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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00801918
Eligibility Criteria:
Inclusion Criteria:
* Age: Patients must be ≥ 2.00 year and ≤ 24.99 years of age at the time of study entry.
* Diagnosis:
Patients must have previous histologic verification of anaplastic large cell lymphoma (ALCL). Patients must be in first, second or third relapse or initial induction failure.
\- Disease Status: Patients must have measurable radiographic disease.
\- Performance Level: Karnofsky \> 60% for patients \> 16 years of age and Lansky \> 60 for patients \<16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
\- Prior Therapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Patients who are post-allogeneic transplant should be off immunosuppressive agents prior to starting therapy. Steroid doses should also be stable or decreasing for at least 1 week prior to starting therapy.
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea).
Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. These patients must be discussed with the Study Chair on a case-by-case basis.
XRT: \> 2 wks for local palliative XRT (small port); \> 2 months must have elapsed if prior TBI, craniospinal XRT or if \> 50% radiation of pelvis; \> 6 wks must have elapsed if other substantial BM radiation.
Stem Cell Transplant or Rescue: No evidence of active graft vs. host disease and \> 2 months must have elapsed since SCT.
Patients may not have received prior therapy with Denileukin Diftitox
\- Organ Function Requirements
Adequate Bone Marrow Function Defined As:
1. For patients without bone marrow involvement:
* Peripheral absolute neutrophil count (ANC) \> 1,000
* Platelet count \> 100,000 (transfusion independent)
* Hemoglobin \> 8.0 gm (RBC transfusion independent)
2. For patients with bone marrow involvement:
* Peripheral absolute neutrophil count (ANC) \> 1,0
* Platelet count \> 20,000 (may receive platelet transfusions)
* Hemoglobin \> 8.0 (may receive RBC transfusions)
Adequate Renal Function Defined As:
Creatinine clearance or radioisotope GFR 70mL/min/1.73m2
OR
A serum/plasma creatinine GFR calculation using the Schwartz formula (Schwartz et al. J. Peds, 106:522, 1985)
Estimated Creatinine Clearance (in mL/min/1.73 m2) = (k)(L)/Pcr
Where L = child's length in cm Pcr = plasma (or serum) creatinine (in mg/dL)
k Values = 0.33 low birth weight infant 0.45 term infant 0.55 child 0.55 adolescent female 0.70 adolescent male
Adequate Liver Function Defined As:
* Bilirubin (sum of conjugated + unconjugated) \< 1.5 x upper limit of normal (ULN) for age, and
* SGPT (ALT) \< 3 x upper limit of normal (ULN) for age
* Serum albumin \> 2 g/dL.
Exclusion Criteria:
* Patients must not be currently receiving another investigational drug.
* Patients must not be currently receiving other anti-cancer agents.
* Patients must have a negative pregnancy test and Nursing mothers must agree not to breast-feed.
* Patients who have a documented uncontrolled infection requiring IV antibiotics
* Patients with CNS disease are not eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
24 Years
Study:
NCT00801918
Study Brief:
Protocol Section:
NCT00801918