Trial Outcomes & Findings for Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor (NCT NCT01326104)

Last Updated: 2025-04-27

Results Overview

PFS is defined as time interval from date of first DC vaccine to date of progression (death is also treated as progression) or censoring, whichever happens first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

up to 12 months

Results posted on

2025-04-27

Participant Flow

Thirty-six patients were assessed for eligibility in the Phase II trial. Ten subjects were excluded; seven did not meet eligibility and three declined participation prior to allocation to intervention arm.

Participant milestones

Participant milestones
Measure	Group A High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.	Group B NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.
Overall Study STARTED	7	19
Overall Study COMPLETED	7	15
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.	Group B NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.
Overall Study progressed prior to vaccine	0	2
Overall Study unable to make vaccine	0	2

Baseline Characteristics

Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=7 Participants High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.	Group B n=15 Participants NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.	Total n=22 Participants Total of all reporting groups
Age, Continuous	15 years n=5 Participants	10 years n=7 Participants	12.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

PFS is defined as time interval from date of first DC vaccine to date of progression (death is also treated as progression) or censoring, whichever happens first.

Outcome measures

Outcome measures
Measure	Group A n=7 Participants High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.	Group B n=15 Participants NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.
12 Month Progression-free Survival (PFS-12)	215 Days Interval 110.0 to In Group A, we have insufficient participants with events.	69 Days Interval 41.0 to 151.0

SECONDARY outcome

Timeframe: best overall radiographic response through duration on study (up to 60 months)

Radiographic response will be assessed as a percentage change in tumor size from pre-treatment (baseline) MRI scans of the brain and spine obtained with and without contrast. Evaluation will be based on the NCI-endorsed, World Health Organization RECIST criteria and using a modified version of the MacDonald criteria (complete response, partial response, stable disease, progressive disease or not assessible).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline compared to 6 weeks post vaccine #1 and longitudinal measures through overall survival (up to 60 months)

Peripheral blood will be used to compare pre-therapy lymphocyte function to defined intervals after each immunization. Blood will be obtained for immunologic monitoring prior to non-mobilized leukapheresis, prior to immunotherapy, 1 day post Vaccine #1, 4 (+/- 1) days post Vaccine #1, weekly post Vaccine #1 for six weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline compared to 6 weeks post vaccine #1 and longitudinal measures through overall survival (up to 60 months)

We will measure serum cytokines pre and post therapy. Blood will be obtained for immunologic monitoring prior to non-mobilized leukapheresis, prior to immunotherapy, 1 day post Vaccine #1, 4 (+/- 1) days post Vaccine #1, weekly post Vaccine #1 for six weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline compared to 6 weeks post vaccine #1 and longitudinal measures through overall survival (up to 60 months)

We will conduct flow cytometry from patient samples. Blood will be obtained for immunologic monitoring prior to non-mobilized leukapheresis, prior to immunotherapy, 1 day post Vaccine #1, 4 (+/- 1) days post Vaccine #1, weekly post Vaccine #1 for six weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Kaplan-Meier estimator will be used to describe length of overall survival from initiation of vaccine #1 for both Groups A and B.

Outcome measures

Outcome data not reported

Adverse Events

Group A

Serious events: 4 serious events

Other events: 7 other events

Deaths: 6 deaths

Group B

Serious events: 5 serious events

Other events: 19 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Group A n=7 participants at risk High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.	Group B n=19 participants at risk NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs. TTRNA-xALT: TTRNA-xALT 3 x 10\^7/kg by intravenous injection once. TTRNA-DCs: TTRNA-DCs 1 x 10\^7 by intradermal injection every 2 weeks for 3 total doses.
Ear and labyrinth disorders Hearing impaired	28.6% 2/7 • Number of events 2 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	0.00% 0/19 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	10.5% 2/19 • Number of events 2 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Vascular disorders Hypotension	28.6% 2/7 • Number of events 2 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	0.00% 0/19 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	0.00% 0/19 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	5.3% 1/19 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Cardiac disorders Cardiac Arrest	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	5.3% 1/19 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
General disorders Pain	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	10.5% 2/19 • Number of events 2 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Infections and infestations Colitis, Infectious	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	5.3% 1/19 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Metabolism and nutrition disorders Acidosis	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	5.3% 1/19 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Nervous system disorders Hydrocephalus	0.00% 0/7 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	5.3% 1/19 • Number of events 2 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Cardiac disorders Tachycardia	14.3% 1/7 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	0.00% 0/19 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.
Metabolism and nutrition disorders Hyperbilirubinemia	14.3% 1/7 • Number of events 1 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.	0.00% 0/19 • There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy. An "AE" will be defined as any adverse change from the subject's pre-treatment baseline condition, including any clinical or laboratory test abnormality that occurs during the course of research after treatment has started. A summary of recorded AEs will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution.

Other adverse events

Additional Information

Kristine Wynne

University of Florida

Phone: 352-273-9727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place