- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841724
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies (ITT 08-01)
May 15, 2012 updated by: Nantes University Hospital
Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Marseille, France, 13273
- Institut Paoli Calmettes
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Nantes, France, 44093
- CHU de Nantes
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Pessac, France, 33604
- CHU de Bordeaux
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients affiliated to a social security reimbursement system
- Adults (men or women) aged between 18 and 65 years
- Negative test for pregnancy
- ECOG 0-1 or Karnofsky Index ≥ 70%
- Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted)
- Life expectancy > 6 months
- Signed informed consent
- Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation
Exclusion Criteria:
- Pregnant woman or not willing to take effective contraception
- Classical contra-indications to the allogeneic stem cell transplantation procedure
- Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics
- Patients aged < 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen
- An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection
- History of uncontrolled psychiatric condition
- Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Busilvex, Fludara, Thymoglobuline
D-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation
Time Frame: 12 months after transplantation
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12 months after transplantation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the "classical" criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival
Time Frame: 12 months after transplantation
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12 months after transplantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamad Mohty, MD, PhD, CHU Nantes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 10, 2009
First Submitted That Met QC Criteria
February 10, 2009
First Posted (Estimate)
February 11, 2009
Study Record Updates
Last Update Posted (Estimate)
May 16, 2012
Last Update Submitted That Met QC Criteria
May 15, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Hematologic Diseases
- Neoplasms
- Hematologic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Fludarabine
- Busulfan
- Thymoglobulin
Other Study ID Numbers
- BRD 08/9-P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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