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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00129155
• Other study ID #: 2003.332
• Status: Recruiting
• Phase: Phase 2
• First received: August 9, 2005
• Last updated: October 3, 2007
• Start date: February 2005

Study information

• Verified date: October 2007
• Source: Hospices Civils de Lyon
• Contact: Mauricette MICHALLET, MD
• Phone: 33 472 117 329
• Email: mauricette.michallet[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allogeneic Transplantation
• Hematological Malignancies
• Neoplasms

Intervention

Drug:
• treosulfan

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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