Haploidentical Donor vs mMUD in Hematological Malignancies

NCT03275636 | Completed Phase 2 DMC

• 2 other identifiers: DKMS-16-012015-005399-12
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 9

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.

Conditions

AML; ALL; MDS

Keywords

Haploidentical; mismatched unrelated donor; hematopoietic stem cell transplantation; donor comparison

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival calculated from the time of randomization will be the primary endpoint of this trial. Death from any reason will be considered as event.

  2 years

Secondary Outcomes (6)

• Engraftment rate

  day 56

• Immune-reconstitution rate

  day56

• Infections

  2 months after HCT

• Event Free Survival

  1 year

• Graft vs Host Disease

  1 year

Study Arms (2)

Haploidentical donor

EXPERIMENTAL

Peripheral blood stem cells from Haploidentical donor

Biological: Peripheral blood stem cells

partially matched unrelated donor

ACTIVE COMPARATOR

Peripheral blood stem cells from 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

Biological: Peripheral blood stem cells

Interventions

Peripheral blood stem cells BIOLOGICAL

Hematopoietic stem cell transplantation with PBSC

Also known as: PBSC

Haploidentical donor; partially matched unrelated donor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DKMS gemeinnützige GmbH: lead

Study Sites (9)

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60595, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Study Officials

• Johannes Schetelig, Prof Dr med

  Universtitätsklinikum Dresden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 7, 2017
• Study Start: January 1, 2018
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

DE (9)