Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MT2020-28 | Other Identifier | Masonic Cancer Center |
Not provided
Not provided
Not provided
Sponsor terminated financial support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD.
This is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at day 28 when given in conjunction with uhCG/EGF and ruxolitinib.
After completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk aGVHD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib;hCG (Pregnyl®) ;Corticosteroids | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib 10 MG Oral Tablet | Drug | By mouth twice daily through day 56, then tapered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommend the lowest possible dose for Phase II of corticosteroids when given in combination with ruxolitinib and uhCG/EGF in pediatric based on DLT frequency | Plan report patients proportions and their 95% confidence intervals of paitents who experience dose limiting toxicity. Determine best dose based on DLT criteria by CTCAE v5.0
| 28 days after therapy |
| Best response of treatment in adult and children | proportions of complete, partial, mixed, and no response among surviving patients at days 28 after initiation of protocol therapy in pediatric and adult patients with Minnesota high-risk aGVHD | 28 days after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Report any type of adverse event caused by a drug cause by dose of steroids in combination of ruxolitinib and uhCG/EGF. Due to the complex medical condition of the GVHD patient, monitoring for adverse events will focus on the following events beginning with the date consent is signed and continuing for 30 days after the subject has completed or discontinued from the study or has taken last dose of the study drug.
|
Not provided
Inclusion Criteria:
HCT recipients over 12 years of age within the first 7 days of initial treatment of high-risk aGVHD, defined as:
Newly diagnosed Minnesota high-risk aGVHD -OR-
Newly diagnosed Minnesota standard risk aGVHD with plasma amphiregulin ≥ 33 pg/ml tested at the UMN Cytokine Reference Lab. For amphiregulin lab ordering information, see Fairview Lab Guide: http://labguide.fairview.org/showtest.asp?testid=6766\&format=long -OR-
Newly diagnosed Minnesota standard risk aGVHD Ann Arbor 3 biomarkers tested by Viracor. For ordering information, see: https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic- onset-algorithm/
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherman Holtan, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D006063 | Chorionic Gonadotropin |
| D000305 | Adrenal Cortex Hormones |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| hCG | Drug | 2,000 units/m2 SQ every other day x 3 doses, followed by twice weekly x 14 doses |
|
|
| Corticosteroids | Drug | Dose level 1 (starting dose) = 1 mg/kg
|
|
|
| 30 days after treatment |
| Incidence of acute GVHD flare after CR/PR requiring increase of steroids or other systemic treatment | Find proportion of incidence of acute GVHD | 28 days after treatment |
| Incidence of acute GVHD flare after CR/PR requiring increase of steroids or other systemic treatment | Find proportion of incidence of acute GVHD | 56 days after treatment |
| Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls | Compare count of treatment failure to other number of failures in other historical protocols | 28 days after treatment |
| Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls | Compare count of treatment failure to other number of failures in other historical protocols | 56 days after treatment |
| To assess patient quality of life on study | Have participants take an overall survival survey | 6 month after treatment |
| Determine 1-year overall survival | Provide proportions and their 95% confidence intervals of patients still alive at one year post-treatment | 1 year post treatment |
| Non-relapse mortality (death without recurrent or progressive disease after allo-HSCT) | Provide proportions and their 95% confidence intervals of patients who expedience a non-relapse mortality. | 1 year post treatment |
| Collect blood samples and rectosigmoid biopsies for future correlative studies | Give a count of the number of patients who had blood and rectosigmoid biopsies | 1 year after treament |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |