Trials / Recruiting
RecruitingNCT03802773
Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)
Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. All these findings support the use of alternative approaches for in vivo T cell depletion in the setting of CB transplantation.
Detailed description
Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a myeloablative conditioning regimen and a GVHD prophylaxis including post-transplant cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100 CD4+ cell count. Secondary endpoints are acute and chronic GVHD
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CB transplantation | Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies. |
Timeline
- Start date
- 2019-03-14
- Primary completion
- 2025-11-26
- Completion
- 2025-12-31
- First posted
- 2019-01-14
- Last updated
- 2025-04-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03802773. Inclusion in this directory is not an endorsement.