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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)

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: MDS; AML; ALL; BAL

Intervention: Clofarabine in combination with IV busulfan and ATG (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Nantes University Hospital


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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Relapse rate at one year after allo-SCT using the Clofarabine+Busulfan +Thymoglobuline reduced intensity conditioning regimen (CBT regimen).


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


Locations and Contacts

Hôpital Edouard Herriot, Lyon 69437, France

Institut Paoli Calmettes, Marseille 13273, France

Nantes University hospital, Nantes 44093, France

Hôpital Saint Louis, Paris 75475, France

CHU Haut-Lévêque, Pessac 33604, France

CHRU Hautepierre, Strasbourg 67098, France

Additional Information

Starting date: October 2009
Last updated: September 19, 2013

Page last updated: August 23, 2015

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