| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00562497 | Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD) | PHASE3 | COMPLETED | 192 | — | — | Jan 31, 2008 | May 20, 2010 | Jan 19, 2022 | 53 | United States, Australia +1 |
| NCT00366145 | Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD) | PHASE3 | COMPLETED | 260 | — | — | Aug 17, 2006 | May 28, 2009 | Feb 10, 2022 | 70 | United States, Australia +4 |
| NCT00284986 | Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants | PHASE2 | COMPLETED | 11 | — | — | Nov 18, 2005 | Feb 8, 2007 | Oct 30, 2025 | 1 | United States |
Treatment was considered a success if all of the following conditions were met: Achieved induction of a complete response (CR) within 28 days after first infusion; CR followed by 28 days maintenance of a clinically meaningful response defined as the response that did not require an increase in corticosteroid dose (methylprednisolone doses \>2 milligram/kilogram/day \[mg/kg/d\] or prednisone doses \>2.5 mg/kg/d) for more than 7 consecutive days; Did not require second line/escalation therapy through Study Day 56; and survived 90 study days.
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response \[DCR\]) within 100 days post first infusion.
Responses included complete response (CR), partial response (PR), failure to respond. CR is defined as a complete resolution of graft-versus-host disease (GVHD). PR is defined as improvement in at least one organ by at least one full stage in the absence of progression in any other organ, or resolution of GVHD in at least one organ with a need for additional treatment because of abnormalities persisting in another organ. Failure to respond is defined as progression of GVHD.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive 6 infusions of placebo-matching Prochymal® intravenously (IV) during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® 2x10^6 hMSC/kg | ACTIVE_COMPARATOR | Participants will receive 6 infusions of Prochymal® 2x10\^6 human mesenchymal stem cells (hMSC)/kg IV during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® | ACTIVE_COMPARATOR | Participants who receive standard of care plus treatment with ex vivo cultured adult human mesenchymal stem cells. |
| PROCHYMAL™ | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Prochymal® | DRUG | Prochymal® intravenous infusion. |
| Placebo | OTHER | Placebo-matching Prochymal® intravenous infusion. |
| Corticosteroid | OTHER | Administration will be intravenously as prescribed by the caregiver. |
| Standard of Care for GVHD | DRUG | Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy) |
| Prochymal | DRUG | Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells |
Inclusion Criteria: * Participants must be 18 years to 70 years of age, inclusive * Participants must have received an allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood or administered a donor leukocyte infusion. * Participants must ha...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 11 | PHASE3 | INCA034176, Tacrolimus, Methotrexate, Ruxolitinib, Cyclophosphamide |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |