Trials / Completed
CompletedNCT02294552
Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Ivan S Moiseev · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in patients with different risk of GVHD. The risk-adapted strategy involves using single-agent cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem cells and mismatched bone marrow.
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Chronic Lymphocytic Leukemia
- Immune System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | |
| DRUG | Busulfan | |
| DRUG | Fludarabine monophosphate | |
| DRUG | Tacrolimus | |
| DRUG | Mycophenolate mofetil | |
| PROCEDURE | Allogeneic hematopoietic stem cell transplantation |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-11-01
- Completion
- 2017-11-01
- First posted
- 2014-11-19
- Last updated
- 2018-01-16
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT02294552. Inclusion in this directory is not an endorsement.