A Phase II Study of Bryostatin 1 and Vincristine in Patients With Low or Intermediate Grade Non-Hodgkin's Lymphoma Progressing or Relapsing After a Prior Autologous Bone Marrow or Stem Cell Transplant
I. To evaluate response rate when bryostatin 1 is given in combination with vincristine in
patients with low and intermediate grade non-Hodgkin's lymphoma who have progressed or
relapsed following an autologous bone marrow or stem cell transplant.
II. To determine if blunting of apoptotic response (with two or more consecutive apoptotic
fractions) following treatment using annexin V staining of peripheral blood CD5+ and CD19+
lymphocytes by flow cytometry is predictive of outcome (i.e. lack of clinical response).
III. To prospectively evaluate the incidence of > grade 3 myelotoxicity with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2
and 16. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients without disease progression after 6 courses may continue therapy with bryostatin 1
IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23. Courses repeat every
6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 2-5 years, and then
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response in terms of sustained increase in apoptotic fractions
Up to 5 years
Case Western Reserve University
United States: Food and Drug Administration
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