CTIS2024-514688-24-00
Recruiting
Phase 1
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
Heinrich-Heine-Universitaet Duesseldorf0 sites38 target enrollmentJuly 9, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Heinrich-Heine-Universitaet Duesseldorf
- Enrollment
- 38
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •MDS, CMML or sAML according to WHO classification (revised version 2016\) with a marrow blast count \>5% and/or high\-risk genetic features (eg. bad risk karyotype according to the IPSS\-R / ELN classification or presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK\-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT), falling into the high or very high risk category of the IPSS\-R or IPSS M) any time between diagnosis and inclusion.
Exclusion Criteria
- •previous cytotoxic therapy exceeding oral Hydroxyurea or \>2 courses of treatment with Azacytidine, Decitabine or low dose Ara\-C alone or in combination with Venetoclax
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1/2
Trial evaluating the safety and efficacy of Venetoclax in addition to a standard conditioning regime in patients with certain forms of leukemia undergoing allogeneic blood stem cell transplantation2024-514688-24-00Heinrich-Heine-Universitaet Duesseldorf38
Active, not recruiting
Phase 1
Trial to evaluate the safety and efficacy of a new drug in combination with the standard therapy to prevent the rejection which could occur after a transplantation.Adult patiens after allogeneic stem cell transplantationMedDRA version: 19.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 100000004870MedDRA version: 19.1Level: LLTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2016-002503-26-ESFundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)152
Not yet recruiting
Phase 1
CIGB-Mambisa/Abdala in convalescentsCOVID-19 ConvalescenceCOVID-19SARS-CoV2Coronavirus InfectionsSARS VirusCoronaviridae InfectionsBetacoronavirusRPCEC00000382Center for Genetic Engineering and Biotechnology (CIGB)120
Active, not recruiting
Phase 1
Safety assessment and dose of fibrin sealant derived from snake venom in the treatment of wounds.RBR-9mbdj3Faculdade de Medicina de Botucatu - Unesp
Recruiting
Phase 1
Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patientsCastration resistant prostate cancerJPRN-UMIN000006142Department of Urology, Osaka University Graduate School of Medicine12