Trial Information

Association Between Response to Aggressive Chemotherapy and Doxorubicin Pharmacokinetics in Non Hodgkin's Lymphoma Patients

Aim of the study:

To evaluate the association between response to chemotherapy, the degree of myelosuppression
and the pharmacokinetics of doxorubicin in non-Hodgkin's lymphoma (NHL) patients.

Methods:

Study protocol:

1. At diagnosis

Demographic and clinical parameters be collected (Appendix 1)

2. At course 2:

1. Doxorubicin will be given by 5-7 minutes infusion before the other medications
(Doxorubicin doses will be collected (Appendix 1))

2. Blood will be sampled in course 2, at:

0 minutes 30 minutes 120 minutes 24 hours

Two 2ml EDT tubes will be drawn at each time The tubes will be centrifuged at 3000 RPM for
15 min. Plasma samples will be stored in - 700C

3. At the end of chemotherapy courses the following data will be collected (Appendix 2):

1. Episodes of bone marrow depression (leucopenia, neutropenia) Treatment delays Dose
reductions Neutropenic fever

2. Remission status

[Complete remission (CR) - disappearance of clinical signs and symptoms of NHL along with
normal laboratory and radiological findings].

4. At the end of one year of CR

Remission status

Number of patients: 30