Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01071226

Enrollment

Registered

2010-02-19

Start date

2008-05-31

Completion date

2020-04-28

Last updated

2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

DEVICECliniMACS (CD+3, CD+19 depletion)

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

DEVICECliniMACS (CD 34+ positive selection)

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

OTHERHSCT

Peripheral Blood Stem Cell Transplant

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 22 Years

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.

Design outcomes

Primary

Measure	Time frame
To measure the incidence and quality of engraftment	Weekly for first 100 days, 6 months and 1 year

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026