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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00129155
First received: August 9, 2005
Last updated: October 3, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Hematological Malignancies
Allogeneic Transplantation
Drug: treosulfan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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

Estimated Enrollment: 30
Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129155

Contacts
Contact: Mauricette MICHALLET, MD 33 472 117 329 mauricette.michallet@chu-lyon.fr

Locations
France
Hôpital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Mauricette MICHALLET, MD    33 472 117 329    mauricette.michallet@chu-lyon.fr   
Principal Investigator: Mauricette Michallet, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Mauricette MICHALLET, MD Hospices Civils de Lyon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00129155     History of Changes
Other Study ID Numbers: 2003.332
Study First Received: August 9, 2005
Last Updated: October 3, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Allogenic stem cell transplantation
Treosulfan
Haematological malignancies
allogeneic stem cell transplantation in patients with hematological malignancies

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Treosulfan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014