Treatment of Relapsed or Primary Refractory Hodgkin Lymphoma with High-Dose CBV Followed by Autologous Peripheral Blood Progenitor Cell Rescue

Principal Investigator: Robert M. Rifkin, MD, FACP

Protocol Number: RMBMT-106

Major Objectives

• To describe the resource utilization, hematologic recovery, and hospitalizations during the first 28 days post-transplant.
• To describe progression-free survival and overall survival over 2 years post-transplant.

Patient Selection

Inclusion Criteria:

1. Be 18 years of age or older.
2. Have histologically proven Hodgkin’s Lymphoma in one of the following categories:
   • Refractory to primary therapy
   • Recurrent disease
3. Be practicing effective birth control.
4. Have an ECOG performance status of 0 or 1 with a life expectancy of at least 6 months.
5. Have major end organs (heart, lungs, liver, kidneys) assessed and deemed adequate to withstand the effects of high-dose therapy planned for this protocol. The method of assessment and determination of adequacy will be by site specific policies as on file with the overseeing IRB.
6. Have an adequate number of hematopoietic stem cells for transplant collected by mobilization and apheresis (minimum of 2.0 X10⁶ CD 34+ cells/kg) or marrow harvesting (minimum of 1.0 X10⁶ CD 34+ cells/kg) and stored by cryopreservation.
7. Have given voluntary informed consent.

Exclusion Criteria:

1. Have a condition that makes them unacceptable for high-dose therapy.
2. Are female and are pregnant, lactating, or have a positive pregnancy test.
3. Have a history of previous malignancy except non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for >5years.
4. Are HIV positive.