MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT00129155

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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 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).

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancies Allogeneic Transplantation	Drug: treosulfan	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Study Start Date :

Feb 1, 2005

Outcome Measures

Primary Outcome Measures

Overall survival at 1 year []

Secondary Outcome Measures

Engraftment evaluation []
Acute and chronic graft-versus-host disease incidence and severity []
Response rate and survival without progression []
Evaluation of conditioning and transplant toxicity []
Chimerism evaluation []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)