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Details for trial 13NHL-07-3

Description:	Rituximab Plus CHOP Given Every 15 days with Sargramostim in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Anil Tulpule	M.D.

Data Management

Name	Title
Nancy Berman	R.N.
Yvonne Avila	D.M.
Jeff Hergesheimer	D.M.

You may participate in this study if:

	Requirement
1	Previously untreated, histologically or cytologically documented diffuse large B-cell NHL.
2	CD20 positive lymphoma.
3	All stages of disease.
4	Measurable or non-measurable disease.
5	At least 18 years of age.
6	KPS at least 50% (ECOG PS 0-2).
7	Expected survival at least 3 months.
8	AGC >1.0 and platelets >75,000 unless secondary to lymphomatous involvement of BM. All patients must be off colony stimulating factor treatment at least 24 hours prior to institution of cycle 1 chemotherapy.
9	Bilirubin < / = 2.0, unless elevated secondary to lymphomatous involvement of liver or biliary system. For bilirubin >3.0 due to hepatic involvement, initial dose of doxorubicin will be decreased by 50%, and initial dose of vincristine will be omitted. SGOT <5 x uln.
10	Creatinine <2.0 or CrCl 60 ml/min (unless secondary to renal involvement by lymphoma).
11	LVEF = / > inst limits of normal, as assessed by nuclear scan or echocardiogram obtained within 6 weeks of registration.
12	Concurrent RT with or without steroids for emergency conditions secondary to lymphoma, i.e., CNS tumor, cord compression, etc., will be permitted, provided that additional measurable or evaluable sites of lymphomatous disease are present at study entry.
13	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	Second active tumor, other than non-melanomatous skin cancer or cervical carcinoma in-situ.
2	Primary CNS lymphoma, including parenchymal brain or spinal cord lymphoma.
3	Unable to comply with protocol requirements, or unable to provide adequate IC in PI’s opinion.
4	Serious, on-going non-malignant disease or infection, which, in MD’s/sponsor’s opinion, would compromise other protocol objectives.
5	Major surgery, other than diagnostic surgery, within 4 weeks.
6	History of prior treatment with Rituximab within 12 months. Patients treated with Rituximab >12 months earlier are eligible only if it was given for indications other than treatment of aggressive lymphoma.
7	History of prior cytotoxic chemotherapy or RT for this lymphoma.
8	History of cutaneous or muco-cutaneous reactions or disease in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for 2 days or more.
9	Pregnant or nursing women. Female patients must have negative pregnancy test within 72 hours of entering into study. Both men and women will be included, and if of childbearing potential, must use adequate contraception for the duration of treatment. Women must avoid pregnancy and men avoid fathering children while in the study.
10	Any acute intercurrent infection that may interfere with planned protocol treatment.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.