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Clinical Trials in Canada / NCT06513962
Recruiting Phase 3

Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

NCT06513962 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-02-27
Last updated
2026-08-31

Condition(s) studied

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Best PracticeBiospecimen CollectionElectronic Health Record ReviewSurvey AdministrationTriptorelin Pamoate →

Best Practice: Receive standard chemotherapy

Biospecimen Collection: Undergo blood sample collection

Electronic Health Record Review: Ancillary studies

Survey Administration: Ancillary studies

Triptorelin Pamoate: Given IM

Study summary

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

Eligibility

Sex
FEMALE
Min age
—
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria: * \< 40 years of age at the time of enrollment * Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.) * Newly diagnosed with first cancer, exclusive of breast cancer. * Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma). * Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC). * Expected cumulative cyclophosphamide equivalent dose (CED): * For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group. * For patients ≥ 20 years of age and \< 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group. * For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group. Note that CED includes all administration routes: intravenous (IV), oral (PO), IM. * The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: * Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI). * Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged). * Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc. * Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions. * Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period. * Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment. * Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI). * Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential. * Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose). * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

Primary outcome measure(s)

Trial sites (206)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama Recruiting
University of Alabama at Birmingham Cancer Center Birmingham Alabama Recruiting
USA Health Strada Patient Care Center Mobile Alabama Recruiting
Phoenix Childrens Hospital Phoenix Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
CARTI Cancer Center Little Rock Arkansas Recruiting
City of Hope Comprehensive Cancer Center Duarte California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
Loma Linda University Medical Center Loma Linda California Recruiting
Mattel Children's Hospital UCLA Los Angeles California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
Children's Hospital of Orange County Orange California Recruiting
Sutter Medical Center Sacramento Sacramento California Recruiting
UC San Diego Medical Center - Hillcrest San Diego California Suspended
Rady Children's Hospital - San Diego San Diego California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado Recruiting
Connecticut Children's Medical Center Hartford Connecticut Recruiting
Beebe Medical Center Lewes Delaware Recruiting
Beebe South Coastal Health Campus Millville Delaware Recruiting
Helen F Graham Cancer Center Newark Delaware Recruiting
Medical Oncology Hematology Consultants PA Newark Delaware Recruiting
Christiana Care Health System-Christiana Hospital Newark Delaware Recruiting
Beebe Health Campus Rehoboth Beach Delaware Recruiting
Christiana Care Health System-Wilmington Hospital Wilmington Delaware Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida Recruiting
Nicklaus Children's Hospital Miami Florida Recruiting
Miami Cancer Institute Miami Florida Recruiting
AdventHealth Orlando Orlando Florida Recruiting
Nemours Children's Hospital Orlando Florida Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting

+ 166 more sites — see the full list on the official registry below.

More Children's Oncology Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06513962 on ClinicalTrials.gov ↗ ← All trials in Canada