Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma
18 Years
N/A
Both
Hodgkin's Lymphoma
Trial Information
Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival [PFS] at 36 months
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Rebecca Elstrom, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Institutional Review Board
Study ID:
0810010015
NCT ID:
NCT00901303
Start Date:
May 2010
Completion Date:
Related Keywords:
- Hodgkin's Lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Weill Cornell Medical College | New York, New York 10021 |
