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NCT Number: NCT04580576

Gender Differences in Pediatric Hematopoietic Stem Cell Transplantation (HSCT)

Gender medicine considers the way in which gender, male or female, affects the development and impact of diseases and the response to therapies. It can be said that it is a new transversal dimension of medicine, which evaluates the gender differences in the physiology, pathophysiology and clinic of many diseases and thus sets itself the goal of reaching optimal therapeutic decisions both in men and women based on proven scientific evidence.

Although knowledge of gender medicine has increased significantly in recent years, a gender approach has not been much developed in pediatrics. In the field of bone marrow transplants, hematopoietic stem cell transplantation is known to be the most effective consolidation therapy in some high-risk hematology malignancies such as acute lymphoblastic leukemia and acute myeloid leukemia, and represents one of the potential treatment for patients suffering from solid tumors and genetic hematological, metabolic diseases and primary immunodeficiencies. Huge progress has been made in high resolution donor typing, choice of conditioning regimens, manipulation of hematopoietic stem cells (HSC) and prevention of serious infections in recent years, which have significantly improved the survival rate of patients undergoing to this procedure.

International literature regarding the response and outcomes from hematopoietic cell transplantation in a gender perspective is completely absent, for these reasons this pilot study was born from the need to understand from a broader perspective and in order to better understand how the gender may or not influence the outcome of transplantation in pediatric patients.

This retrospective analysis of the data will concern all patients who underwent allogeneic or autologous bone marrow transplant. The data will be collected from clinical records and from Regional electronic databases. All data will be collected anonymously and an identification code will be assigned to each case.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Behavior Coitus Sexual Behavior

Age range

4 month–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 4 months and 17 years
  • Diagnosis of oncohaematological disease subjected to hematopoietic stem cell transplantation
  • Allogeneic or autologous bone marrow transplantation from January 2000 to October 2018
  • Consent acquired for the processing of data for research purposes

Treatment and study plan

Hematopoietic Stem Cell Transplantation

Procedure

Allogeneic or autologous bone marrow transplant

Primary outcomes

  1. Gender-related difference in overall 12-month toxicity

    Time frame: 12 months after transplant

    Differences in toxicity (hepatic, renal, pulmonary, gastrointestinal) in males and females recipients

Secondary outcomes

  1. Gender difference in overall survival (OS)

    Time frame: 12 months after transplant

    Overall survival comparison from males and females recipients

  2. Gender difference in post-transplant primary disease recurrence

    Time frame: 12 months after transplant

    Incidence of post-transplant leukemic relapse in males and females recipients

  3. Gender difference in the frequency of transplant-related toxicity at 12 months

    Time frame: 12 months after transplant

    Frequency of post-transplant liver, kidney, pulmonary, gastrointestinal, endocrine, cardiac toxicity

  4. Gender difference in infectious complications

    Time frame: 12 months after transplant

    Number of episodes of sepsis / fungal infections / viral reactivations after HSCT

  5. Gender difference in the frequency of adverse events due to pre-transplant conditioning regimen

    Time frame: 12 months after transplant

    Number of chemo- radiotherapy-related adverse events. Toxicity was graded according to National Cancer Institute (NCI) common toxicity criteria

  6. Gender difference in severity of adverse events due to pre-transplant conditioning regimen

    Time frame: 12 months after transplant

    Severity of chemo- radiotherapy-related adverse events. Toxicity wil be graded according to National Cancer Institute (NCI) common toxicity criteria

  7. Gender difference in timing of hematological engraftment

    Time frame: 12 months after transplant

    Engraftment defined as the engraftment of polymorphonuclear neutrophils (PMN) on the first day of 3 consecutive days with PMN number greater than 500 / ml3 and engraftment of platelets defined as number of platelets> 20,000 / ml3 in the absence of platelet transfusion in the previous 5 days.

  8. Gender difference in frequency of primary graft failure

    Time frame: 12 months after transplant

    Engraftment defined as the engraftment of polymorphonuclear neutrophils (PMN) on the first day of 3 consecutive days with PMN number greater than 500 / ml3 and engraftment of platelets defined as number of platelets> 20,000 / ml3 in the absence of platelet transfusion in the previous 5 days.

    Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse.

  9. Gender difference in frequency of secondary graft failure

    Time frame: 12 months after transplant

    Engraftment defined as the engraftment of polymorphonuclear neutrophils (PMN) on the first day of 3 consecutive days with PMN number greater than 500 / ml3 and engraftment of platelets defined as number of platelets> 20,000 / ml3 in the absence of platelet transfusion in the previous 5 days.

    Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Pilot Study on Gender Differences in Hematopoietic Cell Transplantation Outcomes in the Pediatric Population

Important dates

Study start
2000
Primary completion
2018
Study completion
2019
First posted
Oct 8, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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