A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Summary

ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.

Conditions

• Leukemia, Acute Lymphoblastic

Interventions

DRUG

Omitted Doxorubicin

Omission of IV Doxorubicin

DRUG

Omitted Vincristine+Dexamethasone pulses

Omission of Vincristine+Dexamethasone pulses

DRUG

Inotuzumab Ozogamicin+Standard Maintenance Therapy

Addition of IV Inotuzumab ozogamicin before Maintenance Therapy

DRUG

Imatinib

p.o. Imatinib

DRUG

6-tioguanine+Standard Maintenance Therapy

Addition of p.o. 6-tioguanine to Standard Maintenance Therapy

DRUG

Blinatumomab

IV Blinatumomab

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• The Swedish Childhood Cancer Foundation

  collaborator UNKNOWN

• Pfizer

  collaborator INDUSTRY

• Servier

  collaborator INDUSTRY

• NordForsk

  collaborator UNKNOWN

• Aamu Pediatric Cancer Foundation

  collaborator UNKNOWN

• German Society for Pediatric Oncology and Hematology GPOH gGmbH

  collaborator OTHER

• Clinical Trial Center North (CTC North GmbH & Co. KG)

  collaborator OTHER

• