Phase 2
Completed N=93
CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation for T and B Cell Depletion
Immunodeficiencies
Source: ClinicalTrials.gov NCT00579124 ↗
Enrolled (actual)
93
Serious AEs
8.6%
Results posted
Jan 2024
Primary outcomePrimary: Number of Participants With Successful Engraftment — 87; 5 Participants
Summary
This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD) in patients receiving unrelated or partially matched related donor peripheral stem cells using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility will be tested, focusing on engraftment, treatment-related mortality (with a specific focus on interstitial pneumonitis) and severe GVHD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Engraftment |
87; 5 | — |
Eligibility Criteria
Inclusion Criteria
As of October 2014 this study closed enrollment to malignant diseases. This study remains open to:
Non-malignant diseases:
- Bone marrow failure, including severe aplastic anemia
- Immunodeficiencies
Exclusion Criteria
- Patients who have had prior stem cell transplant (SCT) and bone marrow transplant (BMT) are excluded for study enrollment.
Data sourced from ClinicalTrials.gov (NCT00579124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.