Clinical trial • Phase III • Oncology|Haematology
triptorelin for Breast cancer|Acute leukemia|Hodgkin lymphoma|Non-Hodgkin lymphoma|Osteosarcoma|Soft tissue sarcoma|Ewing sarcoma
Phase III trial of triptorelin for Breast cancer|Acute leukemia|Hodgkin lymphoma|Non-Hodgkin lymphoma|Osteosarcoma|Soft tissue sarcoma|Ewing sarcoma.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Breast cancer|Acute leukemia|Hodgkin lymphoma|Non-Hodgkin lymphoma|Osteosarcoma|Soft tissue sarcoma|Ewing sarcoma
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Other
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 25-10-2024
Trial design
Randomised, placebo: 0.9% sodium chloride solution (placebo syringes need to be covered with aluminium foil by the unblinded research nurse to maintain the study blind). test/active: pamorelin (triptorelin) 3.75 mg prolonged-release suspension for injection, intramuscular; pamorelin (triptorelin) 11.25 mg prolonged-release suspension for injection, intramuscular. schedule not specified in the available data.-controlled Phase III trial across 21 sites in Sweden.
- Randomised
- Yes
- Comparator
- Placebo: 0.9% Sodium Chloride solution (placebo syringes need to be covered with aluminium foil by the unblinded research nurse to maintain the study blind). Test/active: Pamorelin (triptorelin) 3.75 mg prolonged-release suspension for injection, intramuscular; Pamorelin (triptorelin) 11.25 mg prolonged-release suspension for injection, intramuscular. Schedule not specified in the available data.
- Target Sample Size
- 500
Eligibility
Recruits 500 paediatric patients.
- Pregnancy Exclusion
- Pregnancy or breastfeeding at time of start of chemotherapy
- Vulnerable Population
- Vulnerable population selected. Trial includes adolescents aged 14-17. 'Signed informed consent' is required. Subject information and informed consent form documents present for adults and for 14-17 year olds ('L1_SIS and ICF_adults_v3_0_20220516' and 'L1_SIS and ICF_14-17 yr_v3_0_20220516').
Inclusion criteria
- {"criterion_text":"- Signed informed consent\n- Age 14-42 years at cancer diagnosis\n- Female subjects with breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for disease-specific chemotherapy\n- Confirmed menarche\n- ECOG performance status 0-1\n- Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders"}
Exclusion criteria
- {"criterion_text":"- Ongoing treatment with GnRHa at baseline\n- Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data\n- Previous or planned bilateral oophorectomy\n- Pregnancy or breastfeeding at time of start of chemotherapy\n- Other malignancy diagnosed within the last five years\n- Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia\n- Known osteoporosis\n- Known refractory thrombocytopenia in subjects with acute leukemias\n- Known or suspected allergy against triptorelin\n- Direct radiation of the gonads previous or planned (total body irradiation allowed)\n- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The difference in recovery of AMH levels at follow-up 12 months after EoT, relative to AMH levels at EoT, as compared between the GnRHa group and the placebo group in women with breast cancer.","definition_or_measurement_approach":"Determination of Anti-Müllerian Hormone (AMH) at 12 months after end of gonadotoxic treatment (EoT) compared to AMH at EoT; comparison between GnRHa and placebo groups."}
Secondary endpoints
- {"endpoint_text":"- The difference in recovery of AMH levels at follow-up 12 months after EoT, relative to AMH levels at EoT, between the GnRHa group and the placebo group in women with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Determination of AMH at 12 months after EoT compared to AMH at EoT; comparison between GnRHa and placebo groups in acute leukemias, lymphomas and sarcomas."}
- {"endpoint_text":"- Comparison of AFC measured by ultrasound at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Antral follicle count (AFC) measured by ultrasound at EoT, 6 and 12 months after EoT and then annually years 2-5; comparison between groups."}
