Deutsches Leukämie-Studienregister
Studie: HAMLET

Kurzübersicht
Öffentlicher Titel Haploider versus teilweise HLA-identischer nicht-verwandter Spender bei hämatologischen Neoplasien
Wissenschaftl. Titel A randomized controlled trial comparing outcome after hematopoietic cell transplantation from a partially matched unrelated versus haploidentical donor
Kurztitel HAMLET
Studiennummer KN/ELN LN_NN_2019_649
Studiengruppe NN
Studienart multizentrisch, prospektiv, offen, zweiarmig
Studienphase Phase II/III
Erkrankung Stammzelltransplantation (SZT) - ALL
Stammzelltransplantation (SZT) - AML
Stammzelltransplantation (SZT) - MDS
Leukämiestadium .
Einschlusskriterien
  • Males and females aged >= 18 years old.
  • Eligible diagnoses are listed below:
  • -> AML with adverse risk genetic abnormalities (according to the ELN guidelines)1.
  • -> AML with intermediate genetic abnormalities (according to ELN guidelines) either in first complete remission, after relapse, or with chemotherapy-refractory disease
  • -> AML with favourable genetic abnormalities (according to ELN guidelines) after relapse or with chemotherapy-refractory disease, except APL
  • -> AML with undefined genetic risk classification after relapse or with chemotherapy-refractory disease
  • -> AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN guidelines) are present
  • -> Therapy-related myeloid neoplasia except if favorable genetic abnormalities (according to ELN guidelines) are present
  • -> MDS with high risk or very high risk disease (according to the IPSS-R score2)
  • -> First CR of high-risk ALL, defined by one or more of these:
  • a) Early or mature T-ALL (CD1a negative).
  • b) Pro B-ALL with t(4v;11); KMT2A-rearrangements
  • c) Presence of BCR-ABL and/or t(9;22).
  • d) Persistence of minimal residual disease after the second induction course.
  • -> ALL with or without complete remission after salvage therapy following poor response to induction therapy
  • -> ALL after haematological or molecular relapse.
  • Fit for transplant according to physician judgement.
  • No history of cardiac disease and absence of active symptoms, otherwise, documented left ventricular ejection fraction >=40%.
  • No history of chronic pulmonary disease and absence of dyspnea
  • -> Otherwise, documented diffusion lung capacity for carbon monoxide (DLCO) >=40% or FEV1/FVC >= 50% despite appropriate treatment Availability of >=1 unrelated donor with a single allele or antigen mismatch at HLA-A, -B, -C, or -DRB1 and no concurrent DQB1 mismatch (9/10) shown by confirmatory typing
  • Availability of at least one haploidentical donor meeting the following criteria:
  • -> Donor is a biologic parent / child of the patient or haploidentity has been confirmed for patient’s relatives by HLA-Typing.
  • -> The donor has expressed his / her will to donate, and has no contraindications against a stem cell donation by medical history
  • -> Donor age is >=18 years and <=75 years
Ausschlusskriterien
  • Relapse or graft failure after a first allogeneic transplantation.
  • Thymic ALL in first complete remission
  • Severe organ dysfunction defined by either of the following three criteria:
  • -> Patients who receive supplementary continuous oxygen.
  • -> Serum bilirubin >1.5 x ULN (if not considered Gilbert-Syndrome) or ASAT/ALAT >5 x ULN.
  • -> Estimated Glomerular Filtration Rate (GFR) < 40 ml/min, where: Estimated GFR (mL/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)- 0.203 x (0.742 if patient is female) x (1.212 if patient is black)
  • Uncontrolled infection at the time of enrollment.
  • Pregnant or breast-feeding women
  • An HLA-identical sibling donor or 8/8 (HLA-A, -B, -C, or -DRB1) matched unrelated donor is available and suitable to donate prior to randomization
  • Men unable or unwilling to use adequate contraception methods from enrollment to minimum of six months after the last dose of chemotherapy
  • Women of childbearing potential except those who fulfill the following criteria: Post-menopausal or post-operative or continuous and correct application of a contraception method with a Pearl Index <1% or sexual abstinence or vasectomy of the sexual partner
  • Simultaneous participation in another clinical trial.
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 05.04.2019
Kurzprotokoll Kurzprotokoll
Sponsoren DKMS
Förderer DKMS
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT03275636
European Clinical Trials Database - EUDRACT 2015-005399-12
erstellt 29.04.2019 Student Studienregister
geändert 09.05.2019 Zenawit Krüger
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