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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT01026220
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:
* Classical disease
* Nodular lymphocyte-predominant disease
* Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:
* Unexplained weight loss \> 10% within the past 6 months
* Unexplained recurrent fever \> 38°C within the past month
* Recurrent drenching night sweats within the past month
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
* 0.4 mg/dL (1 to 5 months)
* 0.5 mg/dL (6 to 11 months)
* 0.6 mg/dL (12 to 23 months)
* 0.8 mg/dL (2 to 5 years)
* 1 mg/dL (6 to 9 years)
* 1.2 mg/dL (10 to 12 years)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
* AST or ALT \< 2.5 times ULN for age
* Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to large mediastinal mass from HL)
* FEV\_1/FVC \> 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)
* For children who are unable to cooperate for PFTs, the criteria are:
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 92% on room air
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pathologic prolongation of QTc interval (\> 450 milliseconds) on 12-lead ECG
* No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy
* At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan
* No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)
* Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed
* No concurrent pegfilgrastim
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT01026220
Study Brief:
Protocol Section:
NCT01026220