minimud study - unrelated reduced intensity conditioning with treosulfan® for allogeneic stem cell transplantation in patients with hematological malignancies

Conditions: Hematological Malignancies; Allogeneic Transplantation

Summary: in this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. the procedure and the follow-up are the same as in standard allogenic transplant. the donor is unrelated (identical hla). the graft is haematological peripheral blood stem cell. the conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).


Eligibility criteria:
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

Keywords: allogenic stem cell transplantation treosulfan haematological malignancies allogeneic stem cell transplantation in patients with hematological malignancies