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HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

NCT05740449 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-06-21

No results posted yet for this study

Summary

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol A is a phase I/II trial evaluating the safety and efficacy of Decitabine / Venetoclax and Navitoclax in children and AYA with R/R pediatric ALL/LBL

Conditions

  • Acute Lymphoblastic Leukemia, in Relapse
  • Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent
  • Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent
  • Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory
  • Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory

Interventions

DRUG

Decitabine

intravenous

DRUG

Venetoclax

oral

DRUG

Navitoclax

oral

DRUG

intrathecal chemotherapy

IT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement

Sponsors & Collaborators

  • Innovative Therapies For Children with Cancer Consortium

    collaborator OTHER

  • IBFM

    collaborator INDUSTRY

  • Fight Kids Cancer

    collaborator OTHER

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Principal Investigators

  • Michel Zwaan, Prof. Dr. · Princess Maxima Center for Pediatric Oncology

  • Andrej Lissat, MD, PhD · Charité

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2029-10-01
Completion
2029-10-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740449 on ClinicalTrials.gov