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

NCT ID: NCT00129155

Last Updated: 2007-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28

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).

Conditions

Hematological Malignancies; Allogeneic Transplantation

Keywords

Allogenic stem cell transplantation; Treosulfan; Haematological malignancies; allogeneic stem cell transplantation in patients with hematological malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

treosulfan

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Principal Investigators

Mauricette MICHALLET, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Edouard Herriot

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mauricette MICHALLET, MD

Role: CONTACT

Phone: 33 472 117 329

Email: mauricette.michallet@chu-lyon.fr

Facility Contacts

Mauricette MICHALLET, MD

Role: primary

Other Identifiers

2003.332

Identifier Type: -

Identifier Source: org_study_id