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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT01068392
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed marginal zone B-cell lymphomas
* Failure to achieve a clinical benefit (≥SD) with the initial treatment, or recurrent disease
* Performance status (ECOG) ≤2
* Age ≥ 20
* At least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
* Adequate kidney functions defined as; Cr \< 2.0 mg% or Ccr \> 60 ml/min
* Adequate liver functions defined as; Transaminases \< 3 X upper normal values; Bilirubin \< 2 mg%
* Adequate bone marrow functions defined as; ANC \> 1500/㎕, platelet \> 75000/㎕
* Ann Arbor stage III or IV
* Ann Arbor stage I or II, which is not adequate for RT or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal LN with stomach involvement)
* Written informed consent approved by Institutional review board or Ethic committee
Exclusion Criteria:
* Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
* Serious co-morbid diseases
* Pregnancy or breast feeding
* Previous history of drug allergy to one of the drugs in the study regimen
* During this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01068392
Study Brief:
Protocol Section:
NCT01068392