Clinical trial · Interventional
Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT) toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid leukaemia.UCBT related mortality and morbidity were limiting factors for the development of this procedure in adults. Non myeloablative conditioning regimen showed promising results and prospective evaluation has to be developed to confirm these retrospective data.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cord blood transplantation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Umbilical cord blood transplantation after reduced intensity conditioning
- interventionNames
- Other: Cord blood transplantation
Primary outcomes (1)
- measure
- Transplant related mortality
- timeFrame
- At 2 years
Secondary outcomes (1)
- measure
- Clinical efficiency (overall survival, event free survival, relapse incidence, acute and chronic GVHD incidence, graft failure, venoocclusive disease, interstitial pneumonia, infections, comorbidity score, quality of life and medico-economic impact)
- timeFrame
- at 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Ages : 4 to 65 * De novo or secondary AML requiring allogeneic transplant * No donor (related or unrelated) compatible 10/10 * Complete remission excepted CR1 with t(8;21) or inv (16) or t (15;17) * Smouldering AML without progression * Signed assent of recipient Exclusion Criteria: * If CR1: AML with with t(8;21) or inv (16) or t (15;17) * Karnofsky \< 50% - Clearance of creatinin \< 40 ml/min * Transaminases \> 8 N * Previous autologous or allogeneic transplantation within 6 month prior to the study (except if tandem) * total body irradiation contra-indicating 2 Gy TBI * local irradiation contra-indicating 2 Gy TBI
References
Publications (1)
- DERIVEDRio B, Chevret S, Vigouroux S, Chevallier P, Furst S, Sirvent A, Bay JO, Socie G, Ceballos P, Huynh A, Cornillon J, Francoise S, Legrand F, Yakoub-Agha I, Michel G, Maillard N, Margueritte G, Maury S, Uzunov M, Bulabois CE, Michallet M, Clement L, Dauriac C, Bilger K, Gluckman E, Ruggeri A, Buzyn A, Nguyen S, Simon T, Milpied N, Rocha V; Societe Francaise de Greffe de Moelle et de Therapie Cellulaire and Eurocord. Decreased nonrelapse mortality after unrelated cord blood transplantation for acute myeloid leukemia using reduced-intensity conditioning: a prospective phase II multicenter trial. Biol Blood Marrow Transplant. 2015 Mar;21(3):445-53. doi: 10.1016/j.bbmt.2014.11.009. Epub 2014 Nov 18. PMID 25460357