Back to resultsPilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma
Primary Purpose
Hodgkin's Lymphoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABVD chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologically documented classical Hodgkin lymphoma according to the WHO Classification. Nodular lymphocyte predominant Hodgkin lymphoma is excluded
- No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
- Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans)
- Age ≥ 18
- Patients must have at least one hypermetabolic lesion identifiable on initial PET scan
- LVEF by ECHO or MUGA within institutional normal limits
- Initial laboratory data should be compatible with the administration of standard doses of ABVD chemotherapy
Exclusion Criteria:
- Patient has no known HIV infection
- Patient is non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control
- No other history of lymphoproliferative disorder or granulomatous disease
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Early Stage Disease
Advance Stage Disease
Arm Description
Group A
Group B
Outcomes
Primary Outcome Measures
36-Month Progression-free Survival Rate
Progression-free survival is defined as the length of time from study intervention to disease progression or death
Secondary Outcome Measures
Full Information
NCT ID
NCT00901303
First Posted
April 30, 2009
Last Updated
August 3, 2018
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00901303
Brief Title
Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma
Official Title
Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to lack of accrual.
Study Start Date
October 2008 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
May 23, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to determine the progression-free survival [PFS] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy (3 cycles).
Detailed Description
The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patients showing a complete metabolic response as measured by FDG-PET after one cycle of ABVD. These patients will undergo two more cycles of ABVD chemotherapy, for a total of 3 cycles. Those patients failing to achieve a complete metabolic response as demonstrated by residual FDG avidity will go off study and be treated as per their primary treating physician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Stage Disease
Arm Type
Other
Arm Description
Group A
Arm Title
Advance Stage Disease
Arm Type
Other
Arm Description
Group B
Intervention Type
Drug
Intervention Name(s)
ABVD chemotherapy
Intervention Description
Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle
Primary Outcome Measure Information:
Title
36-Month Progression-free Survival Rate
Description
Progression-free survival is defined as the length of time from study intervention to disease progression or death
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically documented classical Hodgkin lymphoma according to the WHO Classification. Nodular lymphocyte predominant Hodgkin lymphoma is excluded
No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans)
Age ≥ 18
Patients must have at least one hypermetabolic lesion identifiable on initial PET scan
LVEF by ECHO or MUGA within institutional normal limits
Initial laboratory data should be compatible with the administration of standard doses of ABVD chemotherapy
Exclusion Criteria:
Patient has no known HIV infection
Patient is non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control
No other history of lymphoproliferative disorder or granulomatous disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Elstrom, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma
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