Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT03959085 : A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

1-24Age 1-24

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Lymphoblastic Leukaemia,Acute Lymphoblastic Lymphoma,Leukaemia,Lymphoma

Trial Overview Read MoreRead more

This Phase III trial is assessing whether adding a targeted therapy (inotuzumab ozogamicin) to post-induction chemotherapy for people with high risk B-cell acute lymphoblastic leukaemia improves outcomes.
 

This trial is treating patients with B Acute Lymphoblastic Leukaemia, B Lymphoblastic Lymphoma and Mixed Phenotype Acute Leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Cooperative Group

Children's Oncology Group

Other Non-Commercial Sponsor

National Cancer Institute (NCI)

Summary

The overall goal of this randomised, open-label study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukaemia. The first part of the study has two phases of therapy: Induction and Consolidation. This part will collect information on the leukaemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. In the second part of the study, patients will receive the remainder of the chemotherapy cycles with some patients randomised to receive inotuzumab. Other aims of the study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukaemia (B LLy) or Mixed Phenotype Acute Leukaemia (MPAL) when treated with B-ALL chemotherapy.

Recruiting Hospitals Read MoreRead more

Monash Children's Cancer Centre
Clayton
Ms Narmatha Kuru
CCCclinicaltrials@monashhealth.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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