Introduction

This family protocol summary provides a general overview of the Children's Oncology Group (COG) study ALTE11C1. It tells who is eligible and gives basic information about the study goals. More details about the study are in the consent form. You can get this from your oncologist.

ALTE11C1 is a Cancer Control and Supportive Care (CCLSC) Study. CCLSC studies are performed to help learn how to best deal with, or prevent complications of cancer and cancer treatment. They may study traditional medical treatments, non-traditional medicines and treatments (called complementary or alternative treatments) and other approaches. CCLSC studies may focus on complications that affect the quality of life or on life expectancy, or they may involve measuring and evaluating behaviors of the child with cancer or their family members.

Participating in a clinical trial is voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find more information about clinical trials at www.childrensoncologygroup.org. You can discuss any questions with your treatment team.

Study Number

ALTE11C1

Official Title

Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma

Study Opening Date

ALTE11C1 opened on 6/17/2013. The ALTE11C1 committee hopes to enroll around 200 patients. It is expected that this study will remain open until approximately October 2016.

General Patient Eligibility

• Age: Female patients younger than 30 years of age
• Diagnosis:newly diagnosed lymphoma
• menstruating for at least 6 months prior to enrollment

Please consult your doctor to determine whether your child may participate in this study.

General Background and Study Goal

Cancer treatment, particularly some chemotherapy medicines used to treat lymphoma, can affect a female's ability to ever become pregnant. These medicines reduce the number of ovarian follicles where eggs develop. The number of follicles in a woman's body naturally declines with age, decreasing fertility and eventually leading to menopause. When menopause occurs, periods stop and having children is no longer possible. If follicles are damaged or destroyed by chemotherapy, menopause can occur at an earlier age than usual. This is called premature menopause. If this happens shortly after treatment has ended (within 5 years), it is called acute ovarian failure.

While many adolescent girls are exposed to the same lymphoma therapy, only some develop acute ovarian failure or premature menopause. The reasons why some do and some do not are largely unknown and unpredictable. There are interventions available that may preserve the ability to become pregnant in the future, such as embryo or egg freezing, but these interventions are time-consuming and expensive, and not guaranteed to be successful. It is hard for doctors to recommend these interventions when the actual risk of infertility is unknown.

This study investigates the effects of current adolescent lymphoma therapy on the ovaries. The study objective is to measure ovarian reserve (the number of eggs in ovaries). This is done by measuring blood markers, substances in the blood that represent ovarian reserve, at various times before therapy, during therapy and up to 12 months following the end of therapy.

These ovarian reserve markers are Anti Mullerian Hormone (AMH), Follicle Stimulating Hormone (FSH), and Estradiol (E2). Identifying which young women with lymphoma are at risk for ovarian failure will help doctors counsel future patients and their families about their infertility risk.

Summary of the Study

Patients enrolled in this study will be asked to complete a Patient Questionnaire and have blood drawn for ovarian reserve markers before treatment begins. Patients or parents will also be given a menstrual diary to document menstrual periods over the course of study participation.

Blood will be drawn, and patients will be asked to fill out a menstrual period and medication report at four additional time points:

• 3rd cycle of chemotherapy
• end of treatment
• 6 months after treatment
• 12 months after treatment

Special Considerations

• All blood samples will be drawn during regularly scheduled visits.
• Since we do not know the significance of the individual test results, neither you, nor your physician will be informed of the test results.
• The results of the study will not be placed in your medical chart.
• Patients will be asked to participate in an optional study that asks for an additional blood sample for future research, including looking at how DNA (genetic material in your body) responds to the cancer treatment.
  •  Patients may still participate in the study without this sample.

Risks and Side Effects

All risks and side effects will be explained by your study team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the study.

The study consent form has more details about possible risks and side effects of this study.

Contact Information

Your child's oncologist and nurses are the best sources for further information.

Study Chair

Jennifer M. Levine, MD, MSW

Columbia University Medical Center

Family Protocol Summary Review/Approvals