Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Inclusion Criteria:
- AGE: >= 18 years and <= 65 years
- Patients with a too high transplant-related mortality (TRM) after standard
transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma,
myelodysplasia)
- Patients with visceral contra-indication for standard transplantation:
- cardiac: myocardiopathy; forced expiratory volume (FEV) < 50%;
- respiratory: abnormal carbon monoxide diffusing capacity (DLCO);
- renal: creatinine clearance < 50ml/min;
- hepatic: transaminases and bilirubin > 2 upper normal limit;
- infectious: controlled fungal infection.
- Karnofsky score >= 70%
- Unrelated donor HLA identical (ABC, DRB1; DQB1)
- Signed informed consent
Diagnosis :
Chronic myelogenous leukemia (CML):
- In first chronic phase, resistant to interferon with or without aracytine or
refractory or resistant to Glivec
- In complete response (CR) or in 2nd partial response (PR) after being in blastic
phase
Multiple myeloma (MM):
- Relapse after autograft if the therapeutic response was evaluated to 50%
Non-Hodgkin's lymphoma (NHL):
- Mantle cell lymphoma after first relapse but in case of chemosensitivity ≥ 50% except
for high grade lymphoma
- In 2nd CR or PR chemosensitive in response ≥ 50% after autograft
Chronic lymphocytic leukemia (CLL):
- In 2nd CR or PR or in response ≥ 50% after autograft or in 2nd relapse after 2 lines
of treatment but in case of chemosensitivity ≥ 50%
Acute myeloid leukemia (AML):
- In 2nd CR or in 1st CR for high risk criteria [high risk criteria defined by: LAM 7;
leukocytes > 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23,
17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q]
Acute lymphoblastic leukemia (ALL):
- In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal
abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23
Myelodysplastic syndromes (MDS):
- Patients without prior chemotherapy, with intermediate or high International
Prognostic Scoring System (IPSS) score and blast cells < 1% in bone marrow (BM)
- CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM
- Secondary AML patients with a response to chemotherapy (< 30% blasts in BM and < 5%
of blast cells in blood)
For all:
- Adequate contraception in female patients of child bearing potential