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Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL) (Cloric)

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ClinicalTrials.gov Identifier: NCT00863148
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:
Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in elderly patients. Thus, replacing Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity.The purpose of this study is to evaluate the efficacy and the safety of clofarabine in combination with IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or ALL not eligible to conventional or standard myeloablative allo-SCT.

Condition or disease Intervention/treatment Phase
MDS AML ALL BAL Drug: Clofarabine in combination with IV busulfan and ATG Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-label, Multicenter, Non Randomized Study Evaluating the Efficacy and the Safety of Clofarabine in Combination With IV Busulfan and Thymoglobulin (CBT) as a Reduced Intensity Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Adult Patients With High-risk AML, MDS or ALL.
Study Start Date : October 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Intervention Details:
  • Drug: Clofarabine in combination with IV busulfan and ATG
    A conservative approach has been used for the determination of the dose due to the high risk studied population, e.g., decrease to 30 mg m²/day for a 4-day course of clofarabine. Clofarabine will be started at Day -8 to allow improvement of liver function tests, if any, by time of allo-HSCT. Clofarabine (C) 30 mg/m²/day for 4 days (day -8 to day-5). Busilvex (B): 3.2 mg/kg/day for 2 days (day -4 and day-3)Thymoglobuline (T): 2.5 mg/Kg/day for 2 days (day -2 and day-1). Graft (G) at day 0 GVHD prophylaxis: Cyclosporine 3 mg/kg/day starting day-1. Genzyme provided supplies of clofarabine for all patients included in the study.

Outcome Measures
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Primary Outcome Measures :
  1. Relapse rate at one year after allo-SCT using the Clofarabine+Busulfan +Thymoglobuline reduced intensity conditioning regimen (CBT regimen). [ Time Frame: at one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 65
  • For patients younger than 50 years, cons-indication for the use of a standard myeloablative conditioning (history of hematopoietic stem cell transplantation autologous or allogeneic, or the presence of co-morbidities or medical history making prohibitive in terms toxicity using chemotherapy and / or high dose radiotherapy as judged by the referring physician) - MDS, ALL or AML at high risk, WHO THE biphenotypic-Score <2
  • Any primary diagnosis of high-risk MDS/AML or ALL eligible for a treatment by reduced intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (allo-SCT)
  • Suitable donor available (related or matched unrelated)
  • Cardiac: LV Ejection Fraction ≥ 50% by MUGA or Echocardiogram.
  • Pulmonary: FEV1 and FVC ≥ 50% predicted, and DLCO (corrected for hemoglobin) ≥ 50% of predicted
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%
  • Informed consent signed by patient prior to enrolment

Exclusion Criteria:

  • Age <18
  • Age >65
  • Known hypersensitivity to clofarabine or excipients- Other hematologic malignancies than ALL, AML and MDS
  • Patients with prior standard allogeneic HSCT with grade > 2 aGvHD
  • Prior standard allogeneic transplantation if < 2 months
  • Contra-indication to one of the drug of the RIC regimen .
  • Patient with > 3 treatment lines prior to inclusion
  • Pregnant or lactating females
  • Patient HIV+, Hep B+, Hep C+- Uncontrolled systemic infection
  • Performance Status Score ECOG > 2- Known central nervous system involvement with AML or ALL- Uncontrolled active infection of any kind or bleeding
  • Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen.
  • For patients younger than 50 years, possibly indicating a standard myeloablative conditioning
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863148


Locations
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France
Hôpital Edouard Herriot
Lyon, France, 69437
Institut Paoli Calmettes
Marseille, France, 13273
Nantes University hospital
Nantes, France, 44093
Hôpital Saint Louis
Paris, France, 75475
CHU Haut-Lévêque
Pessac, France, 33604
CHRU Hautepierre
Strasbourg, France, 67098
Sponsors and Collaborators
Nantes University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00863148    
Other Study ID Numbers: BRD/08/07-J
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Keywords provided by Nantes University Hospital:
MDS
AML
ALL
RIC
 clofarabine
allo-HSCT
high-risk MDS/AML
Additional relevant MeSH terms:
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Busulfan
Clofarabine
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites