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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT01234766
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated, histologically confirmed follicular lymphoma classification grade 1, 2 or 3a
* Ann Arbor stages of II to IV with either symptomatic or bulky disease (\>5 cm); or disease progression
* 18 years of age or older
* ECOG PS \<2
* Normal organ and marrow function defined as below:
Absolute neutrophil count (ANC) \>= 1,000/mm3 Platelet count \>=100,000/mm3 Patients with ANC less than 1,000/mm3 and/or platelets below 100,000/mm3 are still eligible for study entry as long as there is \>50% bone marrow involvement with lymphoma
* Adequate hepatic function
* Adequate renal function
* Measureable disease with at least one lesion measuring \> 2cm in its greatest transverse diameter
* Female subjects of childbearing potential must have a negative pregnancy test (urine or serum b-HCG) at screening and within 1 week prior to the start of treatment with Y-90 ibritumomab tiuxetan
* Voluntary written informed consent must be given before performance of any study-related procedure
Exclusion Criteria:
* Prior chemotherapy, immunotherapy, or monoclonal antibody therapy
* Receiving any other investigational agents
* Primary CNS lymphoma
* Known HIV
* Treatment with therapeutic doses of systemic steroids within 4 weeks of beginning study treatment (cycle 1, day -7); topical use of corticosteroids and systemic replacement of corticosteroids for adrenal insufficiency are allowed
* Malignant pleural, pericardial or peritoneal effusions
* Known history of myelodysplastic syndrome (MDS) or found to have MDS
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would, in the judgment of the investigator, limit compliance with study requirements
* Pregnant or lactating female subjects
* Concurrent active malignancy other than lymphoma or history of invasive malignancy within the past 5 years, except completely excised, non-melanoma skin cancer
* Known Hepatitis B and/or Hepatitis C Infection
* Any other condition, that in the judgment of the investigator places the patient at unacceptable risk if he/she were to participant in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01234766
Study Brief:
Protocol Section:
NCT01234766