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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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)].

Participant Flow for 2 periods

Period 1:   Phase I Dose Escalation
    1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue   1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
STARTED   3   4 
COMPLETED   3   1 
NOT COMPLETED   0   3 
Dose reduction due to DLT                0                3 

Period 2:   Phase 2 Dose Expansion
    1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue   1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)].

Baseline Measures
   Gemcitabine + High-dose Chemotherapy + PBSC Rescue 
Overall Participants Analyzed 
[Units: Participants]
 146 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      145  99.3% 
>=65 years      1   0.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      63  43.2% 
Male      83  56.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      23  15.8% 
Not Hispanic or Latino      119  81.5% 
Unknown or Not Reported      4   2.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity   [ Time Frame: 6 months ]

2.  Secondary:   Pulmonary Toxicity (BCNU Pneumonitis)   [ Time Frame: 2 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 2 years ]

4.  Secondary:   Relapse Post-transplant   [ Time Frame: 2 years ]

5.  Secondary:   Survival Measures   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: sarai1@stanford.edu


Publications:

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