Trial · NCT00388349

Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

NCT00388349, Phase 2, Completed, Stanford University; results first posted 2017-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease. Trials, record NCT00388349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00388349

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Trial

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

Title: Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
NCT number: NCT00388349
Status: Completed
Phases: Phase 2
Enrollment: 146 participants, actual
Lead sponsor: Stanford University
Conditions: Hodgkin Disease, Hodgkin's Lymphoma, Lymphoma
Interventions: Gemcitabine, Vinorelbine, Carmustine, Etoposide, Cyclophosphamide, Autologous HCT
First posted: 2006-10-16
Last updated: 2017-06-14
Results first posted: 2017-06-14

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity	6 months	Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
Secondary	Pulmonary Toxicity (BCNU Pneumonitis)	2 years	Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).
Secondary	Overall Survival (OS)	2 years	Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).
Secondary	Relapse Post-transplant	2 years	Reports the percentage of participants that experienced relapse post-transplant.
Secondary	Survival Measures	2 years	Reports the survival measures: * Freedom from progression (FFP) * Event-free survival (EFS) * Overall survival (OS) EFS and OS were estimated by Kaplan-Meier method Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity	6 months	7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study	participants	NUMBER
SECONDARY	Pulmonary Toxicity (BCNU Pneumonitis)	2 years	Patients who completed the study regardless of gemcitabine dose, and had all data points collected.	participants	NUMBER
SECONDARY	Overall Survival (OS)	2 years	All participants	percentage of participants	NUMBER
SECONDARY	Relapse Post-transplant	2 years	All participants	percentage of participants	NUMBER
SECONDARY	Survival Measures	2 years	Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity	1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue		0		participants
Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity	1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue		3		participants
Pulmonary Toxicity (BCNU Pneumonitis)	Gemcitabine + High-dose Chemotherapy + PBSC Rescue		26		participants
Overall Survival (OS)	Gemcitabine + High-dose Chemotherapy + PBSC Rescue		87		percentage of participants
Relapse Post-transplant	Gemcitabine + High-dose Chemotherapy + PBSC Rescue		29		percentage of participants
Survival Measures	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	Freedom from Progression (FFP)	71	95% Confidence Interval 61 to 81	percentage of patients
Survival Measures	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	Event-Free Survival (EFS)	67	95% Confidence Interval 57 to 77	percentage of patients
Survival Measures	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	Overall Survival (OS)	83	95% Confidence Interval 75 to 91	percentage of patients

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Phase I Dose Escalation	STARTED	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	3
Phase I Dose Escalation	STARTED	1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	4
Phase I Dose Escalation	COMPLETED	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	3
Phase I Dose Escalation	COMPLETED	1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1
Phase I Dose Escalation	NOT COMPLETED	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	0
Phase I Dose Escalation	NOT COMPLETED	1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	3
Phase 2 Dose Expansion	STARTED	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	139
Phase 2 Dose Expansion	STARTED	1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	0
Phase 2 Dose Expansion	COMPLETED	1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	139
Phase 2 Dose Expansion	COMPLETED	1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events39

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	Abdominal pain	Gastrointestinal disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Arrhythmias	Cardiac disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Bacteremia	Infections and infestations	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Friable fascial plane	Blood and lymphatic system disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Ileus	Gastrointestinal disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Bowel obstruction	Gastrointestinal disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Candida albicans	Infections and infestations	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Chest pain	Cardiac disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	diffusing capacity of the lung for carbon monoxide (DLCO)	Respiratory, thoracic and mediastinal disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1
other	Dyspnea on exertion	Respiratory, thoracic and mediastinal disorders	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	1	146	1

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Total, other adverse events	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	17	146
Total, serious adverse events	Gemcitabine + High-dose Chemotherapy + PBSC Rescue	31	146

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20197102	BACKGROUND

Source PubMed

Grants1

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
K23AI052413	GVHD and Relapse:Ex-Vivo Expanded Allogeneic Therapy	ARAI, SALLY	STANFORD UNIVERSITY	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2003 to 2007

Source NIH RePORTER

Trial comparisons1

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

Comparison
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue vs 1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue: Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

Source Trial comparisons

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/NCT00388349

GET https://conductscience.org/api/trials/v1/NCT00388349/events?page=2

API reference For AI assistants