Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients with Acute Leukemia with Identical GVHD Prophylaxis

Phase 1

Conditions: Acute Myeloid Leukemia
MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-002331-41-DE

Lead Sponsor: niversity Medical Center Hamburg - Eppendorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 440

Inclusion Criteria

1. Acute Myeloid Leukemia (AML) intermediate or high risk according to ELN or Acute Lymphoblastic Leukemia (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.
2. Patients age: 18 - 70 years at time of inclusion (female and male)
3. Patients understand and voluntarily sign an informed consent form
4. ECOG = 2
5. 10/10 HLA-matched unrelated donor [9/10 mismatch is allowed if HLA mismatch is located in DQB1 (by high resolution typing)] and haploidentical (= 5/10 and = 8/10 HLA) relative matched donor available at least 4 weeks after completion of induction and/or consolidation therapy. The mismatch related donor should not be older than 65 years of age.
6. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Severe renal, hepatic, pulmonary or cardiac disease, such as:
- total bilirubin, SGPT or SGOT > 3 times upper the normal level
- left ventricular ejection fraction < 30 %
- creatinine clearance < 30 ml/min
- DLCO < 35 % and/or receiving supplementary continuous oxygen
2. Positive serology for HIV
3. Pregnant or lactating women (positive serum pregnancy test)
4. Age < 18 and = 71 years.
5. Uncontrolled invasive fungal infection at time of screening (baseline)
6. Serious psychiatric or psychological disorders
7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
8. Uncontrolled severe autoimmune disease or uncontrolled other malignancy
9. Availability of an HLA-identical sibling as donor source

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare anti-leukemic activity of allogeneic stem cell trans-plantation for patients with acute leukemia, in complete remis-sion between a 10/10 HLA matched unrelated donor and a haploidentical donor.;Secondary Objective: To assess and compare the safety and efficacy of study treat-ments therapy in both study arms on non-relapse mortality (NRM), relapse-free survival (RFS), Overall survival (OS), QOL, toxicity, development of acute and chronic GvDH as well as engraftment and chimerism and impact of measurable residual disease.;Primary end point(s): 1. Relapse incidence at two years between both arms;Timepoint(s) of evaluation of this end point: Baseline, Day 30, Day 100, 6 months, 12 months, 24 months

Secondary Outcome Measures