Pre-emptive therapy of acute graft versus host disease with prednisolone according to specific proteomic patterns after allogeneic hematopoietic stem cell transplantation. MedDRA version: 16.1 Level: LLT Classification code 10018652 Term: Graft versus host reaction System Organ Class: 100000004870
Conditions
Interventions
Product Name: Prednisolone
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: PREDNISOLONE
CAS Number: 2920867
Other descriptive name: PREDNISOLONE HYDROGEN SUCCIN
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • All patients = 18 years on day +7 (+/- 3) after 1st allo-HSCT • Patients transplanted for: acute myeloid or lymphoid leukemia in CR (=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • Patients after = 2nd allo-HSCT • Patients transplanted in relapse of their underlying disease (AML, ALL: =20% leukemic blast cells in the bone marrow) • Transplantation with CD34+-enriched or ex vivo T-cell-depleted stem cells, transplantation from syngeneic or haploidentical or cord blood donors • Steroids as part of the acute GvHD prophylaxis • Pregnant or nursing women • Participation in an other therapeutic study within 30 days before and during this study Prior to randomization: • Patients with acute GvHD grade II to IV • Acute renal failure (= 2x upper normal boundary of serum creatinine) • Serious, life-threatening infection at the time of sampling for aGvHD proteomic pattern • Relapse or progression of underlying disease (Patients enrolled, who cannot be randomized, will be followed-up in the observational group).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of pre-emptive immunosuppressive treatment (2-2.5mg prednisolone/kg BW/day) versus placebo immediately when a positive acute Graft-versus-Host disease (aGvHD,grade II-IV) and a specific proteomic pattern is observed. ;Secondary Objective: To test the efficacy of pre-emptive treatment of (1) severity of aGvHD, (2) allogeneic HSCT related mortality due to toxicitiy or infections, (3) overall survival, (4) incidence of leukemic relapses and (5) safety of pre-emptive treatment;Primary end point(s): Primary study endpoint: Occurrence of aGvHD (= grade II) between time of randomization and 100 days after allo-HSCT. Death occurring between randomization and 100 days post allo-HSCT without aGvHD (= grade II) will be considered as treatment failure, equivalent to an aGvHD (= grade II) development. ;Timepoint(s) of evaluation of this end point: 100 days after allo-HSCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: (1) until 100 days after allo-HSCT (2)-(6) until end of follow-up period (100 days + 365 days);Secondary end point(s): Secondary study endpoints: (1) Severity of aGvHD until day 100 after allo-HSCT, (2) all aGvHD (= grade II), (3) severity of all aGvHD, (4) transplant-related mortality (TRM), (5) overall survival, (6) occurrence of leukemic relapses and (7) infectious complications. Additional scientific endpoints: To establish proteomic patterns specific for steroid-resistant aGvHD. | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Eva Mischak-Weissinger
Medizinische Hochschule Hannover
Outcome results
None listed