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