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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT00505232
Eligibility Criteria:
Inclusion Criteria:
* All histologic MCL subtypes (WHO classification)
* Age between 18 and 70 years old
* Performance status 0 to 2 (ECOG)
* Cardiac ejection fraction \>50%
* Adequate organ (hepatic, cardiac and renal) and marrow function: Hb\> 10g/dl, neutrophil counts\> 1500/ µl, platelet\> 100000/ µl. Creatinine \< 2,5xULN, bilirubin, AST or ALT\<2,5xULN.
* For Y90-ibritumomab tiuxetan administration: Bone Marrow Infiltration by lymphoma cells \< than 25% ; platelet count \>100,000/µl and neutrophil counts \>1500/µl
* Informed consent should be obtained
Exclusion Criteria:
* Ann Arbor stages I or II without B symptoms or bulky disease (\>10 cm).
* Previous chemotherapy or radiotherapy treatment.
* Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or metabolic illness.
* Symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
* HIV, HBV or HCV positive serology.
* Limitation of the patient´s ability to comply with the treatment or follow-up protocol.
* Men and women with reproductive potential who are not using effective contraceptive methods during and at least 12 months after the end of the study
* Acute or chronic active infection.
* Known hypersensitivity to some of the drugs or other related compounds
* No informed consent obtained
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00505232
Study Brief:
Protocol Section:
NCT00505232