NCT01188174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

4.4 years

First QC Date

August 11, 2010

Last Update Submit

December 4, 2014

Conditions

AML

Keywords

AMLprimary induction failure

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the survival rate at 2 years after transplantation

    at 2 years after transplantation

Study Arms (1)

Clofarabine

EXPERIMENTAL
Drug: Clofarabine

Interventions

ClofarabineDRUG

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.

Clofarabine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU de Bordeaux

Bordeaux, France

Location

CHU Caen

Caen, France

Location

CHRU lille

Lille, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Institut Paoli Calmette

Marseille, France

Location

Nantes University hospital

Nantes, 44200, France

Location

Paris saint Louis

Paris, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

  • Mohty M, Malard F, Blaise D, Milpied N, Socie G, Huynh A, Reman O, Yakoub-Agha I, Furst S, Guillaume T, Tabrizi R, Vigouroux S, Peterlin P, El-Cheikh J, Moreau P, Labopin M, Chevallier P. Sequential regimen of clofarabine, cytosine arabinoside and reduced-intensity conditioned transplantation for primary refractory acute myeloid leukemia. Haematologica. 2017 Jan;102(1):184-191. doi: 10.3324/haematol.2016.150326. Epub 2016 Aug 25.

    PMID: 27561720DERIVED

MeSH Terms

Interventions

Clofarabine

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesNucleotidesRibonucleotides

Study Officials

  • Mohamad Mohty, Phd

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 25, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

FR(9)