WithdrawnNot Applicable

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

Stopped: Lack of accrual

United States0Started 2016-03-01

Plain-language summary

This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy on ovarian reserve and fertility in patients with chronic myeloid leukemia or gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer

Timeframe: Baseline to up to 1 year

Trial details

NCT IDNCT02734823

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-14

View on ClinicalTrials.gov More Chronic Myelogenous Leukemia, BCR-ABL1 Positive trials