- {"endpoint_text":"- The difference in recovery of AMH levels at 6 months, and follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Longitudinal determination of AMH at 6 months and annually years 2-5 after EoT; comparison between groups."}
- {"endpoint_text":"- Comparison of FSH, inhibin and estradiol performed at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Measurement of FSH, inhibin and estradiol at specified timepoints (EoT, 6, 12 months, years 2-5); comparison between groups."}
- {"endpoint_text":"- Comparison of blood flow to the ovarian artery (right and left Doppler flow PI, RI) at baseline, EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Doppler ultrasound measurement of ovarian artery blood flow (PI, RI) at baseline, EoT, 6, 12 months and annually years 2-5; comparison between groups."}
- {"endpoint_text":"- Comparison of the proportion that develop amenorrhea (no menstruations) at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group:in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Assessment of amenorrhea (absence of menstruation) at EoT, 6, 12 months and annually years 2-5; proportion comparison between groups."}
- {"endpoint_text":"- Investigation of the impact of BMI, use of contraceptives and endocrine adjuvant therapy in changes of ovarian reserve with or without GnRHa by longitudinal observation of AMH levels, FSH, inhibin and estradiol at standardized timepoints","definition_or_measurement_approach":"Longitudinal observation of AMH, FSH, inhibin and estradiol at standardized timepoints to evaluate impact of BMI, contraceptive use and adjuvant endocrine therapy."}
- {"endpoint_text":"- Comparison of of pregnancy wish, pregnancy attempts and pregnancy outcomes at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Capture of pregnancy wish, attempts and outcomes at EoT, 6, 12 months and annually years 2-5; comparison between groups."}
- {"endpoint_text":"- Comparison of health-related QoL, sexuality and reproductive health examined at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Assessment of health-related quality of life, sexuality and reproductive health at specified timepoints; comparison between groups."}
- {"endpoint_text":"- Comparison of bone mineral density at baseline, EoT and 12 months after EoT and follow-up year 5, between the GnRHa group and the placebo group: in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Measurement of bone mineral density at baseline, EoT, 12 months and year 5; comparison between groups."}
- {"endpoint_text":"- Investigation of recurrence rate, overall survival and disease-free survival at 12 months after EoT and follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group:in women with breast cancer and in woman with acute leukemias, lymphomas and sarcomas.","definition_or_measurement_approach":"Assessment of recurrence rate, overall survival and disease-free survival at 12 months and annually years 2-5; comparison between groups."}
Recruitment
- Planned Sample Size
- 500
- Recruitment Window Months
- 96
- Consent Approach
- Signed informed consent required. Subject information and informed consent forms available for adults and for 14-17 year olds (documents: 'L1_SIS and ICF_adults_v3_0_20220516' and 'L1_SIS and ICF_14-17 yr_v3_0_20220516'). No languages or additional consent/assent details provided in the available data.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 500
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 13
- Number Of Sites
- 21
- Number Of Participants
- 500
Sites
- Site Name
- Region Oerebro Laen
- Department Name
- Universitetssjukhuset Örebro, Oncology
- Contact Person Name
- Antonios Valachis
- Contact Person Email
- antonios.valachis@oru.se
- Site Name
- Soedersjukhuset AB
- Department Name
- Oncology
- Contact Person Name
- Anna Von Wachenfeldt Väppling
- Contact Person Email
- anna.vonwachenfeldt-vappling@regionstockholm.se
- Site Name
- Karolinska University Hospital
- Department Name
- Breast, Endocrine Tumors and Sarcoma
- Contact Person Name
- Tobias Lekberg
- Contact Person Email
- tobias.lekberg@regionstockholm.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Oncology
- Contact Person Name
- Barbro Linderholm
- Contact Person Email
