Proof-of-concept Trial of Apraglutide in GVHD
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (aGVHD).
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Apraglutide
Eligibility
Inclusion Criteria:
- Able to give informed consent and agree to follow the details of participation as
outlined in the protocol
- Male or female subjects aged 12 years or above at the time of consent and who weigh a
minimum of 40 kg. Only subjects aged 18 years and above will be included in Germany.
- Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4) prior to
randomization
- Have undergone alloSCT from any donor source, any conditioning regimen
- Treated with SS plus RUX (RUX starts concomitantly to apraglutide or a maximum of 72
hours before apraglutide initiation)
- Women of childbearing potential (WOCBP): highly effective method of contraception and
refrain from donating eggs during the trial and for 4 weeks after the End of Trial
(EOT) visit
- Male subjects with partner WOCBP: contraception and abstention from sperm donation
during the trial and for 2 weeks after the EOT visit
Exclusion Criteria:
- Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate
and mycophenolate mofetil at the time of randomization / Day 0
- Concomitant treatment with Janus kinase inhibitor other than RUX at the time of
randomization
- Failed alloSCT due to relapse of underlying malignant disease
- Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive
treatment of malignancy recurrence
- Any use of enteral glutamine or GLP analogs or known ADA, within 6 months prior to
randomization / Day 0
- Significant organ system failures (respiratory renal hepatic and cardiac)
- Presence of relapsed primary malignancy or treatment for relapse after alloHSCT
- Presence or history of GI tumors (including the hepatobiliary system and pancreas)
within the last five years before randomization
- Presence of colonic polyps not removed
- Active clinically uncontrolled infection or active tuberculosis
- Known chronic GVHD
- Known active GI inflammation not related to GI-aGVHD
- Major abdominal surgery in the last 6-months prior to randomization or history of
clinically significant intestinal adhesions
- Abnormal liver function tests
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mandy Zeng
mzeng@stanford.edu
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.