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

NCT ID: NCT04232241

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-14
• Study Completion Date: 2026-11-26

Brief 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%.

Detailed Description

Secondary objectives are to assess and compare the safety and efficacy of study treatments therapy in both study arms on non-relapse mortality (NRM), relapse-free survival (RFS), Overall survival (OS), QOL, toxicity, development of acute and chronic GvDH as well as engraftment and chimerism and impact of measurable residual disease.

Conditions

Acute Myeloid Leukemia in Remission; Acute Lymphoblastic Leukemia in Remission; Myelodysplastic Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Allogeneic stem cell transplantation from 10/10 HLA matched unrelated donor

Group Type: ACTIVE_COMPARATOR

Allogeneic Stem Cell Transplantation

Intervention Type: DRUG

Allogeneic Stem Cell Transplantation

Treatment B

Allogeneic stem cell transplantation from haploidentical donor

Group Type: EXPERIMENTAL

Allogeneic Stem Cell Transplantation

Intervention Type: DRUG

Allogeneic Stem Cell Transplantation

Interventions

Allogeneic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GKM Gesellschaft für Therapieforschung mbH

UNKNOWN

Sponsor Role: collaborator

Staburo GmbH

INDUSTRY

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolaus Kröger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation

Locations

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

Countries

Austria; Czechia; Finland; Germany; Italy; Russia; Spain

References

Sanz J, Galimard JE, Labopin M, Afanasyev B, Sergeevich MI, Angelucci E, Kroger N, Koc Y, Ciceri F, Diez-Martin JL, Arat M, Sica S, Rovira M, Aljurf M, Tischer J, Savani B, Ruggeri A, Nagler A, Mohty M. 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. J Hematol Oncol. 2021 May 28;14(1):84. doi: 10.1186/s13045-021-01094-2.

Reference Type: DERIVED

PMID: 34049582 (View on PubMed)

Other Identifiers

HaploMUDStudy

Identifier Type: -

Identifier Source: org_study_id