Clinical trial NCT02734823: Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor
Official title: Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Gastrointestinal Stromal Tumor
Premenopausal
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer
timeFrame: Baseline to up to 1 year
Secondary outcomes:
measure: Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Irene Woo
role: PRINCIPAL_INVESTIGATOR
References: