Trial Information

Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell Non-Hodgkin's Lymphoma

OBJECTIVES:

- Compare the effects of mobilization therapy with or without rituximab on hematopoietic
stem cells, B and T lymphocytes, and natural killer cells in patients with advanced or
recurrent B-cell non-Hodgkin's lymphoma.

- Compare the effects of B-lymphocyte purging using concurrent rituximab and mobilization
therapy vs a CD34+ cell enrichment device on hematopoietic stem cells, B and T
lymphocytes, and natural killer cells in the peripheral blood stem cell (PBSC)
infusates.

- Compare the effect of these purging regimens on tumor cell content of PBSC infusates.

- Compare the effects of these regimens on myeloid and lymphoid engraftment after
high-dose chemotherapy and autologous PBSC infusion in these patients.

- Compare post-transplantation infection complications in patients treated with these
regimens.

- Compare the response and relapse-free survival of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive mobilization therapy comprising rituximab IV over 2-5 hours on
days 1, 8, and 15 and cyclophosphamide IV over 3-6 hours on day 16. Beginning 36-48
hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF)
subcutaneously (SC) daily until blood counts recover. Patients then undergo peripheral
blood stem cell (PBSC) collection.

After completion of PBSC collection, patients receive high-dose chemotherapy comprising
carmustine IV on days -7 to -3 and etoposide IV and cisplatin IV for 3 days during days -7
to -3. Patients may undergo involved-field radiotherapy to active or previously bulky (more
than 5 cm) tumors daily for 7-10 days.

Patients receive unmanipulated PBSCs on day 0. Patients receive G-CSF SC daily beginning 4
hours after completion of PBSC infusion and continuing until neutrophil engraftment.

- Arm II: Patients receive mobilization therapy comprising cyclophosphamide and G-CSF and
high-dose chemotherapy comprising carmustine, etoposide, and cisplatin as in arm I.
Patients may also undergo involved-field radiotherapy as in arm I. Patients receive
CD34 cell-enriched PBSC on day 0 followed by G-CSF as in arm I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 years.