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

Primary Purpose

Hematological Malignancies, Allogeneic Transplantation

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
treosulfan
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies focused on measuring Allogenic stem cell transplantation, Treosulfan, Haematological malignancies, allogeneic stem cell transplantation in patients with hematological malignancies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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) For all: Adequate contraception in female patients of child bearing potential

Sites / Locations

  • Hôpital Edouard HerriotRecruiting

Outcomes

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

Full Information

First Posted
August 9, 2005
Last Updated
October 3, 2007
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00129155
Brief Title
MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Official Title
Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies, Allogeneic Transplantation
Keywords
Allogenic stem cell transplantation, Treosulfan, Haematological malignancies, allogeneic stem cell transplantation in patients with hematological malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
treosulfan
Primary Outcome Measure Information:
Title
Overall survival at 1 year
Secondary Outcome Measure Information:
Title
Engraftment evaluation
Title
Acute and chronic graft-versus-host disease incidence and severity
Title
Response rate and survival without progression
Title
Evaluation of conditioning and transplant toxicity
Title
Chimerism evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricette MICHALLET, MD
Phone
33 472 117 329
Email
mauricette.michallet@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricette MICHALLET, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauricette MICHALLET, MD
Phone
33 472 117 329
Email
mauricette.michallet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Mauricette Michallet, MD

12. IPD Sharing Statement

Learn more about this trial

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

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