18 Years to 75 Years
Accepting Healthy Volunteers?
1. Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma
confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and
2. Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma
(NHL) outside of CNS.
3. Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for
4. Age- Patients must be between the ages of 18 and 75 years.
5. Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30
(≥ 50 for patients ages 60-70).
6. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of
childbearing potential must have a negative serum or urine pregnancy test 10-14 days
prior to registration; in addition, women and men of childbearing potential must
commit to use an effective form of contraception throughout their participation in
this study; appropriate methods of birth control include abstinence, oral
contraceptives, implantable hormonal contraceptives, or double barrier method
(diaphragm plus condom)
7. HIV - Patients must have negative HIV serology.
8. Hepatitis - Patients must have negative HCV serology (unless HBsAb positive patient
has recently received HBV vaccine, in this case HBcAb should be negative). All
patients must be screened for hepatitis B infection before starting treatment. Those
patients who test positive for hepatitis B should be closely monitored for evidence of
active HBV infection and hepatitis during and for several months after rituximab
treatment. PCNSL patients with a history of hepatitis B infection should be treated
with entecavir or lamivudine (physician discretion for choice of drug) as antiviral
prophylaxis to prevent hepatitis B reactivation.
9. Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ
transplantation or ongoing immunosuppressant therapy.
10. Required Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT < 2 x upper limit of
normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet
count ≥ 100,000/mcL