Hematological Malignancies Clinical Trial
Official title:
Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
NCT number | NCT00129155 |
Other study ID # | 2003.332 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | August 9, 2005 |
Last updated | October 3, 2007 |
Start date | February 2005 |
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Edouard Herriot | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival at 1 year | |||
Secondary | Engraftment evaluation | |||
Secondary | Acute and chronic graft-versus-host disease incidence and severity | |||
Secondary | Response rate and survival without progression | |||
Secondary | Evaluation of conditioning and transplant toxicity | |||
Secondary | Chimerism evaluation |
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