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Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01474681
First received: November 15, 2011
Last updated: April 3, 2017
Last verified: March 2017
Results First Received: April 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute 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
Intervention: Biological: HSC835

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Single arm study of HSC835 broken down into 4 subgroups for analyses and 6 subgroups for safety.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SUCBT < 18 Yrs Single umbilical cord blood transplant(SUCBT) less than 18 yrs
SUCBT >= 18 Yrs Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
DUCBT < 18 Yrs Double umbilical cord blood transplant (DUCBT) less than 18 yrs
DUCBT >= 18 Yrs Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs

Participant Flow:   Overall Study
    SUCBT < 18 Yrs   SUCBT >= 18 Yrs   DUCBT < 18 Yrs   DUCBT >= 18 Yrs
STARTED   1   8   3   15 
COMPLETED   1   5   1   9 
NOT COMPLETED   0   3   2   6 
Death                0                3                2                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SUCBT Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
DUCBT Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
Total Total of all reporting groups

Baseline Measures
   SUCBT   DUCBT   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   18   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.3  (17.18)   31.3  (13.75)   32.0  (14.67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  55.6%      6  33.3%      11  40.7% 
Male      4  44.4%      12  66.7%      16  59.3% 


  Outcome Measures
  Show All Outcome Measures

1.  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.   [ Time Frame: 32 days ]

2.  Secondary:   Incidence of Neutrophil Recovery Within 42 Days   [ Time Frame: 42 days ]

3.  Secondary:   Incidence of Platelet Recovery Within Six Months   [ Time Frame: 6 months ]

4.  Secondary:   Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)   [ Time Frame: Day 100 ]

5.  Secondary:   Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year   [ Time Frame: Day 100 and Month 12 ]

6.  Secondary:   Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year   [ Time Frame: Day 100 and Monnth 12 ]

7.  Secondary:   Incidence of Relapse Within One Year   [ Time Frame: Month 12 ]

8.  Secondary:   Overall Survival (OS) Within One Year   [ Time Frame: Month 12 ]

9.  Secondary:   Disease Free Survival (DFS) Within One Year   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01474681     History of Changes
Other Study ID Numbers: CHSC835X2201
Study First Received: November 15, 2011
Results First Received: April 3, 2017
Last Updated: April 3, 2017