NCT00841724

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

February 10, 2009

Last Update Submit

May 15, 2012

Conditions

Hematological Malignancies

Keywords

Allogeneic stem cell transplantationReduced-intensity conditioningReduced-toxicity conditioningHematological malignanciesIV Busulfan

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation

    12 months after transplantation

Secondary Outcomes (1)

  • 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

    12 months after transplantation

Study Arms (1)

Busilvex, Fludara, Thymoglobuline

ACTIVE COMPARATOR

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

Drug: Fludarabine, Busulfan, Thymoglobuline

Interventions

Fludarabine, Busulfan, ThymoglobulineDRUG
Busilvex, Fludara, Thymoglobuline

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabineBusulfanAntilymphocyte Serum

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsImmune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • Mohamad Mohty, MD, PhD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

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

February 10, 2009

First Posted

February 11, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

FR(3)