Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129155
Recruitment Status : Unknown
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : August 11, 2005
Last Update Posted : October 4, 2007
Sponsor:
Information provided by:
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE August 9, 2005
First Posted Date  ICMJE August 11, 2005
Last Update Posted Date October 4, 2007
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
Overall survival at 1 year
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Official Title  ICMJE Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hematological Malignancies
  • Allogeneic Transplantation
Intervention  ICMJE Drug: treosulfan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129155
Other Study ID Numbers  ICMJE 2003.332
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mauricette MICHALLET, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP