Status:
UNKNOWN
MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Hematological Malignancies
Allogeneic Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 unrelate...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00129155
Start Date
February 1 2005
Last Update
October 4 2007
Active Locations (1)
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1
Hôpital Edouard Herriot
Lyon, France, 69437