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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT01162551
Eligibility Criteria:
Inclusion Criteria:
* Patients \</= 25 years of age, at time of enrollment, with second or greater relapse of ALL or NHL. For ALL must have histologic diagnosis with \>10% blasts in the marrow and for lymphoblastic lymphoma or peripheral T-cell lymphoma must have radiologic or physical evidence of recurrence.
* Lansky \> 50% or Karnofsky \> 50%
* Negative Pregnancy Test
* Creatinine clearance or radioisotope GFR \> 70ml/min/m2 OR serum creatinine based on age /gender
* Pulse ox \>94%
* Total Bilirubin \<1.5 x normal for age
* ALT \< 5 x normal for age
* Albumin \> 2g/dL
* Shortening fraction by echo \> 28% OR ejection fraction \> 50% by gated radionuclide study
Exclusion Criteria:
* Patient has known allergies to sirolimus,FK-506 or mTOR inhibitors
* Patient is taking other investigational anti-neoplastic drugs
* Patient received no myelosuppressive chemo within 14 days
* \< 14 days have elapsed since local palliative XRT (small port) \< 28 days since prior craniospinal XRT or 50% radiation of pelvis \<28 days if other substantial BM radiation
* Hematopoietic growth factors within 7 days of entry (except erythropoietin.)
* Patient has taken any biologic agents within 14 days
* Post BMT/SCT - evidence of active GVHD, at least \> 3 months must have elapsed
* Patient has uncontrolled infection (if patients with fungal disease, stable for \< 14 days and patients with bacteremia without negative blood culture
* Existing non-hematologic toxicities \> grade 2
Use of steroids or hydroxyurea is permitted upto 14 days prior to entry.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
25 Years
Study:
NCT01162551
Study Brief:
Protocol Section:
NCT01162551