NCT00129155

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
Last Updated

October 4, 2007

Status Verified

October 1, 2007

First QC Date

August 9, 2005

Last Update Submit

October 3, 2007

Conditions

Hematological MalignanciesAllogeneic Transplantation

Keywords

Allogenic stem cell transplantationTreosulfanHaematological malignanciesallogeneic stem cell transplantation in patients with hematological malignancies

Outcome Measures

Primary Outcomes (1)

  • Overall survival at 1 year

Secondary Outcomes (5)

  • 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

Interventions

treosulfanDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69437, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

treosulfan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mauricette MICHALLET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauricette MICHALLET, MD

CONTACT

33 472 117 329mauricette.michallet@chu-lyon.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

February 1, 2005

Last Updated

October 4, 2007

Record last verified: 2007-10

Locations

FR(1)