Umbrella Long-Term Follow-Up Protocol

Umbrella Long-Term Follow-Up Protocol

November 22, 2017

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica

    Trial Phone: 321.841.3837

  • IRB No: ALTE05N1

    Principal Investigator: Vincent F. Giusti, MD

    Sub Investigators: AguilarBonilla, Ana MD; Eslin, Don MD; Gray, Rachel PA-C; Kelly, Susan MD; Martin, Rebecca, ARNP; Pope, Michele ARNP; Smith, Amy MD; Story, Allison ARNP; Sullivan, Kelly ARNP; Sutphin, Robert MD; Wieber, Laura ARNP; Levy, Alejandro MD

    Age Group: Pediatric

    Secondary Protocol No: ALTE05N1

    Treatment: Non-Treatment

    Applicable Disease Sites: All Oncology Sites

    Therapies Involved: Other: survey administration Procedure: assessment of therapy complications Procedure: long-term screening Procedure: study of high risk factors

    ClinicalTrials.gov ID: NCT00736749

  • Objective

    Developing a way to track patients enrolled in studies will help doctors gather long-term follow-up information and may help the study of cancer.

  • Key Eligibility

    Eligibility

    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No
    Sampling Method: Non-Probability Sample

    Study Population

    Patients with Hodgkin lymphoma enrolled on CCG-5942, POG-9425, POG-9426, COG-AHOD0031; patients with brain tumors enrolled on CCG-A9961; patients with acute lymphoblastic leukemia enrolled on POG-9404; patients with rhabdomyosarcoma

    Criteria


    Inclusion Criteria:
    •  The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy and is nearing completion of or has recently completed protocol treatment (within the past 180 days)*; or the patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1
    ◦Hodgkin lymphoma
    ◾CCG-5942
    ◾POG-9425
    ◾POG-9426
    ◾COG-AHOD0031

    ◦Brain tumor
    ◾CCG-A9961

    ◦Acute lymphoblastic leukemia
    ◾POG-9404

    ◦Rhabdomyosarcoma
    ◾IRS-III
    ◾IRS-IV

    ◦Note: For purposes of enrollment onto this study, completion of treatment is defined as the date protocol therapy was terminated as reported (or will be reported) on this patient's last "Reporting Period Worksheet/CRF" for their frontline therapeutic protocol; patients become eligible as they approach this date, and remain eligible for 180 days following the date that protocol therapy was terminated; early termination of protocol therapy per the decision of the patient, family and/or investigator does NOT preclude enrollment on this study
    ◦Note: For purposes of eligibility for ALTE05N1, "early termination of protocol therapy" means that the patient has finished protocol therapy and will not receive further treatment; patients whose therapy is terminated early due to toxicity or who opt out of an end-of-therapy randomization (e.g., randomization to continue with an experimental agent vs. no further treatment) are eligible because they will not be receiving further therapy; however, a patient who is removed from protocol therapy or opts to discontinue protocol participation early in the course of treatment (e.g., following Induction) is not eligible

    •  The patient must reside in the U.S. on the date of enrollment to ALTE05N1
    •  All patients and/or their parents or legal guardians must sign a written informed consent
    •  All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met