Trial Outcomes & Findings for Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma (NCT NCT00569309)

Last Updated: 2018-03-12

Results Overview

Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV \& EBV tetramer responses after autologous transplant for myeloma

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2018-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevnar n=30 Participants 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.
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Prevnar n=30 Participants 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.
Number of Participants Experiencing Immune Reconstitution	30 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Inadequate material collected to perform these assays

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Quality of Life surveys were not completed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Not all patients data was available due to incomplete surveys

The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.

Outcome measures

Outcome measures
Measure	Prevnar n=13 Participants 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.
Quality of Life, Including Brief Pain Inventory	2.8 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Up to 3 years

Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.

Outcome measures

Outcome measures
Measure	Prevnar n=30 Participants 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.
Quality of Life, Including Fatigue	2.55 units on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data was not collect and analyzed for reporting purposes

Outcome measures

Outcome data not reported

Adverse Events

Prevnar

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prevnar n=30 participants at risk 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. 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)
Infections and infestations Infection with unknown ANC	10.0% 3/30 • Number of events 3
General disorders Fever with unknown origin	10.0% 3/30 • Number of events 3
Gastrointestinal disorders Colitis	6.7% 2/30 • Number of events 2

Additional Information

Craig Hofmeister, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place