CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
CliniMACs devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02277639
NCT02277639Phase 2Completed
CompareCT.gov

Phase I/II Study of Reduced Intensity Conditioning for Patients With Non-Malignant Diseases Using CD3+/CD19+ Depleted Unrelated Donor or Partially Matched Related Donor Peripheral Stem Cells

Children's Hospital of Philadelphia·interventional·Posted Oct 29, 2014·Updated Apr 11, 2018

In Brief

A Phase 2 clinical trial evaluating CliniMACs device for Bone Marrow Failure Syndromes and 2 related conditions. Completed, enrolled 2 participants across 1 site.

Detailed Summary

This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell grafts from mismatched donors. There are two conditioning regimens depending upon patient diagnosis and age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Marrow Failure Syndromes, Immunodeficiencies, Immune Dysregulation Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2014
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.7 years ago

Interventions

CliniMACs devicedevice

Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells.