Last reviewed · How we verify
NCT04232241
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
Phase 2 trial testing Allogeneic Stem Cell Transplantation in Acute Myeloid Leukemia in Remission in 167 participants. Participants enrolled and being followed up; not accepting new ones.
22 November 2026
Quick facts
| Lead sponsor | Universitätsklinikum Hamburg-Eppendorf |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 167 |
| Start date | 14 November 2019 |
| Primary completion | 22 November 2026 |
| Estimated completion | 26 November 2026 |
| Sites | 24 locations across Italy, Finland, Russia, Austria, Germany, Spain, Czechia |
Drugs / interventions tested
- Allogeneic Stem Cell Transplantation — full drug profile →
Conditions studied
- Acute Myeloid Leukemia in Remission — all drugs for Acute Myeloid Leukemia in Remission →
- Acute Lymphoblastic Leukemia in Remission — all drugs for Acute Lymphoblastic Leukemia in Remission →
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
Sponsor
Universitätsklinikum Hamburg-Eppendorf — full company profile →
Who can join
Adults 18 to 70, any sex, with Acute Myeloid Leukemia in Remission or Acute Lymphoblastic Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anti-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA matched unrelated donor and a haploidentical donor. The hypothesis: Haploidentical stem cell transplantation with post cyclophosphamide induces a stronger anti-leukemic activity in comparison to 10/10 HLA matched unrelated donor and reduces the risk of relapse at 2 years after stem cell transplantation by 10%.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Post-transplant cyclophosphamide containing regimens after matched sibling, matched unrelated and haploidentical donor transplants in patients with acute lymphoblastic leukemia in first complete remission, a comparative study of the ALWP of the EBMT.
Sanz J, Galimard JE, Labopin M, Afanasyev B, et al · · 2021 · cited 39× · PMID 34049582 · DOI 10.1186/s13045-021-01094-2 -
Haploidentical Stem Cell Transplantation for Acute Myeloid Leukemia: Current Therapies, Challenges and Future Prospective.
Chang YJ, Zhao XY, Huang XJ. · · 2021 · cited 15× · PMID 34778077 · DOI 10.3389/fonc.2021.758512 -
Effective Immunosurveillance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia.
Kunadt D, Stölzel F. · · 2021 · cited 3× · PMID 34594134 · DOI 10.2147/cmar.s261721 -
The EHA Research Roadmap: Hematopoietic Stem Cells and Allotransplantation.
Fibbe W, Bernardi R, Charbord P, Krause D, et al · · 2022 · cited 1× · PMID 35509429 · DOI 10.1097/hs9.0000000000000714
Verify or expand the search:
- PubMed search for NCT04232241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allogeneic Stem Cell Transplantation
Trials testing the same drug.
- NCT07297173 — Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia · Phase 1 · recruiting
- NCT06345495 — High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly · Phase 2 · recruiting
- NCT02410551 — Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN) · Phase 2 · terminated
- NCT02059239 — Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma · Phase 1, PHASE2 · completed
- NCT02098512 — Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin L · Phase 1, PHASE2 · unknown
Other recruiting trials for Acute Myeloid Leukemia in Remission
Currently open trials in the same condition.
- NCT06440135 — Ziftomenib Maintenance Post Allo-HCT · Phase 1 · recruiting
- NCT06462365 — Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT) · Phase 1 · recruiting
- NCT05236764 — Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion · NA · active not recruiting
- NCT05917405 — Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT · Phase 2 · recruiting
- NCT05224661 — Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events · active not recruiting
Other Universitätsklinikum Hamburg-Eppendorf trials
Trials by the same sponsor.
- NCT07443384 — Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus · not yet recruiting
- NCT07385092 — Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery · NA · recruiting
- NCT07009522 — Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART) · EARLY_PHASE1 · not yet recruiting
- NCT07115394 — EEG Measurements to Capture DBS-induced Electric Potentials · recruiting
- NCT06955884 — Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04232241 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf
- Last refreshed: 22 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04232241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing