Status:
COMPLETED
Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-versus-host Disease With Prednisone and Everolimus
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Novartis
Crolll Gmbh
Conditions:
Chronic Graft-versus-host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this study patients with moderate to severe chronic graft-versus-host disease will be treated with a combination of prednisone and everolimus. Patients will be treated on the study for a maximum of...
Detailed Description
Background 2.1 Chronic graft-versus-host disease Chronic graft-versus-host disease (cGvHD) is the most common long-term complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT)...
Eligibility Criteria
Inclusion
- 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
- Age ≥ 18 years
- Diagnosis of classic chronic GvHDcGvHD according to NIH criteria \[33\] and fulfilment of criteria for moderate or severe cGvHD or o 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.
Exclusion
- 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
- Inability 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\>of cGvHD ≥ 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 1,000/µl and / /or platelets \< 20.,000/ul µl at time of screening
- Donor lymphocyte infusion within the last 30 days
- Pre-existing hyperlipidemia prior to treatment with calcineurin inhibitor or mTOR inhibitor
- Wound healing complications
- Active lymphoma as well as other malignancies
- Edema (angioneurotic or peripheral)
- Peptic ulcer
- Severe colitis ulcerosa
- Diverticulitis
- Severe osteoporosis
- Poorly- controlled hypertension
- Glaucoma (angle closure or open angle)
- Cornea ulcer or cornea-injuries
- Severe diabetes mellitus
Key Trial Info
Start Date :
March 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01862965
Start Date
March 6 2013
End Date
March 1 2019
Last Update
April 2 2020
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
2
Universitätsklinikum Jena
Jena, Germany, 07743
3
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55101
4
Klinikum der Universität Regensburg
Regensburg, Germany, 93053