Matched Unrelated vs. Haploidentical donor for allogeneic stem cell transplantation in patients with Acute Leukemia with identical GVHD prophylaxis - A randomized porspective European trial.

Phase 2

• Conditions: Acute leukemia; high risk MDS; 10024324

• Registration Number: NL-OMON52639
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- AML intermediate or high risk according to ELN or 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.
- Patients age 18 - 70 years.
- Signed informed consent form
- ECOG <= 2
- 10/10 HLA-matched unrelated donor and haploidentical (>= 5/10 and <= 8/10 HLA)
relative
matched donor

Exclusion Criteria

- Severe renal, hepatic, pulmonary or cardiac disease,
- Positive serology for HIV
- Pregnant or lactating women
- Uncontrolled invasive fungal infection at time of screening (baseline)
- Serious psychiatric or psychological disorders
- Uncontrolled severe autoimmune disease or uncontrolled other malignancy
- Availability of an HLA-identical sibling as donor source

Study & Design

• Study Type: Interventional
• Study Design: Not specified