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Clinical Trial COGALTE11C1


ALTE11C1 - Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma

Principal Investigator(s)

Debra Friedman


  • Protocol No. COGALTE11C1
  • Open Date: 08/21/2013
  • Staging: N/A
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: 1.1.1 Compare Anti Mullerian Hormone (AMH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) between patients at baseline and cross section of controls and again between patients at 12 months off therapy and cross section of controls. 1.1.2 Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.
  • Disease Sites: Pediatric Lymphoma
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01793233
  • Secondary Protocol No: ALTE11C1


None Provided.


Ages Eligible for Study:N/A to 29 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Patients must have had first menses >= 6 months prior to enrollment
• Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma
• Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year
• Patients with any performance status are eligible for enrollment
• Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues
• 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
Exclusion Criteria:
• Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible
• Patients who have a secondary malignancy are not eligible
• Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible
• Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible
• Patients who previously have had their uterus or ovary(ies) removed are not eligible
• Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible
• Patients who are pregnant or breast feeding are not eligible
• Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible