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

Study ID
ALTE11C1

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Beverly Kleiber
214-456-6484
beverly.kleiber@childrens.com

Principal Investigator
Martha Stegner

Official Title

Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

Brief Overview


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.

Summary


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.

Participant Eligibility


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