search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Allogeneic Stem Cell Transplantation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia in Remission focused on measuring Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Allogeneic Stem Cell Transplantation, Matched Unrelated Allogeneic Stem Cell Transplantation, Haploidentical Allogeneic Stem Cell Transplantation, anti-leukemic activity, Cyclophosphamide as GVHD prophylaxis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LKH-Univ. Klinikum GrazRecruiting
  • Medizinische Universität InnsbruckRecruiting
  • Medizinische Universität Wien, Universitätsklinik für Innere Medizin I Einrichtung für Stammzelltransplantation KMTRecruiting
  • Institute of Hematology and Blood TransfusionRecruiting
  • Turku University Central HospitalRecruiting
  • University Hospital DüsseldorfRecruiting
  • Universitätsklinikum EssenRecruiting
  • Universitätsklinikum Frankfurt am Main | Medizinische Klinik II
  • Universitätsklinikum FreiburgRecruiting
  • Universitätsklinikum Hamburg-EppendorfRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Universitätsklinikum Leipzig Dep. Innere Medizin, Neurologie und Dermatologie Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, HämostaseologieRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Universitätsklinikum TübingenRecruiting
  • ASST Papa Giovanni XXIIIRecruiting
  • Pavlov First Saint Petersburg State Medical UniversityRecruiting
  • Hospital Universitari Germans Trias I PujolRecruiting
  • Hospital Clínico y Provincial de BarcelonaRecruiting
  • Hospital de la Santa Creu I Sant PauRecruiting
  • Hospital General Universitario Gregorio MarañónRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting
  • Hospital Universitario y Politécnico de La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment A

Treatment B

Arm Description

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

Allogeneic stem cell transplantation from haploidentical donor

Outcomes

Primary Outcome Measures

Relapse incidence at two years between 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.

Secondary Outcome Measures

Overall survival at two years between both arms
The overall survival at two years between both arms will be presented with Kaplan-Meier's estimates of survival.
Overall survival for all patients assigned to one of the two treatment arms as time to event endpoint
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.
Comparison of GVHD/relapse-free survival as Composite endpoint in both arms
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.
Comparison of non-relapsed mortality (NRM) at 1 and 2 years after allogeneic SCT in 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
Comparison of acute graft-versus-host disease (aGVHD) on day +100 and 1 year (max grade) after allogeneic SCT according to the Glucksberg scale revised by Przepiorka et al. between both arms
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.
Comparison of chronic graft-versus-host disease (cGVHD) according to the NIH consensus criteria of Jagasia et al. at 1 and 2 years after allogeneic SCT between both arms
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.
Comparison of toxicity of both regimens scored according to the current version of the NCI CTCAE between both arms
Safety will be analyzed with frequency of patients with AEs as described above.
Comparison of immune reconstitution between both arms
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.
Comparison of full donor chimerism between both arms
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.
Evaluation of Sorror Risk Score on outcome after allogeneic SCT
Comorbidity score after Sorror will be assessed prior to randomization and outcome in both arms will be analyzed according the pre-transplant Sorror score.
Comparison of QOL (FACT-BMT) before and after transplantation at + 100 days, 6 months, 1 year, 2 years between both arms
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.

Full Information

First Posted
January 2, 2020
Last Updated
October 3, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
DKMS Stiftung Leben Spenden, Clinical Trial Center North (CTC North GmbH & Co. KG)
search

1. Study Identification

Unique Protocol Identification Number
NCT04232241
Brief Title
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
Official Title
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia With Identical GVHD Prophylaxis - A Randomized Prospective European Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
DKMS Stiftung Leben Spenden, Clinical Trial Center North (CTC North GmbH & Co. KG)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes
Keywords
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Allogeneic Stem Cell Transplantation, Matched Unrelated Allogeneic Stem Cell Transplantation, Haploidentical Allogeneic Stem Cell Transplantation, anti-leukemic activity, Cyclophosphamide as GVHD prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
Allogeneic stem cell transplantation from 10/10 HLA matched unrelated donor
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Allogeneic stem cell transplantation from haploidentical donor
Intervention Type
Drug
Intervention Name(s)
Allogeneic Stem Cell Transplantation
Intervention Description
Allogeneic Stem Cell Transplantation
Primary Outcome Measure Information:
Title
Relapse incidence at two years between both arms
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival at two years between both arms
Description
The overall survival at two years between both arms will be presented with Kaplan-Meier's estimates of survival.
Time Frame
2 years
Title
Overall survival for all patients assigned to one of the two treatment arms as time to event endpoint
Description
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.
Time Frame
through study completion, an average of two yeras
Title
Comparison of GVHD/relapse-free survival as Composite endpoint in both arms
Description
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.
Time Frame
Starting at day +30 (+/- 3 d) to 24 months (+/- 1 mo) after allogenic stem cell transplantation (SCT)
Title
Comparison of non-relapsed mortality (NRM) at 1 and 2 years after allogeneic SCT in both arms
Description
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
Time Frame
At 1 and 2 years after allogeneic SCT
Title
Comparison of acute graft-versus-host disease (aGVHD) on day +100 and 1 year (max grade) after allogeneic SCT according to the Glucksberg scale revised by Przepiorka et al. between both arms
Description
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.
Time Frame
On day +100 and 1 year (max grade) after allogeneic SCT
Title
Comparison of chronic graft-versus-host disease (cGVHD) according to the NIH consensus criteria of Jagasia et al. at 1 and 2 years after allogeneic SCT between both arms
Description
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.
Time Frame
At 1 and 2 years after allogeneic SCT
Title
Comparison of toxicity of both regimens scored according to the current version of the NCI CTCAE between both arms
Description
Safety will be analyzed with frequency of patients with AEs as described above.
Time Frame
through study completion, an average of two yeras
Title
Comparison of immune reconstitution between both arms
Description
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.
Time Frame
At day 30, 100, 6 months, 1 year and 2 years after allogenic SCT
Title
Comparison of full donor chimerism between both arms
Description
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.
Time Frame
At day 30, 100, 6 months, 1 year and 2 years after allogenic SCT
Title
Evaluation of Sorror Risk Score on outcome after allogeneic SCT
Description
Comorbidity score after Sorror will be assessed prior to randomization and outcome in both arms will be analyzed according the pre-transplant Sorror score.
Time Frame
At baseline
Title
Comparison of QOL (FACT-BMT) before and after transplantation at + 100 days, 6 months, 1 year, 2 years between both arms
Description
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.
Time Frame
At day 100, 6 months, 1 year and 2 years after allogenic SCT
Other Pre-specified Outcome Measures:
Title
Scientific Endpoint (optional)
Description
Comparison of relapse incidence at two years between MRD positive and negative patients in both arms
Time Frame
2 years
Title
Scientific Endpoint (optional)
Description
Comparison of overall survival at two years between MRD positive and negative patients in both arms
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Patients age: 18 - 70 years at time of inclusion (female and male). Patients understand and voluntarily sign an informed consent form. ECOG ≤ 2. 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. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol. Exclusion Criteria 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 Positive serology for HIV. Pregnant or lactating women (positive serum pregnancy test). Age < 18 and ≥ 71 years. Uncontrolled invasive fungal infection at time of screening (baseline). Serious psychiatric or psychological disorders. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment. Uncontrolled severe autoimmune disease or uncontrolled other malignancy. Availability of an HLA-identical sibling as donor source.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolaus Kröger, Prof. Dr.
Phone
+49 (0) 40 7410 55864
Email
n.kroeger@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Frauke Bach, Dr.
