Patients with relapse of AML after the 1st allogeneic PBSCT. MedDRA version: 20.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Tepadina
Product Name: Thiotepa
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Fludarabinmedac
Product Name: Fludarabine
Pharmaceutical Form: Concentrate for solution f
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent obtained according to international guidelines and local laws; 2.Male or female patients aged 18-65 years; 3.Patients with AML including secondary and therapy-related AML; 4.Patients with hematological relapse > 6 months after prior allogeneic HCT; 5.Patients designated to undergo second PBSCT from unrelated donor different from the previous donor; 6.Patients with a HLA-A, -B, -C and HLA-DRB1 matched (at least 6 out of 8 alleles; high DNA-based resolution) unrelated donor; 7.Eastern Cooperative Oncology Group (ECOG) performance status of = 2; 8.Ability to understand the nature of the trial and the trial related procedures and to comply with them. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with known congestive heart failure New York Heart Association (NYHA) Class III and IV, cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter, bundle brunch block) or other signs and symptoms of relevant cardiovascular disease; 2.Known Human immunodeficiency virus (HIV) infection, infectious hepatitis (type A, B or C) or another uncontrolled infection; 3.Known hypersensitivity to the active substances or any of the excipients; 4.Renally impaired patients with creatinine clearance < 30 ml/min (Cockcroft-Gault Equation); 5.Decompensated haemolytic anaemia; 6.Any condition, including laboratory abnormalities, which places the subject at unacceptable risk in the study; 7.Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed; 8.Participation in a clinical trial within the last 30 days before the start of this trial (except for registry and diagnostic trials); 9.Known or persistent abuse of medication, drugs or alcohol; 10.Female patients who are pregnant or breast feeding; 11.Fertile patients refusing to use safe contraceptive methods during the study (for details see clinical trial protocol section 4.3).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the probability of disease-free survival, defined as being alive and free of relapse at 1 year after 2nd allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT, 2nd Tx) from unrelated donors after a uniform "intensive-RIC" conditioning with the TFT regimen and defined Graft-versus-Host-Disease (GvHD) prophylaxis;Secondary Objective: • To assess the probability of disease-free survival (DFS) over time • To assess the probability of relapse and non-relapse mortality over time • To assess the probability of overall survival (OS) over time • To assess the probability and severity of acute and chronic GvHD over time • To assess the safety of the regimen ;Primary end point(s): Disease-free survival (DFS) defined as being alive and free of relapse at 1 year post 2nd Tx. ;Timepoint(s) of evaluation of this end point: One year after the second Tx. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • DFS time post 2nd Tx • Time to relapse post 2nd Tx. • Time to non-relapse mortality (NRM) post 2nd Tx • OS time post 2nd Tx. • Time to and severity of acute and chronic GvHD post 2nd Tx. ;Timepoint(s) of evaluation of this end point: - Evaluation day +30, +100 (after 2ndTx) - Evaluation at Month 6, 9, 12, 18, 24, 30, 36 (after 2ndTx) - Extensive follow-up evaluations will be performed after patient’s Visit month 36 up to 36 months after the registration date of the last patient enrolled in the study | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
Clinical Trials Unit University Medical Center Freiburg
Outcome results
None listed