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

Allogeneic stem cell transplantation from haploidentical donor

Allogeneic Stem Cell Transplantation

Nicolaus Kröger, Prof. Dr.

Frauke Bach, Dr.

Hildegard Greinix, Prof. Dr.

Heinz Sill, Prof. Dr.

David Nachbaur, Prof. Dr.

Philipp Wohlfarth, PD Dr.

Markéta Marková, MUDr.

Jana Brzonova

Maija Itälä-Remes, Prof. Dr.

Urpu Salmenniemi, Prof. Dr.

Guido Kobbe, Prof. Dr.

Thomas Schröder, Dr.

Dietrich W. Beelen, Prof. Dr.

Rudolf Trenschel, Dr.

Gesine Bug, PD Dr.

Vera Schlipfenbacher, Dr.

Jürgen Finke, Prof. Dr.

Hartmut Bertz, Prof. Dr.

Nicolaus Kroeger, Prof. Dr.

Christine Wolschke, Dr.

Matthias Eder, Prof. Dr.

Gernot Beutel, Dr.

Georg-Nikolaus Franke, Dr.

Vladan Vucinic, Dr.

Matthias Stelljes, Prof. Dr.

Jan-Henrik Mikesch, Dr.

Wolfgang Bethge, Prof. Dr.

Alessandro Rambaldi, Prof. Dr.

Sergey Bondarenko, MD, PhD

Ivan Moiseev, MD, PhD

Christelle Ferrà Coll, MD-PhD

Carmen Martínez Muñoz, Dr.

Rodrigo M Martino Bufarull, Dr.

Rodrigo Martino Bufarull, Dr.

Mi Kwon, MD, PhD

Dolores Caballero Barrigón, Dr.

José A Pérez Simón, Dr.

José A Pérez Simón

Carlos Solano, MD, PhD

Jaime Sanz Caballer, Dr.

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%.

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.

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

Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia With Identical GVHD Prophylaxis - A Randomized Prospective European Trial.

Comparison of relapse incidence at two years between MRD positive and negative patients in both arms

Comparison of overall survival at two years between MRD positive and negative patients in both arms

The primary efficacy endpoint will be analyzed using cumulative incidence estimation to assess the subdistribution hazard rates for both treatment groups at two years after accounting for competing risk events.

The overall survival at two years between both arms will be presented with Kaplan-Meier's estimates of survival.

The overall survival for all patients will be presented with Kaplan-Meier curve. To compare the survival distributions between two arms, log-rank test will be performed, and two-sided p-values will be presented.

If applicable, Cox regression model stratified by the types of leukemia, types of complete remission and conditioning will be performed as sensitivity analysis.

The rate of composite endpoint in both arms will be analyzed with the same methods as for the overall survival at two years between both arms.

Due to the existence of competing risk events (persisting disease and relapse), NRM of each arm at 1 and 2 years after allogeneic SCT will be analyzed with the same methods as for the primary endpoint

For each time point, the frequency and percentage of aGVHD (maximum grade) of each arm will be presented. To compare the difference between both arms, logistic regression adjusted for covariates and stratification factors will be performed.

For each time point, the frequency and percentage of cGVHD of each arm will be presented. To compare the difference between both arms, logistic regression adjusted for the stratification factors will be performed.

Safety will be analyzed with frequency of patients with AEs as described above.

Frequency and percentage of patients having immune reconstitution in two arms will be provided. For the comparison between two arms, logistic regression adjusted for the stratification factors will be performed.

Frequency and percentage of patients having full donor chimerism in two arms will be provided. For the comparison between two arms, logistic regression adjusted for the stratification factors will be performed.

Comorbidity score after Sorror will be assessed prior to randomization and outcome in both arms will be analyzed according the pre-transplant Sorror score.

The means of change in scores at each time point (day 100, 6 months, 1 year and 2 years after transplantation respectively) from baseline and the confidence intervals of each arm will be presented. To compare the difference in QOL scores between both arms, logistic regression adjusted for covariates and stratification factors will be performed for each time point.

DKMS Stiftung Leben Spenden

Clinical Trial Center North (CTC North GmbH & Co. KG)

Universitätsklinikum Hamburg-Eppendorf

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia	NCT04232241	Acute Myeloid L... Acute Lymphobla... Myelodysplastic...	Allogeneic Stem...	18 Years - 70 Years	Universitätsklinikum Hamburg-Eppendorf
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia	NCT04232241	Acute Myeloid L... Acute Lymphobla... Myelodysplastic...	Allogeneic Stem...	18 Years - 70 Years	Universitätsklinikum Hamburg-Eppendorf

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