NCT01071226

Brief Summary

T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

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

May 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

8.3 years

First QC Date

February 17, 2010

Last Update Submit

October 21, 2021

Conditions

Malignant Diseases (ie, Leukemia, MDS, Lymphoma)Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

Keywords

Malignant and non-malignant diseasesHematopoietic stem cell transplantPeripheral blood progenitor cell transplantCliniMACS deviceT cell depletion

Outcome Measures

Primary Outcomes (1)

  • To measure the incidence and quality of engraftment

    Weekly for first 100 days, 6 months and 1 year

Secondary Outcomes (1)

  • Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.

    weekly for the first 100 days and then 6 and 12 months post transplant date

Study Arms (2)

Stratum 1

EXPERIMENTAL

Patients receiving an unrelated donor or partially matched related donor.

Device: CliniMACS (CD+3, CD+19 depletion)Other: HSCT

Stratum 2

EXPERIMENTAL

For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1

Device: CliniMACS (CD 34+ positive selection)Other: HSCT

Interventions

CliniMACS (CD+3, CD+19 depletion)DEVICE

Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion

Stratum 1
CliniMACS (CD 34+ positive selection)DEVICE

Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection

Stratum 2
HSCTOTHER

Peripheral Blood Stem Cell Transplant

Stratum 1Stratum 2

Eligibility Criteria

AgeUp to 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All races are eligible
  • Malignant diseases: Leukemias and Lymphomas
  • Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies

You may not qualify if:

  • Lansky or Karnofsky \> 70
  • Echo \> 27% shortening fraction
  • renal function:serum creatinine \< 1.5 x for normal age
  • no active untreated infection
  • DLCO \> 50% of predicted value
  • Hepatic: AST and ALT \< 3x upper limit of normal; bilirubin \< 2.0.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaBone Marrow Failure Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow Diseases

Study Officials

  • Julie A Talano, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 19, 2010

Study Start

May 1, 2008

Primary Completion

August 1, 2016

Study Completion

April 28, 2020

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations

US(1)