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Clinical Trials in Germany / NCT04232241
Active, not recruiting Phase 2

Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

NCT04232241 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2019-11-14
Last updated
2025-04-22

Condition(s) studied

Acute Myeloid Leukemia in RemissionAcute Lymphoblastic Leukemia in RemissionMyelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Allogeneic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation: Allogeneic Stem Cell Transplantation

Study summary

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%.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria 1. Acute Myeloid Leukemia (AML) intermediate or high risk according to ELN or Acute Lymphoblastic Leukemia (ALL) high risk according to ESMO guidelines in 1. CR or AML/ALL in 2. CR, or high risk MDS (according to IPSS-R) in 1. CR or 2. CR. 2. Patients age: 18 - 70 years at time of inclusion (female and male). 3. Patients understand and voluntarily sign an informed consent form. 4. ECOG ≤ 2. 5. 10/10 HLA-matched unrelated donor and haploidentical (≥ 5/10 and ≤ 8/10 HLA) relative matched donor available at least 4 weeks after completion of induction and/or consolidation therapy. 6. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol. Exclusion Criteria 1. Severe renal, hepatic, pulmonary or cardiac disease, such as: * total bilirubin, SGPT or SGOT \> 3 times upper the normal level * left ventricular ejection fraction \< 30 % * creatinine clearance \< 30 ml/min * DLCO \< 35 % and/or receiving supplementary continuous oxygen 2. Positive serology for HIV. 3. Pregnant or lactating women (positive serum pregnancy test). 4. Age \< 18 and ≥ 71 years. 5. Uncontrolled invasive fungal infection at time of screening (baseline). 6. Serious psychiatric or psychological disorders. 7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment. 8. Uncontrolled severe autoimmune disease or uncontrolled other malignancy. 9. Availability of an HLA-identical sibling as donor source.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
LKH-Univ. Klinikum Graz Graz Austria
Medizinische Universität Innsbruck Innsbruck Austria
Medizinische Universität Wien, Universitätsklinik für Innere Medizin I Einrichtung für Stammzelltransplantation KMT Vienna Austria
Institute of Hematology and Blood Transfusion Prague Czechia
Turku University Central Hospital Turku Finland
University Hospital Düsseldorf Düsseldorf Germany
Universitätsklinikum Essen Essen Germany
Universitätsklinikum Frankfurt am Main | Medizinische Klinik II Frankfurt Germany
Universitätsklinikum Freiburg Freiburg im Breisgau Germany
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany
Medizinische Hochschule Hannover Hanover Germany
Universitätsklinikum Leipzig Dep. Innere Medizin, Neurologie und Dermatologie Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, Hämostaseologie Leipzig Germany
Universitätsklinikum Münster Münster Germany
Universitätsklinikum Tübingen Tübingen Germany
ASST Papa Giovanni XXIII Bergamo Italy
Pavlov First Saint Petersburg State Medical University Saint Petersburg Russia
Hospital Universitari Germans Trias I Pujol Badalona Spain
Hospital Clínico y Provincial de Barcelona Barcelona Spain
Hospital de la Santa Creu I Sant Pau Barcelona Spain
Hospital General Universitario Gregorio Marañón Madrid Spain
Hospital Universitario de Salamanca Salamanca Spain
Hospital Universitario Virgen del Rocío Seville Spain
Hospital Clínico Universitario de Valencia Valencia Spain
Hospital Universitario y Politécnico de La Fe Valencia Spain

More Universitätsklinikum Hamburg-Eppendorf trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04232241 on ClinicalTrials.gov ↗ ← All trials in Germany