Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy

Inclusion Criteria:

Subjects meeting the following criteria will be eligible for enrollment in the study
(unless excluded):

- ≥60 years old

- Pathologically confirmed NHL.

- Must meet criteria for initiation of treatment; consisting of:

- Aggressive histology, or

- Indolent histology with one of the following markers of large tumor burden (67):

- Any nodal or extranodal tumor mass ≥7cm in greatest dimension

- ≥3 nodal masses that are each ≥3 cm in greatest dimension

- Systemic symptoms

- Cytopenias (leukocytes <1 × 109/L and/or platelets ,100 × 109/L)

- Substantial splenomegaly

- Serous effusion (plural effusion or peritoneal ascites)

- Orbital or epidural involvement

- Ureteral compression

- Leukemic phase (malignant cells ≥5 x 109/L)

- Must be starting a new chemotherapy regimen

- Fluent in English (because not all components of the GA have been validated in other
languages)

- Able to provide informed consent

In addition to the above, subjects meeting the following criteria will be enrolled in the
pre-phase arm of the study, until the accrual target for that arm is reached:

- Age ≥ 70 years OR KPS ≤ 70

- Pathologically confirmed diagnosis of DLBCL, with or without simultaneous or
antecedent indolent lymphoma.

- Previously untreated for DLBCL

- Intended initial treatment to include ≥2 cycles of R-CHOP, R-EPOCH or R-CEPP using
standard doses and schedule.(68, 69) R-CHOP chemoimmunotherapy may be given every 14
days or every 21 days. (4, 70)

Exclusion Criteria:

Subjects meeting the following criteria will be excluded from enrollment in the study:

- Enrollment in a Phase I trial

- Previously enrollment in this study

- Patients scoring ≥ 11 on the BOMC (implying cognitive impairment) will be excluded
since their ability to reliablly complete the questionnairre will be in doubt
Subjects meeting the following criteria will be excluded from enrollment in the
pre-phase arm of the study, but may be included in the GA only arm.

- Contraindication to use of rituximab or prednisone including:

- Uncontrolled diabetes mellitus

- Systemic fungal infection

- Evidence of active hepatitis B infection (i.e. patients testing positive hepatitis B
surface antigen or viral DNA by PCR analysis) will be excluded. Patients with
evidence of past infection without active viremia (i.e. positive hepatitis B core
antibody, negative hepatitis B surface antigen and negative hepatitis B DNA PCR) will
be treated with entecavir as per institutional guidelines and may be included in the
study.

- History of any serious adverse reaction to either a corticosteroid or rituximab not
including rituximab infusion reactions ≤ Grade 3.

- Patients enrolled on another clinical trial which prohibits the use of pre-phase
therapy or any of its components.