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A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population (FERTILEA)

Primary Purpose

Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI pelvic
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease

Exclusion Criteria:

  • Female with uneligible MRI exam conditions

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

irradiation regimen before 9

busulfan regimen before 9

irradiation regimen after 9

busulfan regimen after 9

Arm Description

Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed

Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed

Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed

Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed

Outcomes

Primary Outcome Measures

Uterin Anatomy
Pelvic echography: Quantitative estimation of the residual ovarian reserve with the count of antral follicles and the thickness of the endometrium and ovarian volume Pelvic IRM: the maximum size of functional endometrium in the proliferative phase

Secondary Outcome Measures

Full Information

First Posted
March 22, 2018
Last Updated
July 11, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03583294
Brief Title
A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population
Acronym
FERTILEA
Official Title
A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The French L.E.A. (Leucémie Enfant et Adolescent) program was implemented to prospectively evaluate the long-term health status, quality of life and socio-economic status of childhood acute leukemia (CAL) survivors enrolled in French treatment programs from 1980 to present, in 15 cancer centers. Eligible patients for the study are adult women (≥18 years) from L.E.A. cohort. Project has been approved by the Scientific Advisory Board and the Steering Committee of LEA Cohort. MRI uterus anatomy, follicular ovarian reserve and reproductive function will be assess in 212 adult women who received a hematopoietic stem cell transplantation (HSCT) for CAL. The investigator's objective is to correlate uterus and ovarian function to the conditioning regimen received before HSCT (total body irradiation (TBI) or busulfan - based conditioning) and the pubertal status at the HSCT (before or after puberty).Inclusion period is planned for 2 years. Four patient groups will be compared: Group 1: HSCT before nine years and after conditioning regimen with TBI (12 Gy) Group 2: HSCT before nine years and after a busulfan-based conditioning regimen Group 3: HSCT after nine years and after conditioning regimen with TBI (12 Gy) Group 4: HSCT after nine years and after a busulfan-based conditioning regimen Information will be collected during specific medical visit in one of the investigatory centers. Pelvic MRI and hormonal blood tests will be performed and a medical consultation with a physician specialized in reproductive medicine and oncofertility will be proposed to eligible patients. Data assessed for each women are the following: Disease type, age and pubertal status at HSCT, age at evaluation, therapy lines before and after HSCT, conditioning regimen, relapse after HSCT if applicable. Cumulative doses of cyclophosphamide, melphalan, busulfan and radiation will be collected from the LEA database. Gynecological characteristics: spontaneous or induced puberty, spontaneous menstrual cycles or Hormone Substitutive treatment (HRT) or amenorrhea without HRT; gestity parity (if pregnancy: spontaneous, after Assisted Reproductive Technologies?), history of ovarian cryopreservation, was information given (and at what age?) about risk of premature ovarian failure and about the gyneco-obstetrical impact of conditioning regimen for HSCT? Ovarian follicular reserve: FSH, LH, estradiol, Anti-Müllerian Hormon (AMH) at the day 2-3 of the cycle or whenever if amenorrhea. Ovarian volume and antral Follicle Count will be performed with pelvic sonography. Uterine anatomy by MRI, at the end of follicular phase or after estrogen therapy, in order to measure proliferative endometrium. Anatomical parameters will be compare to normal measurements of uterus: uterine volume, myometrial, endometrial and junctionnal zone thickness, cervical length, apparent diffusion coefficient values. Reproductive function: spontaneous pregnancy rate or after ART (IVF, oocyte donation), term and mode of delivery, health of the child.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
irradiation regimen before 9
Arm Type
Experimental
Arm Description
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed
Arm Title
busulfan regimen before 9
Arm Type
Experimental
Arm Description
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed
Arm Title
irradiation regimen after 9
Arm Type
Experimental
Arm Description
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed
Arm Title
busulfan regimen after 9
Arm Type
Experimental
Arm Description
Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed
Intervention Type
Other
Intervention Name(s)
MRI pelvic
Intervention Description
Pelvic MRI
Primary Outcome Measure Information:
Title
Uterin Anatomy
Description
Pelvic echography: Quantitative estimation of the residual ovarian reserve with the count of antral follicles and the thickness of the endometrium and ovarian volume Pelvic IRM: the maximum size of functional endometrium in the proliferative phase
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease Exclusion Criteria: Female with uneligible MRI exam conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blandine COURBIERE, MD/PhD
Phone
+33 491383675
Email
blandine.courbiere@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO PRADALIE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blandine Courbiere, MD/PhD
Email
blandine.courdbiere@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population

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