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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT00882206
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of lymphoblastic lymphoma or acute lymphoblastic leukemia with ≥ 5% blasts in the bone marrow (M2/M3) (with or without extramedullary disease) that meets 1 of the following criteria:
* Refractory disease/induction failure (failure to achieve initial remission after 2 lines of induction therapy)
* Relapsed disease (in first relapse or higher)
* Central nervous system (CNS)-positive disease allowed
* Karnofsky performance status (PS) 50-100% (for patients ≥ 16 years of age) OR Lansky PS 50-100% (for patients \< 16 years of age)
* Life expectancy ≥ 8 weeks
* Creatinine clearance ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
* 0.4 mg/dL (for patients 1 to 5 months of age)
* 0.5 mg/dL (for patients 6 to 11 months of age)
* 0.6 mg/dL (for patients 1 year of age)
* 0.8 mg/dL (for patients 2 to 5 years of age)
* 1.0 mg/dL (for patients 6 to 9 years of age)
* 1.2 mg/dL (for patients 10 to 12 years of age)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
* ALT \< 5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN for age
* LVEF ≥ 40% by ECHO/MUGA scan
* Shortening fraction \> 29% by ECHO/MUGA scan
* Able to swallow capsules
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after completion of study treatment
* No untreated positive blood cultures or progressive infections as assessed by radiographic studies
* No known allergy to any of the agents or their ingredients used in this study
* Patients with clinically significant prior allergies to pegaspargase may be treated with asparaginase-Erwinia, if available
* Patients who cannot receive asparaginase on this study (e.g., due to prior pancreatitis, stroke, or other toxicity) are eligible provided they meet all other inclusion/exclusion criteria
* Recovered from prior therapy (defined as CTCAE v3.0 toxicity ≤ grade 1)
* More than 3 weeks since prior chemotherapy for cancer other than hydroxyurea for patients with WBC \> 10,000/mm³
* At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)
* At least 1 month since prior biologic therapy, such as monoclonal antibodies
* At least 3 months since prior hematopoietic stem cell transplantation
Exclusion Criteria:
* Evidence of graft-versus-host disease
* Concurrent valproic acid
* Concurrent coumadin/warfarin other than a short course administered in a prophylactic setting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
60 Years
Study:
NCT00882206
Study Brief:
Protocol Section:
NCT00882206