EUCTR2011-004847-35-DE
Active, not recruiting
Phase 1
Treatment of newly diagnosed moderate or severe chronic graft-versus-host disease with prednisone and everolimus (PredEver first)- A prospective multicenterphase IIA study - - PredEver first
niversity Medical Center Hamburg-Eppendorf0 sites60 target enrollmentMay 3, 2012
Conditionschronic Graft versus Host DiseaseMedDRA version: 14.1Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.1Level: LLTClassification code 10063109Term: Transfusion associated GVHDSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.1Level: LLTClassification code 10068907Term: CGVHDSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsCertican
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- chronic Graft versus Host Disease
- Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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