ALTE11C1, Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma

Study ID
STU 102013-076

Cancer Related

Healthy Volunteers

Study Sites

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

Beverly Kleiber

Principal Investigator
Martha Stegner, M.D.


eligible and consenting participants will be asked about their medical history, including information about their menstrual period. Study participation will include the collection of 5 blood samples over the course of the study to measure ovarian function. The blood draw at each study visit will be 15 ml (or about 1 tablespoon). The total amount of blood taken over the course of the study will be 75 ml (or about 5 tablespoons). all blood draws will be coordinated with regularly scheduled clinic visits/blood draws at the following time points:

Required Blood Draws:
1. at Diagnosis
2. at the beginning of the 3rd cycle of treatment
3. end of treatment
4. 6 Months after treatment
5. 12 months after treatment

in addition, participants will be asked about banking additional blood and leftover blood for future research.

at the beginning of this study, participants will be asked to complete a brief questionnaire about their background, past medical history, and reproductive history. This questionnaire should take about 10 minutes to complete. Participants will be asked to keep a diary with the start and stop dates of their menstrual period. Participants will also be asked to give researchers an update on their reproductive health, including information about their period and any medications that they are taking at different times throughout the study. Researchers will collect details about the type and amount of chemotherapy that each participant receives as treatment.

This is a prospective study designed to compare the measures of ovarian reserve in adolescent girls with newly diagnosed lymphoma receiving alkylator therapy at baseline and at 12 months off-therapy to those measures from a cross-section of healthy controls. only the case patients with lymphoma will be enrolled through this CoG group-wide study. The healthy controls will be recruited through a separate mechanism, outside of the CoG. Therefore the details of the protocol for enrollment of controls are not addressed in this iRB submission. iRB approval has been obtained at the local institution (Columbia university Medical Center) for the enrollment of controls.

Participant Eligibility

-- Age: Patients must be <= 21 years of age.
-- Gender: Gender must be female
-- Menstrual Status:Patients must have had first menses > 6 months prior to enrollment.
-- Diagnosis: 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 Treatment: Planned cancer treatment must include an alkylating agent: ie procarbazine, cyclophosphamide, ifosphamide. Planned cancer treatment must be less than one year.
-- Performance Level: Patients with any performance status are eligible for enrollment.
-- Concomitant Medications Restrictions: Patients may take oral contraceptives.