Skip to main content
OpenTrials
Completed

NCT Number: NCT01071226

Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Diseases (ie, Leukemia, MDS, Lymphoma) Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CliniMACS (CD+3, CD+19 depletion)

Device

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

CliniMACS (CD 34+ positive selection)

Device

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

HSCT

Other

Peripheral Blood Stem Cell Transplant

Primary outcomes

  1. To measure the incidence and quality of engraftment

    Time frame: 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.

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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion

Important dates

Study start
2008
Primary completion
2016
Study completion
2020
First posted
Feb 19, 2010
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.