NCT02393859 : Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

0-17Age 0-17

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Lymphoblastic Leukaemia

Trial Overview Read MoreRead more

This phase III trial is trying to determine whether blinatumomab (a drug) is better as a consolidation therapy than standard chemotherapy for patients with Acute Lymphoblastic Leukaemia (ALL).
 

This trial is treating patients with Acute Lymphoblastic Leukaemia.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

Commercial Sponsor

AMGEN

Summary

B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated. Patients enrolled in the initial phase of the study will be randomized in a 1:1 ratio to receive either one cycle of blinatumomab or one block of standard high-risk consolidation chemotherapy. Blinatumomab is administered as a continuous intravenous infusion (CIVI). One cycle of blinatumomab treatment includes 4 weeks of CIVI of blinatumomab. An interim analysis will be performed and a data monitoring committee will provide a recommendation to either continue with the original study design, or to adapt the treatment arms and randomize subsequent patients to either three cycles of blinatumomab or three blocks of high-risk consolidation chemotherapy. After completing consolidation therapy, the patients should undergo alloHSCT depending on their bone marrow status. THe patients will be followed up for up to 36 months after alloHSCT.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Ms Kahlia Fox
kahlia.fox@mcri.edu.au
(03) 9345 6214

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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