Trials / Recruiting
RecruitingNCT05807932
Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML
Phase-I/II Trial to Assess the Safety and Efficacy of Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML (FLAMSAClax
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- Heinrich-Heine University, Duesseldorf · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | Study treatment consists of the conditioning therapy including 6 or 8 days of Venetoclax treatment. |
| DRUG | Amsacrine | Amsacrine is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation |
| DRUG | Ara-C | Ara-C is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation |
| DRUG | Tacrolimus | Tacrolimus is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards. |
| DRUG | Mycophenolate Mofetil | Mycophenolate Mofetil is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards. |
Timeline
- Start date
- 2023-06-26
- Primary completion
- 2026-01-31
- Completion
- 2028-01-30
- First posted
- 2023-04-11
- Last updated
- 2024-05-01
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05807932. Inclusion in this directory is not an endorsement.