Graft versus Host Disease MedDRA version: 20.0 Level: LLT Classification code 10018799 Term: GVHD System Organ Class: 100000004870
Conditions
Interventions
Product Name: Ciclosporine
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ciclosporine
CAS Number: 59865-13-3
Trade Name: Myfortic 180 mg
Product Name: Myfortic
Pharmaceutical Form: Tablet
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-70 inclusive - AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD) - Planned allogeneic stem cell transplantation - Related or unrelated donor with a 8/8 genotypical HLA match (HLA A, B, C, DRB1) - WHO performance status 0-2 - Written Informed Consent - Negative pregnancy test (if applicable) - Patients who are willing and capable to use adequate contraception during Myfortic treatment (all pre-menopausal women) 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 490 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Renal dysfunction (serum creatinine > 150 mmol/L or clearance 5% marrow blasts in case of AML, ALL, CML - Patients with EMD in case of AML, ALL, CML
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives: - to increase the proportion of patients with non severe GVHD within 180 days post-allo-SCT, - to reduce the progression rate and - to improve the progression free survival using a time restricted immunosuppressive regimen or a short-course post-transplant GVHD prophylaxis consisting of high-dose cyclophosphamide as compared to a prolonged, standard immunosuppressive regimen. • to asses the impact of allogeneic SCT on the quality of life in a prospectively treated cohort of patients ;Secondary Objective: - to develop a predictive score, by means of clinical and laboratory parameters (using genomic and proteomic approaches) that allows for accurate identification of patients at high risk of severe GVHD as well as for identification of patients, who will not develop GVHD;Primary end point(s): - Proportion of patients with non-severe GVHD (acute GVHD grade I, grade II without gut infiltration, or chronic GVHD not requiring systemic treatment) within D180 after randomization / registration. ;Timepoint(s) of evaluation of this end point: As soon as all data regarding the primary endpoint of the randomization are available and have been validated | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Additional analyses will be performed when for all patients the data required for analysis of the secondary endpoints have been evaluated, and also when complete follow up until 5 years after allo-SCT is available for all patients;Secondary end point(s): - time to acute GVHD grade I, II, III, IV - cumulative incidence of progression - progression-free survival (defined as time from randomization 1 until progression or death, whichever occurs first) - cumulative incidence of non-relapse mortality - overall survival (cause of death should be defined according to Appendix F) - time to chronic GVHD limited and extensive - adverse events - Quality of life (of randomized patients) as defined by the EORTC QLQ-C30 and the FACT-BMT definitions | — |
Countries
Belgium, Netherlands
Contacts
Public ContactHOVON Data Center
HOVON
Outcome results
None listed