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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT00566332
Eligibility Criteria:
Inclusion Criteria:
Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia) or Lymphoplasmacytic lymphoma or Splenic Marginal Zone Lymphoma, needing a treatment
* Life expectancy \> 6 months
* Creatinine \< 200 µmol/l
* SGPT and SGOT \< 2x ULN
* A negative direct Coombs test
* Written informed consent
Exclusion Criteria:
* Past chemotherapy/radiotherapy/immunotherapy prior to the study for Waldenström macroglobulinemia
* Previous malignancy less than 5 years ago except carcinoma in situ of the cervix and non-melanoma skin cancer
* Positive HIV serology
* Active Hepatitis B or C
* Lactation/pregnancy
* Impossible good compliance with the study protocol
* Active infection not controlled
* Psychological condition hampering understanding of the study
* Transformation into large B cell lymphoma
* Peripheral neuropathy \> grade II
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00566332
Study Brief:
Protocol Section:
NCT00566332