Phase 2
N=27
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
Acute Myelocytic Leukemia · Acute Lymphocytic Leukemia · Chronic Myelogenous Leukemia · Myelodysplastic Syndrome · Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01474681 ↗Enrolled (actual)
27
Serious AEs
92.6%
Results posted
May 2017
Primary outcome: Primary: Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT. — 0; 0; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HSC835 (Biological)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT. |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Incidence of Neutrophil Recovery Within 42 Days |
1; 8; 3; 15 | — |
| SECONDARY Incidence of Platelet Recovery Within Six Months |
1; 6; 2; 11 | — |
| SECONDARY Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only) |
0; 6; 3; 3; 0; 6 | — |
| SECONDARY Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year |
0; 1; 1; 3; 0; 1 | — |
| SECONDARY Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year |
0; 5; 3; 8; 0; 1 | — |
| SECONDARY Incidence of Relapse Within One Year |
0; 2; 1; 0 | — |
| SECONDARY Overall Survival (OS) Within One Year |
1; 5; 1; 9 | — |
| SECONDARY Disease Free Survival (DFS) Within One Year |
1; 5; 1; 9 | — |
Summary
This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis that qualifies them for a DUCBT
- Absence of recent active mold infection
- Adequate organ function
- Availability of eligible donor material
Exclusion Criteria
- Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
- Human immunodeficiency virus (HIV) infection
- Active infection
- Extensive prior chemotherapy
- Prior myeloablative allotransplantation or autologous transplant.
Data sourced from ClinicalTrials.gov (NCT01474681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.