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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04232241

Studienbeginn:
November 2019

Letztes Update:
18.01.2020

Wirkstoff:
Allogeneic Stem Cell Transplantation

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Acute, Preleukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphoid, Myelodysplastic Syndromes

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Universitätsklinikum Hamburg-Eppendorf, Universitätsklinikum Hamburg-Eppendorf

Collaborator:
DKMS Stiftung Leben Spenden, Clinical Trial Center North (CTC North GmbH & Co. KG), , DKMS Stiftung Leben Spenden, Clinical Trial Center North (CTC North GmbH & Co. KG)

Studienleiter

Nicolaus Kröger, Prof. Dr.
Principal Investigator
University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation

Kontakt

Studienlocations (3 von 9)

University Hospital Düsseldorf
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Guido Kobbe, Prof. Dr.
E-Mail: kobbe@med.uni-duesseldorf.de
» Ansprechpartner anzeigen
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Dietrich W. Beelen, Prof. Dr.
E-Mail: dietrich.beelen@uk-essen.de
» Ansprechpartner anzeigen
Universitätsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Jürgen Finke, Prof. Dr.
E-Mail: juergen.finke@uniklinik-freiburg.de
» Ansprechpartner anzeigen
Brustzentrum am Universitätsklinikum Hamburg-Eppendorf
Martinistraße 52
20251 Hamburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Nicolaus Kroeger, Prof. Dr.
Phone: +49 (0) 40 7410 55864
E-Mail: n.kroeger@uke.de
» Ansprechpartner anzeigen
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Matthias Eder, Prof. Dr.
E-Mail: eder.matthias@mh-hannover.de
» Ansprechpartner anzeigen
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Matthias Stelljes, Prof. Dr.
E-Mail: Matthias.Stelljes@ukmuenster.de
» Ansprechpartner anzeigen
Pavlov First Saint Petersburg State Medical University
197022 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Boris Afanasyev, Prof. Dr.
E-Mail: bmt-director@1spbgmu.ru
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Relapse incidence at two years between both arms (Time Frame - 2 years):
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:

1. Overall survival at two years between both arms (Time Frame - 2 years):
The overall survival at two years between both arms will be presented with Kaplan-Meier's estimates of survival.

2. Overall survival for all patients assigned to one of the two treatment arms as time to event endpoint (Time Frame - through study completion, an average of two yeras):
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.

3. Comparison of GVHD/relapse-free survival as Composite endpoint in both arms (Time Frame - Starting at day +30 (+/- 3 d) to 24 months (+/- 1 mo) after allogenic stem cell transplantation (SCT)):
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.

4. Comparison of non-relapsed mortality (NRM) at 1 and 2 years after allogeneic SCT in both arms (Time Frame - At 1 and 2 years after allogeneic SCT):
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

5. 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 (Time Frame - On day +100 and 1 year (max grade) after allogeneic SCT):
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.

6. 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 (Time Frame - At 1 and 2 years after allogeneic SCT):
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.

7. Comparison of toxicity of both regimens scored according to the current version of the NCI CTCAE between both arms (Time Frame - through study completion, an average of two yeras):
Safety will be analyzed with frequency of patients with AEs as described above.

8. Comparison of immune reconstitution between both arms (Time Frame - At day 30, 100, 6 months, 1 year and 2 years after allogenic SCT):
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.

9. Comparison of full donor chimerism between both arms (Time Frame - At day 30, 100, 6 months, 1 year and 2 years after allogenic SCT):
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.

10. Evaluation of Sorror Risk Score on outcome after allogeneic SCT (Time Frame - At baseline):
Comorbidity score after Sorror will be assessed prior to randomization and outcome in both arms will be analyzed according the pre-transplant Sorror score.

11. Comparison of QOL (FACT-BMT) before and after transplantation at + 100 days, 6 months, 1 year, 2 years between both arms (Time Frame - At day 100, 6 months, 1 year and 2 years after allogenic SCT):
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.

Studien-Arme

  • Active Comparator: Treatment A
    Allogeneic stem cell transplantation from 10/10 HLA matched unrelated donor
  • Experimental: Treatment B
    Allogeneic stem cell transplantation from haploidentical donor

Geprüfte Regime

  • Allogeneic Stem Cell Transplantation:
    Allogeneic Stem Cell Transplantation

Quelle: ClinicalTrials.gov


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