Trial · NCT00134082

Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma

NCT00134082, Phase 1, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2019-02-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma. Trials, record NCT00134082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00134082

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
NCT number: NCT00134082
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 31 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Lymphoma
Interventions: KGEL vaccine, Filgrastim, Rituximab, Cyclophosphamide
First posted: 2005-08-24
Last updated: 2019-02-26
Results first posted: 2019-02-26

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Grade 3-5 Adverse Events	Up to 36 months	Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.
Primary	Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells	Change from 3 months to 6 months	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.
Secondary	Survival	Up to 6 years	Median 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).
Secondary	Days to Neutrophil and Platelet Engraftment	Up to 46 days	Median number of days to absolute neutrophil count (ANC) \>= 500/mcL and platelet count \>=20000/mcL.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Grade 3-5 Adverse Events	Up to 36 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells	Change from 3 months to 6 months	Although the specimens were collected per protocol, they were not interpretable and therefore no data was collected to assess this outcome measure
SECONDARY	Survival	Up to 6 years		months	MEDIAN
SECONDARY	Days to Neutrophil and Platelet Engraftment	Up to 46 days		days	MEDIAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Grade 3-5 Adverse Events	Immunotherapy		6		Participants
Survival	Immunotherapy	Overall survival	31.5	Full Range 12.2 to 70.9	months
Survival	Immunotherapy	Event-free survival	24.1	Full Range 4.9 to 63	months
Days to Neutrophil and Platelet Engraftment	Immunotherapy	Days until ANC >= 500mcL	17	Full Range 10 to 26	days
Days to Neutrophil and Platelet Engraftment	Immunotherapy	Days until Platelet Count >=20000/mcL	21.5	Full Range 10 to 46	days

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Immunotherapy	30
Overall Study	COMPLETED	Immunotherapy	27
Overall Study	NOT COMPLETED	Immunotherapy	3

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Investigations	Immunotherapy	2	30	28
other	Arthralgia	Musculoskeletal and connective tissue disorders	Immunotherapy	3	30	3
other	Bruising	Skin and subcutaneous tissue disorders	Immunotherapy	2	30	3
other	Dizziness	Nervous system disorders	Immunotherapy	3	30	3
other	Erythema	Skin and subcutaneous tissue disorders	Immunotherapy	2	30	3
other	Fatigue	General disorders	Immunotherapy	21	30	26
other	Fever	General disorders	Immunotherapy	3	30	4
other	Headache	General disorders	Immunotherapy	12	30	28
other	Injection site reaction	Skin and subcutaneous tissue disorders	Immunotherapy	30	30	258
other	Leukopenia	Investigations	Immunotherapy	2	30	16

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Immunotherapy	1	30
Total, other adverse events	Immunotherapy	30	30
Total, serious adverse events	Immunotherapy	15	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
P30CA006973	Regional Oncology Research Center	NELSON, WILLIAM GEORGE	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2025	NIH RePORTER
P50CA096888	SPORE in Lymphoma	AMBINDER, RICHARD FREDERICK	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	2002 to 2009	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00134082

GET https://conductscience.org/api/trials/v1/NCT00134082/events?page=2

API reference For AI assistants