Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00637832
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed grade 1, 2, or 3 follicular non-Hodgkin lymphoma
* Stage II, III, or IV disease (according to the Ann Arbor staging system)
* CD20-positive disease
* Initial disease bulk ≤ 10 cm
* In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone
* Relapse must have occurred ≥ 6 months after completion of R-chemo
* Relapse that occurred \< 6 months after completion of chemotherapy alone allowed
* Has at least one of the following symptoms requiring initiation of treatment:
* Nodal mass \> 5 cm in its greater diameter
* B symptoms
* Elevated serum lactate dehydrogenase (LDH) or β2-microglobulin
* Involvement of ≥ 3 nodal sites (each with a diameter \> 3 cm)
* Symptomatic splenic enlargement
* Compressive syndrome
* No primary refractory disease
* No large pleural or peritoneal effusions
* No CNS disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 1,000/mm³
* Serum creatinine \< 1.5 times upper limit of normal (ULN)
* Total bilirubin \< 1.5 times ULN
* AST \< 5 times ULN
* No active obstructive hydronephrosis
* No evidence of active infection requiring IV antibiotics
* No advanced heart disease or other serious illness that would preclude study evaluation
* No known HIV infection
* No human anti-mouse antibody (HAMA) reactivity
* No known hypersensitivity to murine antibodies or proteins
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* No other prior malignancy, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior investigational drugs and recovered
* No prior radioimmunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00637832
Study Brief:
Protocol Section:
NCT00637832