Archive | Study Spotlight RSS for this section

Paediatric pulmonary thromboembolism (PPT). New study launched by The Canadian Paediatric Surveillance Program (CPSP)

The aim of this study is to document the minimum incidence of PPT, identify risk factors, and describe the diagnostic modalities as well as the therapeutic regimens used for treatment.

Find the protocol, case definition and questionnaire here: https://www.cpsp.cps.ca/surveillance/study-etude/paediatric-pulmonary-thromboembolism

Principal Investigators

  • Kristina R. Krmpotic, MD, MSc, FRCPC, Assistant Professor, Department of Critical Care Medicine, Dalhousie University and Department of Paediatric Intensive Care, IWK Health Centre
  • Paul C. Moorehead, MD, MS, MSc, FRCPC, Memorial University and Janeway Children’s Health and Rehabilitation, Paediatric Hematology/Oncology,

Primary objective

Document the minimum national incidence of pulmonary thromboembolism in children (age < 16 years), by age, gender, and province/territory of residence

Secondary objectives

  1. Describe the clinical presentation of pulmonary thromboembolism in children.
  2. Identify risk factors associated with pulmonary thromboembolism in children.
  3. Describe the diagnostic modalities used to identify pulmonary thromboembolism in children and the therapeutic regimens used for treatment
  4. Determine short -term outcomes of pulmonary thromboembolism in children, including complications of treatment.

Duration

January 2020 to December 2021

STUDY SPOTLIGHT: Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement (COG AALL15P1)

This pilot trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement.

  • Official Title: A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement
  • NOL Date: Canadian NOL 05-May-2017
  • Cooperative Group: Children’s Oncology Group
  • NCT02828358, COG  Protocol AALL15P1
  • For more information see: https://clinicaltrials.gov/ct2/show/NCT02828358

STUDY SPOTLIGHT: Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia

This multi-center open label clinical trial aims to identify predictors of low antibody titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6 months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and 13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2 months later. The results will support the development of clinical practice guidelines for this population.

Official Title: Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study
Cooperative Group: Canadian Immunization Research Network (CIRN)
Study ID: NCT02447718, CIRN SI02
For more information see, https://clinicaltrials.gov/ct2/show/NCT02447718 and http://cirnetwork.ca/research-study/vaccinating-after-chemotherapy-or-hematopoietic-stem-cell-transplant/

STUDY SPOTLIGHT- Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery (ARST-1321)

This randomized phase II/III trial studies how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery.

  • Official Title: Pazopanib Neoadjuvant Trial in Non-rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754)
  • NOL Date: Canadian NOL 31-Oct-2014
  • Cooperative Group: Canadian Cancer Trials Group (CCTG)
  • NCT02180867, COG  Protocol ARST-1321
  • For more information see, https://clinicaltrials.gov/ct2/show/NCT02180867

STUDY SPOTLIGHT: TINI – Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

The purpose of this phase I/II study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants.

STUDY SPOTLIGHT: Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors (PREVENT-HF; COG ALTE1621)

This trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer.

  • Official Title: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
  • NOL Date: Canadian NOL 24-May-2016
  • Cooperative Group: Children’s Oncology Group, sponsored in Canada by C17 for pediatric centres
  • NCT02717507, COG  Protocol ALTE-1621
  • https://clinicaltrials.gov/ct2/show/NCT02717507