Trial Outcomes & Findings for Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma (NCT NCT00134082)
NCT ID: NCT00134082
Last Updated: 2019-02-26
Results Overview
Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2019-02-26
Participant Flow
One participant was a screen failure.
Participant milestones
| Measure |
Immunotherapy
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Immunotherapy
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immunotherapy
n=30 Participants
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=30 Participants
|
|
Age, Continuous
|
39.5 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsNumber of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.
Outcome measures
| Measure |
Immunotherapy
n=30 Participants
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Number of Participants With Grade 3-5 Adverse Events
|
6 Participants
|
PRIMARY outcome
Timeframe: Change from 3 months to 6 monthsPopulation: Although the specimens were collected per protocol, they were not interpretable and therefore no data was collected to assess this outcome measure
Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells. Increase in frequency is defined as at least one order of magnitude higher than baseline measurement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 yearsMedian number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival).
Outcome measures
| Measure |
Immunotherapy
n=30 Participants
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Survival
Overall survival
|
31.5 months
Interval 12.2 to 70.9
|
|
Survival
Event-free survival
|
24.1 months
Interval 4.9 to 63.0
|
SECONDARY outcome
Timeframe: Up to 46 daysMedian number of days to absolute neutrophil count (ANC) \>= 500/mcL and platelet count \>=20000/mcL.
Outcome measures
| Measure |
Immunotherapy
n=30 Participants
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Days to Neutrophil and Platelet Engraftment
Days until ANC >= 500mcL
|
17 days
Interval 10.0 to 26.0
|
|
Days to Neutrophil and Platelet Engraftment
Days until Platelet Count >=20000/mcL
|
21.5 days
Interval 10.0 to 46.0
|
Adverse Events
Immunotherapy
Serious events: 15 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Immunotherapy
n=30 participants at risk
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Infections and infestations
Influenza A
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Gastrointestinal disorders
Nausea and vomiting
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Infections and infestations
Febrile neutropenia
|
30.0%
9/30 • Number of events 9 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Investigations
Cytopenia
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
General disorders
Rigors
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Vascular disorders
Thrombus
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Infections and infestations
Infection, not specified
|
3.3%
1/30 • Number of events 1 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
Other adverse events
| Measure |
Immunotherapy
n=30 participants at risk
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.
Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.
Rituximab: 375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0.
|
|---|---|
|
Investigations
Anemia
|
6.7%
2/30 • Number of events 28 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
3/30 • Number of events 3 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.7%
2/30 • Number of events 3 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Number of events 3 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
2/30 • Number of events 3 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
General disorders
Fatigue
|
70.0%
21/30 • Number of events 26 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
General disorders
Fever
|
10.0%
3/30 • Number of events 4 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
General disorders
Headache
|
40.0%
12/30 • Number of events 28 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
30/30 • Number of events 258 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Investigations
Leukopenia
|
6.7%
2/30 • Number of events 16 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Investigations
Lymphopenia
|
13.3%
4/30 • Number of events 14 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30 • Number of events 4 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Investigations
Neutropenia
|
96.7%
29/30 • Number of events 110 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Musculoskeletal and connective tissue disorders
Pain - knee
|
6.7%
2/30 • Number of events 2 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Musculoskeletal and connective tissue disorders
Pain - thigh
|
13.3%
4/30 • Number of events 4 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Nervous system disorders
Paresthesia
|
13.3%
4/30 • Number of events 4 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • Number of events 2 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.3%
4/30 • Number of events 5 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
6/30 • Number of events 8 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Investigations
Thrombocytopenia
|
13.3%
4/30 • Number of events 31 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Nervous system disorders
Weakness
|
10.0%
3/30 • Number of events 3 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
6.7%
2/30 • Number of events 2 • Up to 3 years
The following adverse events only were collected on this study: * All adverse events attributed to the vaccine * All grade 3-5 nonhematologic toxicities until 30 days post last dose of vaccine * Any hospitalization or death until 30 days post last dose of vaccine * Grade 3-4 neutropenia until 1 year post completion of high-dose cyclophosphamide
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place