CALGB 50801: Phase II Trial of Response-Adapted Therapy Based on Positron Emission of Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL)

Study Status

Open to Enrollment

Study Description

This research is being done in order to improve treatment outcomes in patients diagnosed with bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with radiation treatment. 

The first chemotherapy treatment in this study consists of a combination of four drugs approved by the Food and Drug Administration (FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been found to be effective in treating patients with Hodgkin lymphoma and is considered to be the standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin lymphoma.

A PET scan is an imaging technique that can detect the possibility of significant remaining active cancer. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET scans will be obtained during the course of your therapy. We will evaluate the usefulness of the PET scan to determine whether radiation may be left out in the treatment of your disease if the PET scan shows you have responded to chemotherapy alone.

A small percentage of patients may have disease that is not adequately treated with ABVD and radiation therapy. We hope to identify this group of patients using early PET scans and will change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone) plus radiation therapy.

Treatment Plan:

All patients will receive 2 cycles of ABVD. Patients who achieve a complete response (CR), partial response (PR), or have stable disease (SD)and whose PET scans are negative after 2 cycles of ABVD will receive 4 more cycles of ABVD for a total of 6 cycles. A cycle is 28 days.

Patients who achieve a CR, PR or SD and whose PET scans are positive after 2 cycles of ABVD will receive 4 cycles of escalated BEACOPP followed by radiation therapy. Repeat escalated or standard BEACOPP treatment every 21 days for 4 cycles.

You will be in the study for at least 6 months. You will be asked to return to the clinic for follow-up:

  • Every 3 months for one year
  • Every 6 months for years 2-3
  • Then once a year for a maximum of 10 years from the time you enter the study

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Disease Status and/or Stage

Bulky, Early Stage Hodgkin Lymphoma

Sponsor

CALGB

Key Eligibility

  • Men and women age 18 to 60
  • Bulky Stage I and II Hodgkin Lymphoma
  • May have had one cycle only of ABVD treatment prior to enrolling in study; no other prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma is allowed
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Rebecca Elstrom, MD

Contact


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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