search
Back to results

Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CliniMACS (CD+3, CD+19 depletion)
CliniMACS (CD 34+ positive selection)
HSCT
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Diseases (ie, Leukemia, MDS, Lymphoma) focused on measuring Malignant and non-malignant diseases, Hematopoietic stem cell transplant, Peripheral blood progenitor cell transplant, CliniMACS device, T cell depletion

Eligibility Criteria

undefined - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stratum 1

Stratum 2

Arm Description

Patients receiving an unrelated donor or partially matched related donor.

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

Outcomes

Primary Outcome Measures

To measure the incidence and quality of engraftment

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2010
Last Updated
October 21, 2021
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital of Philadelphia
search

1. Study Identification

Unique Protocol Identification Number
NCT01071226
Brief Title
Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device
Official Title
CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
April 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Diseases (ie, Leukemia, MDS, Lymphoma), Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
Keywords
Malignant and non-malignant diseases, Hematopoietic stem cell transplant, Peripheral blood progenitor cell transplant, CliniMACS device, T cell depletion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1
Arm Type
Experimental
Arm Description
Patients receiving an unrelated donor or partially matched related donor.
Arm Title
Stratum 2
Arm Type
Experimental
Arm Description
For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
Intervention Type
Device
Intervention Name(s)
CliniMACS (CD+3, CD+19 depletion)
Intervention Description
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
Intervention Type
Device
Intervention Name(s)
CliniMACS (CD 34+ positive selection)
Intervention Description
Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection
Intervention Type
Other
Intervention Name(s)
HSCT
Intervention Description
Peripheral Blood Stem Cell Transplant
Primary Outcome Measure Information:
Title
To measure the incidence and quality of engraftment
Time Frame
Weekly for first 100 days, 6 months and 1 year
Secondary Outcome Measure Information:
Title
Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.
Time Frame
weekly for the first 100 days and then 6 and 12 months post transplant date

10. Eligibility

Sex
All
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All races are eligible Malignant diseases: Leukemias and Lymphomas Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A Talano, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

We'll reach out to this number within 24 hrs