Trial Outcomes & Findings for Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease (NCT NCT00388349)
NCT ID: NCT00388349
Last Updated: 2017-06-14
Results Overview
Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
6 months
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Phase I Dose Escalation
STARTED
|
3
|
4
|
|
Phase I Dose Escalation
COMPLETED
|
3
|
1
|
|
Phase I Dose Escalation
NOT COMPLETED
|
0
|
3
|
|
Phase 2 Dose Expansion
STARTED
|
139
|
0
|
|
Phase 2 Dose Expansion
COMPLETED
|
139
|
0
|
|
Phase 2 Dose Expansion
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Phase I Dose Escalation
Dose reduction due to DLT
|
0
|
3
|
Baseline Characteristics
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Baseline characteristics by cohort
| Measure |
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
n=146 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study
Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
Outcome measures
| Measure |
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
n=3 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
n=4 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who completed the study regardless of gemcitabine dose, and had all data points collected.
Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).
Outcome measures
| Measure |
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
n=146 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Pulmonary Toxicity (BCNU Pneumonitis)
|
26 participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants
Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).
Outcome measures
| Measure |
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
n=146 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Overall Survival (OS)
|
87 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants
Reports the percentage of participants that experienced relapse post-transplant.
Outcome measures
| Measure |
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
n=146 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Relapse Post-transplant
|
29 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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
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
Outcome measures
| Measure |
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
n=92 Participants
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|---|
|
Survival Measures
Freedom from Progression (FFP)
|
71 percentage of patients
Interval 61.0 to 81.0
|
—
|
|
Survival Measures
Event-Free Survival (EFS)
|
67 percentage of patients
Interval 57.0 to 77.0
|
—
|
|
Survival Measures
Overall Survival (OS)
|
83 percentage of patients
Interval 75.0 to 91.0
|
—
|
Adverse Events
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Serious events: 31 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
n=146 participants at risk
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|
|
General disorders
Fever
|
1.4%
2/146 • Number of events 2 • 2 years
All events reported.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
3/146 • Number of events 3 • 2 years
All events reported.
|
|
Cardiac disorders
Cardiac ischemia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Ventricular arythmia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Infections and infestations
osteomyelitis
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
General disorders
Failed to engraft
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Veno-occlusive disease
|
1.4%
2/146 • Number of events 2 • 2 years
All events reported.
|
|
Renal and urinary disorders
Progressive liver failure
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.4%
2/146 • Number of events 2 • 2 years
All events reported.
|
|
General disorders
Allergic reaction
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Infections and infestations
Relapse
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
General disorders
Intubated
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
General disorders
Multisystem organ failure
|
1.4%
2/146 • Number of events 2 • 2 years
All events reported.
|
|
Infections and infestations
Neutropenia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Blood and lymphatic system disorders
Discharge
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Respiratory distress
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Infections and infestations
Septic shock
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
General disorders
Fatigue
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Metabolism and nutrition disorders
Metabolic abnormalities
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Tachypenic
|
2.1%
3/146 • Number of events 3 • 2 years
All events reported.
|
|
General disorders
Death
|
1.4%
2/146 • Number of events 21 • 2 years
All events reported.
|
Other adverse events
| Measure |
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
n=146 participants at risk
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Arrhythmias
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Infections and infestations
Bacteremia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Blood and lymphatic system disorders
Friable fascial plane
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Gastrointestinal disorders
Ileus
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Infections and infestations
Candida albicans
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Chest pain
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Respiratory, thoracic and mediastinal disorders
diffusing capacity of the lung for carbon monoxide (DLCO)
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Blood and lymphatic system disorders
Elevated troponin
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Infections and infestations
Neutropenic fever
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Blood and lymphatic system disorders
Nodular infiltrates
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Respiratory, thoracic and mediastinal disorders
Parpneumonic effusion
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.68%
1/146 • Number of events 1 • 2 years
All events reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place