CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
HSC835biological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Diagnosis qualifying for double umbilical cord blood transplantation (DUCBT)
  • ✓Absence of recent active mold infection
  • ✓Adequate organ function
  • ✓Availability of eligible donor material
Key exclusion· 4
  • ✕HIV infection
  • ✕Active infection
  • ✕Extensive prior chemotherapy
  • ✕Prior myeloablative allotransplantation or autologous transplant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01474681
NCT01474681Phase 2Completed
CompareCT.gov

A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies

Novartis Pharmaceuticals·interventional·Posted Nov 18, 2011·Updated Dec 30, 2020

In Brief

A Phase 2 clinical trial evaluating HSC835 for Acute Myelocytic Leukemia and 12 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelocytic Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphomas, Large-cell Lymphoma, Lymphoblastic Lymphoma, Burkitt's Lymphoma, High Grade Lymphomas, Mantle-cell Lymphoma, Lymphoplasmacytic Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 18, 2011
Enrollment StartJan 9, 2012
Primary CompletionOct 3, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 14.6 years ago

Interventions

HSC835biological