Test of the combination of prednisone and everolimus as a new approach in treatment of chronic graft-versus-host disease after allogeneic hematopoietic stem cell transplantation with newly diagnosed patients

Phase 1

Conditions: chronic Graft versus Host Disease
MedDRA version: 14.1Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1Level: LLTClassification code 10068907Term: CGVHDSystem Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 10021428 - Immune system disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]
MedDRA version: 14.1Level: LLTClassification code 10063109Term: Transfusion associated GVHDSystem Organ Class: 10021428 - Immune system disorders

Registration Number: EUCTR2011-004847-35-DE

Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

•Diagnosis of classic chronic GvHD according to NIH criteria [33] and fulfilment of criteria for moderate or severe cGvHD
•Diagnosis of overlap syndrome according to NIH criteria [33] and fulfilment of criteria for moderate or severe cGvHD and = clinical grade 2 of acute GvHD of the gut and no grade 4 acute GvHD of the skin.
NB: A maximum of 30 Patients with overlap syndrome will be included in the trial.
•Less than 72 hours after initiation of systemic treatment for cGVHD
•Age = 18 years
•Patient’s written informed consent
•Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, intrauterine devices, oral contraceptives) until three months after termination of treatment

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) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Late persistent or recurrent acute GvHD without evidence of cGvHD
•Relapsed or progressive malignant disease (other than minimal residual disease diagnosed by molecular methods)
•Severe uncontrolled infections
•Pregnant or lactating women
•Inabilty to tolerate 1 mg/kg prednisone
•Inability to take oral medication
•Known hypersensitivity to everolimus
•History of mTOR-inhibitor associated non-infectious pneumonitis
•Participation in another interventional clinical trial with intervention within < 30 days
•Prior use of mTOR-inhibitor (everolimus or sirolimus) for treatment of acute GvHD
•Prior systemic treatment for chronic GvHD> 72h
•Psychiatric illness that would prevent granting of informed consent
•Active viral infection with HIV, hepatitis B or hepatitis C
•Severe cardiovascular disease (uncontrolled arrhythmias, congestive heart failure NYHA III or IV, or symptomatic ischemic heart disease)
•History of mTOR-inhibitor or CNI-associated TMA that led to discontinuation of mTOR-inhibitor or CNI
•Patients with neutrophils < 1000 /µl and / or requiring platelet transfusions at time of screening
•Donor lymphocyte infusion with the last 30 days