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

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ClinicalTrials.gov Identifier: NCT00388349
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sally Arai, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hodgkin Disease
Hodgkin's Lymphoma
Lymphoma
Interventions Drug: Gemcitabine
Drug: Vinorelbine
Drug: Carmustine
Drug: Etoposide
Drug: Cyclophosphamide
Procedure: Autologous HCT
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue 1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description 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)]. 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)].
Period Title: Phase I Dose Escalation
Started 3 4
Completed 3 1
Not Completed 0 3
Reason Not Completed
Dose reduction due to DLT             0             3
Period Title: Phase 2 Dose Expansion
Started 139 [1] 0 [2]
Completed [3] 139 0
Not Completed 0 0
[1]
Includes the three phase 1 participants who received 1250 mg/m2 gemcitabine (MTD)
[2]
No participants were treated in Phase 2 at 1500 mg/m2 gemcitabine (MTD exceeded)
[3]
# pts @ 1250 mg/m^2 Gemzar in Phase 2 doesn't include the 4 pts @ 1500 mg/m2 Gemzar in Phase 1.
Arm/Group Title Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description 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 Number of Baseline Participants 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
<=18 years
0
   0.0%
Between 18 and 65 years
145
  99.3%
>=65 years
1
   0.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Female
63
  43.2%
Male
83
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Hispanic or Latino
23
  15.8%
Not Hispanic or Latino
119
  81.5%
Unknown or Not Reported
4
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
   4.8%
Native Hawaiian or Other Pacific Islander
3
   2.1%
Black or African American
3
   2.1%
White
105
  71.9%
More than one race
1
   0.7%
Unknown or Not Reported
27
  18.5%
1.Primary Outcome
Title Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
Hide Description Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study
Arm/Group Title 1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue 1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue
Hide Arm/Group Description:
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)].
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 Number of Participants Analyzed 3 4
Measure Type: Number
Unit of Measure: participants
0 3
2.Secondary Outcome
Title Pulmonary Toxicity (BCNU Pneumonitis)
Hide Description Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study regardless of gemcitabine dose, and had all data points collected.
Arm/Group Title Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description:
Gemcitabine (1250 or 1500 mg/m2) 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 Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
26
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description:
Gemcitabine (1250 or 1500 mg/m2) 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 Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
87
4.Secondary Outcome
Title Relapse Post-transplant
Hide Description Reports the percentage of participants that experienced relapse post-transplant.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description:
Gemcitabine (1250 or 1500 mg/m2) 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 Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
29
5.Secondary Outcome
Title Survival Measures
Hide Description

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

Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description:
Gemcitabine 1250 mg/m2 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 Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Freedom from Progression (FFP)
71
(61 to 81)
Event-Free Survival (EFS)
67
(57 to 77)
Overall Survival (OS)
83
(75 to 91)
Time Frame 2 years
Adverse Event Reporting Description All events reported.
 
Arm/Group Title Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Hide Arm/Group Description 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)].
All-Cause Mortality
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Affected / at Risk (%) # Events
Total   31/146 (21.23%)    
Blood and lymphatic system disorders   
Discharge   1/146 (0.68%)  1
Cardiac disorders   
Cardiac ischemia  [1]  1/146 (0.68%)  1
Ventricular arythmia  [2]  1/146 (0.68%)  1
Supraventricular tachycardia   1/146 (0.68%)  1
Veno-occlusive disease   2/146 (1.37%)  2
Respiratory distress   1/146 (0.68%)  1
Tachypenic   3/146 (2.05%)  3
Gastrointestinal disorders   
Constipation  [3]  3/146 (2.05%)  3
Bowel obstruction   2/146 (1.37%)  2
General disorders   
Fever  [4]  2/146 (1.37%)  2
Failed to engraft   1/146 (0.68%)  1
Allergic reaction   1/146 (0.68%)  1
Intubated   1/146 (0.68%)  1
Multisystem organ failure   2/146 (1.37%)  2
Fatigue  [5]  1/146 (0.68%)  1
Death   2/146 (1.37%)  21
Infections and infestations   
osteomyelitis   1/146 (0.68%)  1
Relapse   1/146 (0.68%)  1
Neutropenia   1/146 (0.68%)  1
Septic shock   1/146 (0.68%)  1
Metabolism and nutrition disorders   
Metabolic abnormalities   1/146 (0.68%)  1
Renal and urinary disorders   
Progressive liver failure   1/146 (0.68%)  1
Indicates events were collected by systematic assessment
[1]
myocardial infraction
[2]
includes Left ventricular systolic dysfunction
[3]
Includes severe
[4]
persistent fevers included
[5]
including severe
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gemcitabine + High-dose Chemotherapy + PBSC Rescue
Affected / at Risk (%) # Events
Total   17/146 (11.64%)    
Blood and lymphatic system disorders   
Friable fascial plane   1/146 (0.68%)  1
Elevated troponin   1/146 (0.68%)  1
Nodular infiltrates  [1]  1/146 (0.68%)  1
Cardiac disorders   
Arrhythmias   1/146 (0.68%)  1
Chest pain   1/146 (0.68%)  1
Ventricular tachycardia   1/146 (0.68%)  1
Gastrointestinal disorders   
Abdominal pain   1/146 (0.68%)  1
Ileus   1/146 (0.68%)  1
Bowel obstruction   1/146 (0.68%)  1
Infections and infestations   
Bacteremia   1/146 (0.68%)  1
Candida albicans   1/146 (0.68%)  1
Neutropenic fever   1/146 (0.68%)  1
Renal and urinary disorders   
Urinary tract infection   1/146 (0.68%)  1
Respiratory, thoracic and mediastinal disorders   
diffusing capacity of the lung for carbon monoxide (DLCO)   1/146 (0.68%)  1
Dyspnea on exertion   1/146 (0.68%)  1
Parpneumonic effusion   1/146 (0.68%)  1
Pneumonia   1/146 (0.68%)  1
Indicates events were collected by systematic assessment
[1]
Located in right and left lower lobes
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sally Arai
Organization: Stanford University
Phone: 650-723-0822
Responsible Party: Sally Arai, Stanford University
ClinicalTrials.gov Identifier: NCT00388349     History of Changes
Other Study ID Numbers: IRB-13511
1K23AI052413-01A1 ( U.S. NIH Grant/Contract )
BMT135 ( Other Identifier: OnCore )
First Submitted: October 12, 2006
First Posted: October 16, 2006
Results First Submitted: January 9, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017