NCT01474681

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 12, 2017

Completed
Last Updated

December 30, 2020

Status Verified

March 1, 2019

Enrollment Period

4.7 years

First QC Date

November 15, 2011

Results QC Date

April 3, 2017

Last Update Submit

December 9, 2020

Conditions

Acute Myelocytic LeukemiaAcute Lymphocytic LeukemiaChronic Myelogenous LeukemiaMyelodysplastic SyndromeChronic Lymphocytic LeukemiaMarginal Zone LymphomaFollicular LymphomasLarge-cell LymphomaLymphoblastic LymphomaBurkitt's LymphomaHigh Grade LymphomasMantle-cell LymphomaLymphoplasmacytic Lymphoma

Keywords

hematologic malignanciesleukemialymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.

    32 days

Secondary Outcomes (8)

  • Incidence of Neutrophil Recovery Within 42 Days

    42 days

  • Incidence of Platelet Recovery Within Six Months

    6 months

  • Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)

    Day 100

  • Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year

    Day 100 and Month 12

  • Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year

    Day 100 and Monnth 12

  • +3 more secondary outcomes

Study Arms (1)

HSC835

EXPERIMENTAL

HSC835 infusion

Biological: HSC835

Interventions

HSC835BIOLOGICAL
HSC835

Eligibility Criteria

Age10 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with a diagnosis that qualifies them for a DUCBT
  • Absence of recent active mold infection
  • Adequate organ function
  • Availability of eligible donor material

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Minneapolis, Minnesota, 55455, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic SyndromesLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularDendritic Cell Sarcoma, InterdigitatingBurkitt LymphomaLymphoma, Non-HodgkinLymphoma, Mantle-CellHematologic NeoplasmsLeukemiaLymphoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLymphoma, B-CellHistiocytic Disorders, MalignantHistiocytosisEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeoplasms by Site

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 18, 2011

Study Start

January 9, 2012

Primary Completion

October 3, 2016

Study Completion

October 3, 2016

Last Updated

December 30, 2020

Results First Posted

May 12, 2017

Record last verified: 2019-03

Locations

US(1)