Status:
TERMINATED
Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00901303
Start Date
October 1 2008
End Date
May 23 2011
Last Update
August 31 2018
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10021