Acute Myeloid Leukemia MedDRA version: 21.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Allogeneic hematopoietic stem cell formulation from peripheral blood.
Pharmaceutical Form: Solution for infusion
Sponsors
University Medical Center Hamburg - Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival at two years between both arms 2. Overall survival for all patients assigned to one of the two treatment arms as time to event endpoint 3. Comparison of GVHD/relapse-free survival as composite endpoint in both arms 4. Comparison of non-relapsed mortality (NRM) at 1 and 2 years after allogeneic SCT in both arms 5. Comparison of acute graft-versus-host disease (aGVHD) on day +100 and 1 year (max grade) after allogeneic SCT according to the Glucksberg scale revised by Przepiorka et al. between both arms 6. Comparison of chronic graft-versus-host disease (cGVHD) according to the NIH consensus criteria of Jagasia et al. at 1 and 2 years after allogeneic SCT between both arms 7. Comparison of toxicity of both regimens scored according to the current version of the NCI CTCAE between both arms 8. Comparison of immune reconstitution and full donor chimerism between both arms 9. Evaluation of Sorror Risk Score [8] (Appendix 13.1) on outcome after allogeneic SCT 10. Comparison of QOL (FACT-BMT) before and after transplantation at + 100 days, 6 months, 1 year, 2 years between both arms;Timepoint(s) of evaluation of this end point: Baseline, Day 30, Day 100, 6 months, 12 months, 24 months | — |
Countries
Germany
Contacts
Public ContactNicolaus Kroeger
University Medical Center Hamburg -- Eppendorf
Outcome results
None listed