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 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT01796405
Eligibility Criteria:
Inclusion Criteria:
* Have failed first line treatment with prednisone and vinblastine
* Clinical evidence of involvement of hematopoietic system, liver or spleen
* Have failed salvage treatment with cladribine/cytarabine or are not considered to be eligible for such treatment
* Willing to use effective contraception during study and for six months after study treatment
* Adequate marrow and organ function
Exclusion Criteria:
* Pregnant or breastfeeding
* Have received chemotherapy or radiotherapy within 2 weeks of study entry
* Have not recovered from adverse events due to previously administered agents
* Receiving other study agents
* Taking drugs with known renal toxicity
* Use of alternative medicine during study treatment
* Uncontrolled intercurrent illness
* History of a different malignancy except if disease-free for at least five years or within five years for cervical cancer in situ and basal and squamous cell carcinoma of the skin
* Known to be HIV positive on antiretroviral therapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01796405
Study Brief:
Protocol Section:
NCT01796405