Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University Hospital Plymouth NHS Trust
OBJECTIVES: Primary * To evaluate the rates of overall response (complete response \[CR\], CR unconfirmed \[CRu\], and partial response). Secondary * To evaluate the rates of CR and CRu. * To determine the median time to progression. * To determine the median overall survival. * To evaluate the toxicity and tolerability. * To compare the responses to these treatment regimens with those from first line therapy. * To compare the quality of life. OUTLINE: This is a randomized, open-label, parallel group, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I (CHOP): Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Arm I has been discontinued April 2012 on recommendation of the DMC. * Arm II (CHOP with bortezomib): Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5. In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment. After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
