Status:
COMPLETED
Haploidentical Donor vs mMUD in Hematological Malignancies
Lead Sponsor:
DKMS gemeinnützige GmbH
Conditions:
AML
ALL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this trial is to compare the outcome after partially matched (single mismatch) unrelated donor transplantation with haploidentical transplantation in a randomized controlled setting.
Detailed Description
For patients with an indication for allogeneic HCT, the search for a stem cell donor is a challenge. 20% of patients who need an allograft have an HLA-identical sibling available, and for approximatel...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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 by chemotherapy-refractory disease.
- AML with favourable genetic abnormalities (according to ELN guidelines) after relapse or by 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 score)2.
- First CR of high-risk ALL, defined by one or more of these:
- Early or mature T-ALL (CD1a negative).
- Pro B-ALL with t(4v;11); KMT2A-rearrangements.
- Presence of BCR-ABL and/or t(9;22).
- 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.
- Exclusion criteria
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03275636
Start Date
January 1 2018
End Date
April 13 2024
Last Update
August 7 2024
Active Locations (9)
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1
Universitätsklinikum Bonn
Bonn, Germany, 53105
2
Universitätsklinikum Dresden
Dresden, Germany
3
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60595
4
Universitätsklinikum Halle (Saale)
Halle, Germany, 06120