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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT00003620
Eligibility Criteria:
Inclusion Criteria:
* Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or IV) refractory B-cell chronic lymphocytic leukemia
* Intermediate risk group must have evidence of active disease as shown by at least one of the following:
* Massive or progressive splenomegaly and/or lymphadenopathy
* Weight loss of greater than 10% in the last 6 months
* CALGB grade 2-4 fatigue
* Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection
* Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months
* Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine
* Lymphocytosis greater than 5000/mm3 at some time during disease
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab)
* At least 1, but no more than 3, prior chemotherapy regimens
* At least 1 prior chemotherapy regimen comprising fludarabine
* No other concurrent chemotherapy
* No concurrent chronic use of oral corticosteroids
* No concurrent hormone therapy except for non-disease related conditions
* No concurrent dexamethasone or other corticosteroid-based antiemetics
* No concurrent palliative radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003620
Study Brief:
Protocol Section:
NCT00003620