NCT00693927

Brief Summary

Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
Last Updated

September 2, 2011

Status Verified

September 1, 2011

Enrollment Period

3.2 years

First QC Date

May 29, 2008

Last Update Submit

September 1, 2011

Conditions

Hematologic Malignancies

Keywords

Hematopoietic cell transplantationAllogeneicNonmyeloablativeCD8-depletionPBSCGVHDHematological malignancies and renal cell carcinoma

Outcome Measures

Primary Outcomes (2)

  • Incidence of acute GVHD in CD8-depleted versus unmanipulated groups

    180 days

  • Incidence of chronic GVHD (overall and extensive) in CD8-depleted versus unmanipulated groups.

    1-year

Secondary Outcomes (3)

  • Incidence of graft rejection [according to the risk of transplant rejection (see table 1 above)] in CD8-depleted versus unmanipulated groups.

    1-year

  • T cell (CD3) and myeloid (CD13) chimerism in CD8-depleted versus unmanipulated groups.

    1-year and then long term

  • Quality and timing of immune reconstitution in CD8-depleted versus unmanipulated groups.

    1-year

Study Arms (2)

1

ACTIVE COMPARATOR

Unmanipulated PBSC

Procedure: Unmanipulated PBSC after nonmyeloablative conditioning

2

EXPERIMENTAL

CD8-Depleted PBSC

Procedure: CD8-depleted PBSC after nonmyeloablative conditioning

Interventions

Unmanipulated PBSC after nonmyeloablative conditioningPROCEDURE

Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2). Unmanipulated PBSC from HLA-identical sibling or HLA-matched related or unrelated donor

1
CD8-depleted PBSC after nonmyeloablative conditioningPROCEDURE
Also known as: Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2)., CD8-depleted PBSC from HLA-identical sibling or HLA-matched related or unrelated donor
2

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female; female patients must use a reliable contraception method;
  • Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
  • HIV negative;
  • No terminal organ failure;
  • No uncontrolled infection, arrhythmia or hypertension;
  • Family donor (HLA-identical) or unrelated donor (matched for A-B by low resolution typing and for DRB1-DQB1 by high resolution typing);
  • No previous radiation therapy precluding the use of 2 Gy TBI
  • Informed consent given by patient or his/her guardian if of minor age.
  • Clinical situations
  • Theoretical disease indication for a standard allo-transplant, but not feasible because:
  • Age \> 55 yrs;
  • Unacceptable end organ performance;
  • Patient's refusal.
  • Indication for a standard auto-transplant:
  • perform mini-allotransplantation 2-6 months after standard autotransplant.
  • +8 more criteria

You may not qualify if:

  • Unable to undergo leukapheresis because of poor vein access or other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sart Tilman

Liège, Liege, B4000, Belgium

Location

MeSH Terms

Conditions

Hematologic NeoplasmsCarcinoma, Renal Cell

Interventions

Transplantation Conditioning

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Yves Beguin, MD, PhD

    University of Liege

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 9, 2008

Study Start

March 1, 2002

Primary Completion

May 1, 2005

Study Completion

May 1, 2008

Last Updated

September 2, 2011

Record last verified: 2011-09

Locations

BE(1)