Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

Children's Oncology Group

Status: Active, not recruiting

Conditions: Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma; Lymphoma; Diffuse Large B-Cell Lymphoma; Burkitt Lymphoma

Treatments: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01793233

ALTE11C1 (Other Identifier)

COG-ALTE11C1 (Other Identifier)

NCI-2013-00069 (Registry Identifier)

UG1CA189955 (U.S. NIH Grant/Contract)

U10CA095861 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

Full description

PRIMARY OBJECTIVES:

I. 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.

II. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

III. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.

IV. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.

SECONDARY OBJECTIVES:

I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.

OUTLINE:

Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collection at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.

Enrollment: 203 patients

Sex: Female

Ages: Under 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

203 participants in 1 patient group

Ancillary-Correlative (menstrual diary, biomarker analysis)

Description:

Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collections at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.

Treatment:

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis