Single Umbilical Cord Blood TransplantationPhase 2UCBTNCT01930162
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant
A Phase 2 study testing HSC835 in people with Single Umbilical Cord Blood Transplantation and Non-myeloablative Conditioning, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Single Umbilical Cord Blood Transplantation, Non-myeloablative Conditioning, Acute Lymphocytic Leukemia
- What is being tested?
- HSC835
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2014to 29 Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a diagnosis that qualifies them for UCBT
- Adequate organ function
- Availability of eligible donor material
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Minneapolis, Minnesota, 55455
About this study
Official title: A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
- Conditions
- Single Umbilical Cord Blood Transplantation, Non-myeloablative Conditioning, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Multiple Myeloma
- Being tested
- HSC835
- Keywords
- HSC835, single umbilical cord blood transplantation, non-myeloablative conditioning regimen, Umbilical cord blood, UCB transplantation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSC835Drug
HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
| Study group | Role | What they receive |
|---|---|---|
| HSC835 | Experimental | Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen. Receives: Drug: HSC835 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Graft Failure at Day 42
This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
Measured: 42 days
Secondary outcomes (4)
Incidence of Neutrophil Recovery Within 42 Days
Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L.
Measured: 42 days
Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year
NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.
Measured: 1 year
Incidence of Overall Survival Within One Year
Overall survival is the proportion of patients who were alive at the end of the one year study period.
Measured: 1 year
Incidence of Relapse-free Survival Within One Year
Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study start7 Oct 2014
- Primary completion29 Aug 2016
- Study completion29 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Single Umbilical Cord Blood TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930162
- Sponsor's protocol ID
- CHSC835X2202
- Acronym
- UCBT
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2013
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen
- ClinicalTrials.gov ID
- NCT01930162
- Acronym / sponsor ID
- UCBT / CHSC835X2202
- Conditions
- Single Umbilical Cord Blood Transplantation, Non-myeloablative Conditioning, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Multiple Myeloma
- Keywords
- HSC835, single umbilical cord blood transplantation, non-myeloablative conditioning regimen, Umbilical cord blood, UCB transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 29 Aug 2016 (actual)
- Study completion
- 29 Aug 2016 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSC835 | Experimental | Drug: HSC835Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis that qualifies them for UCBT
- Adequate organ function
- Availability of eligible donor material
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSC835HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC). | Drug | HSC835 |
Primary outcome
Absence of Graft Failure at Day 42
Time frame: 42 days
This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
4 secondary outcomes
Incidence of Neutrophil Recovery Within 42 Days
Time frame: 42 days
Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year
Time frame: 1 year
Incidence of Overall Survival Within One Year
Time frame: 1 year
Incidence of Relapse-free Survival Within One Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSC835 in people with Single Umbilical Cord Blood Transplantation and Non-myeloablative Conditioning, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Graft Failure at Day 42 (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.