NCT00901303

Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma

Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	ABVD chemotherapy	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

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-06-01
• Completion: 2011-05-23
• First posted: 2009-05-13
• Last updated: 2018-08-31
• Results posted: 2018-08-31

Locations

1 site across 1 country: United States