- barbro.linderholm@oncology.gu.se
- Site Name
- Capio S:t Goerans Sjukhus AB
- Department Name
- Oncology
- Contact Person Name
- Eneida Lindfors
- Contact Person Email
- eneida.lindfors@capiostgoran.se
- Site Name
- Karolinska University Hospital
- Department Name
- Gynecology and Reproductive Medicine
- Contact Person Name
- Kenny Rodriguez-Wallberg
- Contact Person Email
- kenny.rodriguez-wallberg@regionstockholm.se
- Site Name
- Uppsala University Hospital
- Department Name
- Center for Pediatric Oncology, Akademiska Sjukhuset
- Contact Person Name
- Per Frisk
- Contact Person Email
- per.frisk@akademiska.se
- Site Name
- Region Oerebro Laen
- Department Name
- Hematology
- Contact Person Name
- Bertil Uggla
- Contact Person Email
- bertil.uggla@regionorebrolan.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Pediatric Oncology
- Contact Person Name
- Helena Mörse
- Contact Person Email
- helena.morse@med.lu.se
- Site Name
- Uppsala University Hospital
- Department Name
- Reproduction Center
- Contact Person Name
- Stavros Illiadis
- Contact Person Email
- stavros.illiadis@akademiska.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Reproduction RMC
- Contact Person Name
- Margareta Kitlinski
- Contact Person Email
- margareta.kitlinski@skane.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Women´s clinic SU East
- Contact Person Name
- Randa Akouri
- Contact Person Email
- randa.akouri@gu.se
- Site Name
- Region Vaesterbotten
- Department Name
- Norrlands universitetssjukhus, Daniel Naezéns väg, Oncology
- Contact Person Name
- Anne Andersson
- Contact Person Email
- anne.andersson@umu.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Hematology and Coagulation
- Contact Person Name
- Lovisa Vennström
- Contact Person Email
- lovisa.vennstrom@vgregion.se
- Site Name
- Soedersjukhuset AB
- Department Name
- Internal Medicine, Hematology
- Contact Person Name
- Mousa Majd
- Contact Person Email
- mousa.majd@regionstockholm.se
- Site Name
- Karolinska University Hospital
- Department Name
- Hematology
- Contact Person Name
- Sara Harrysson
- Contact Person Email
- sara.harrysson@regionstockholm.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematology
- Contact Person Name
- Niklas Loman
- Contact Person Email
- niklas.loman@med.lu.se
- Site Name
- Karolinska University Hospital
- Department Name
- High Specialized Pediatric Medicine
- Contact Person Name
- Johan Malmros
- Contact Person Email
- johan.malmros@regionstockholm.se
- Site Name
- Capio S:t Goerans Sjukhus AB
- Department Name
- Hematology
- Contact Person Name
- Barbro Kedinge
- Contact Person Email
- barbro.kedinge@capiostgoran.se
- Site Name
- Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
- Department Name
- Queen Silvia Hospital for Children and Youth Center for Pediatric Cancer
- Contact Person Name
- Karin Mellgren
- Contact Person Email
- karin.mellgren@vg.region.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Oncology
- Contact Person Name
- Mats Jerkerman
- Contact Person Email
- mats.jerkerman@med.lu.se
Sponsor
Primary sponsor
- Full Name
- Karolinska University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- 0.9% Sodium Chloride solution containing 9 mg/ml Sodium Chloride in water for injection. Placebo syringes need to be covered with aluminium foil by the unblinded research nurse to maintain the study blind.
- Modality
- Other
- Investigational Product Name
- Pamorelin 3,75 mg pulver och vätska till injektionsvätska, depotsuspension
- Active Substance
- triptorelin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAMUSCULAR USE
- Route
- Intramuscular
- Authorisation Status
- Authorised
- Starting Dose
- 3.75 mg
- Dose Levels
- 3.75 mg
- Maximum Dose
- 3.75 mg
- Investigational Product Name
- Pamorelin 11,25 mg pulver och vätska till injektionsvätska, depotsuspension.
- Active Substance
- triptorelin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAMUSCULAR USE
- Route
- Intramuscular
- Authorisation Status
- Authorised
- Starting Dose
- 11.25 mg
- Dose Levels
- 11.25 mg
- Maximum Dose
- 11.25 mg
- Combination Treatment
- Yes
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