outcome Measures

Primary Outcome Measures

Evaluation of the survival rate at 2 years after transplantation [at 2 years after transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leukemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease)
Age: 18-55 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.
Have adequate renal and hepatic functions as indicated by the following laboratory values:
Serum creatinine ≤1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female)
Serum bilirubin ≤1.5 mg/dL × upper limit of normal (ULN)
Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 × ULN
Alkaline phosphatase ≤2.5 × ULN

Exclusion Criteria:

Documented chloroma
Patients having AML M3
Documented leukemic infiltration of CNS/cerebrospinal fluid
Karnofsky performance score below < 60%
Acute or chronic heart failure
HIV infection, chronic viral hepatitis
Severe neurological or psychiatric disorders
Any circumstances that preclude the use of the drugs used within the protocol
Prior allogeneic or autologous stem cell transplantation
3 courses of prior chemotherapy
Denied informed consent
Pregnancy or denied of effective contraceptive method

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Bordeaux	Bordeaux	France
2	CHU Caen	Caen	France
3	CHRU lille	Lille	France
4	Hôpital Edouard Herriot	Lyon	France
5	Institut Paoli Calmette	Marseille	France
6	Nantes University hospital	Nantes	France	44200
7	Paris saint Louis	Paris	France
8	CHRU de Strasbourg	Strasbourg	France
9	CHU Toulouse	Toulouse	France

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: Mohamad Mohty, Phd, CHU Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01188174

Other Study ID Numbers:

BRD 09/6-C

First Posted:

Aug 25, 2010

Last Update Posted:

Dec 5, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Nantes University Hospital

AML

primary induction failure

Additional relevant MeSH terms:

Leukemia, Myeloid, Acute

Clofarabine

Study Results

No Results Posted as of Dec 5, 2014