drugset / Trial / NCT02999854
Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.
Timeline
- Start
- 2017-11-29
- Primary completion
- 2021-11-09
- Completion
- 2021-12-17
Outcome
Outcome not reported
Stopped: “Insufficient efficacy, terminated by Sponsor”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ATIR101 | Cell therapy | 2e+06 cells/kg | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |