Clinical trial · Interventional
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
NCT01071226CI-TRIAL-00054634completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Diseases (ie, Leukemia, MDS, Lymphoma) | — | UNRESOLVED | — |
| Non-malignant Diseases (ie, Bone Marrow Failure Syndromes) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS (CD 34+ positive selection) | Device | — | UNRESOLVED |
| CliniMACS (CD+3, CD+19 depletion) | Device | — | UNRESOLVED |
| HSCT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stratum 1
- description
- Patients receiving an unrelated donor or partially matched related donor.
- interventionNames
- Device: CliniMACS (CD+3, CD+19 depletion)
- Other: HSCT
- type
- EXPERIMENTAL
- label
- Stratum 2
- description
- For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
- interventionNames
- Device: CliniMACS (CD 34+ positive selection)
- Other: HSCT
Primary outcomes (1)
- measure
- To measure the incidence and quality of engraftment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.