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Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma

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ClinicalTrials.gov Identifier: NCT00569309
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Small Intestine Cancer
Interventions: Biological: Streptococcus pneumoniae
Other: laboratory correlative studies
Other: quality-of-life assessment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Prevnar

The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.

Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)

laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.

quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.


Participant Flow:   Overall Study
    Prevnar
STARTED   30 
COMPLETED   30 
NOT COMPLETED   0 



  Baseline Characteristics

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
Prevnar

The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.

Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)

laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.

quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.


Baseline Measures
   Prevnar 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Full Range)
 51 
 (18 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   13 
Male   17 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      30 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  13.3% 
White      26  86.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   30 


  Outcome Measures

1.  Primary:   Number of Participants Experiencing Immune Reconstitution   [ Time Frame: Up to 2 years ]

2.  Secondary:   Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10)   [ Time Frame: Up to 3 years ]

3.  Secondary:   Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes   [ Time Frame: Up to 3 years ]

4.  Secondary:   Quality of Life, Including Brief Pain Inventory   [ Time Frame: Up to 3 years ]

5.  Secondary:   Quality of Life, Including Fatigue   [ Time Frame: Up to 3 years ]

6.  Secondary:   Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Craig Hofmeister, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-9869
e-mail: Craig.Hofmeister@osumc.edu



Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00569309     History of Changes
Other Study ID Numbers: OSU-07044
First Submitted: December 6, 2007
First Posted: December 7, 2007
Results First Submitted: June 8, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018