A randomized controlled trial comparing outcome after hematopoietic cell transplantation from a partially matched unrelated versus haploidentical donor - HAMLET

DKMS gemeinnützige GmbH0 sites266 target enrollmentDecember 1, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with high-risk AML, ALL or MDS which have to undergo allogenic transplantaion.
Sponsor: DKMS gemeinnützige GmbH
Enrollment: 266
Status: Active, Not Recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

December 1, 2016

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

DKMS gemeinnützige GmbH

•1\) Signed written informed consent.
•2\) Males and females aged \=18 years old.
•3\) 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\).

•1\)Relapse or graft failure after a first allogeneic transplantation.
•2\)Thymic ALL in first complete remission.
•3\)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)
•4\)Uncontrolled infection at the time of enrollment.
•5\)Pregnant or breast\-feeding women.
•6\)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