Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor

PRIMARY OBJECTIVES:

I. To collect preliminary information to help design a study to look at longitudinal changes
in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine
kinase inhibitors (TKI) therapy.

SECONDARY OBJECTIVES:

I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to
undergo in vitro fertilization (IVF) for fertility preservation.

OUTLINE:

Patients undergo transvaginal ultrasound for antral follicles analysis and collection of
serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and
48 weeks.

Inclusion Criteria:

- Diagnosed with chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST),
non metastatic cancer where TKI is the first line agent

- Premenopausal (has had menses at any time in the preceding 12 consecutive months)

- Has not undergone a hysterectomy or bilateral oophorectomy

- Willing to use non-hormonal (ie: barrier method or abstinence) as form of
contraception during the one year of study

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy in the past

- Patients may not be receiving any other investigational agents

- Patients must not be pregnant or nursing

- Other medical conditions or treatments that affect hormonal levels (potentially
confounding interpretation of results)

- Patients with ongoing hormonal contraception or unwilling or unable to discontinue
will not eligible