Phone
+49 (0) 40 7410 23182
Email
f.bach@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kröger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKH-Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hildegard Greinix, Prof. Dr.
Email
Hildegard.Greinix@klinikum-graz.at
First Name & Middle Initial & Last Name & Degree
Hildegard Greinix, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Heinz Sill, Prof. Dr.
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Nachbaur, Prof. Dr.
Facility Name
Medizinische Universität Wien, Universitätsklinik für Innere Medizin I Einrichtung für Stammzelltransplantation KMT
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Wohlfarth, PD Dr.
Email
Philipp.wohlfarth@meduniwien.ac.at
Facility Name
Institute of Hematology and Blood Transfusion
City
Prague
ZIP/Postal Code
128 20 Praha 2
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markéta Marková, MUDr.
First Name & Middle Initial & Last Name & Degree
Jana Brzonova
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maija Itälä-Remes, Prof. Dr.
Email
maija.itala-remes@tyks.fi
First Name & Middle Initial & Last Name & Degree
Maija Itälä-Remes, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Urpu Salmenniemi, Prof. Dr.
Facility Name
University Hospital Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Kobbe, Prof. Dr.
Email
kobbe@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Guido Kobbe, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Thomas Schröder, Dr.
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietrich W. Beelen, Prof. Dr.
Email
dietrich.beelen@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Dietrich W. Beelen, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Rudolf Trenschel, Dr.
Facility Name
Universitätsklinikum Frankfurt am Main | Medizinische Klinik II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gesine Bug, PD Dr.
Email
g.bug@em.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Vera Schlipfenbacher, Dr.
Email
vera.schlipfenbacher@kgu.de
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Finke, Prof. Dr.
Email
juergen.finke@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Jürgen Finke, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Hartmut Bertz, Prof. Dr.
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Phone
+49 (0) 40 7410 55864
Email
n.kroeger@uke.de
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Christine Wolschke, Dr.
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Eder, Prof. Dr.
Email
eder.matthias@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Matthias Eder, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Gernot Beutel, Dr.
Facility Name
Universitätsklinikum Leipzig Dep. Innere Medizin, Neurologie und Dermatologie Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, Hämostaseologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg-Nikolaus Franke, Dr.
Email
georg-nikolaus.franke@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Vladan Vucinic, Dr.
Email
Vladan.vucinic@medizin.uni-leipzig.de
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Stelljes, Prof. Dr.
Email
Matthias.Stelljes@ukmuenster.de
First Name & Middle Initial & Last Name & Degree
Matthias Stelljes, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Jan-Henrik Mikesch, Dr.
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Bethge, Prof. Dr.
Email
wolfgang.bethge@med.unituebingen.de
First Name & Middle Initial & Last Name & Degree
Wolfgang Bethge, Prof. Dr.
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Rambaldi, Prof. Dr.
Email
arambaldi@asst-pg23.it
Facility Name
Pavlov First Saint Petersburg State Medical University
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Bondarenko, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ivan Moiseev, MD, PhD
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle Ferrà Coll, MD-PhD
Email
cferra@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Christelle Ferrà Coll, MD-PhD
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Martínez Muñoz, Dr.
Email
cmarti@clinic.cat
First Name & Middle Initial & Last Name & Degree
Carmen Martínez Muñoz, Dr.
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo M Martino Bufarull, Dr.
Email
rmartino@santpau.cat
First Name & Middle Initial & Last Name & Degree
Rodrigo Martino Bufarull, Dr.
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Kwon, MD, PhD
Email
mi.kwon@salud.madrid.org
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Caballero Barrigón, Dr.
Email
cabarri@usal.es
First Name & Middle Initial & Last Name & Degree
Dolores Caballero Barrigón, Dr.
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José A Pérez Simón, Dr.
Email
josea.perez.simon.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
José A Pérez Simón
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Solano, MD, PhD
Email
carlos.solano@uv.es
First Name & Middle Initial & Last Name & Degree
Carlos Solano, MD, PhD
Facility Name
Hospital Universitario y Politécnico de La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Sanz Caballer, Dr.
Email
sanz_jai@gva.es
First Name & Middle Initial & Last Name & Degree
Jaime Sanz Caballer, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34049582
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs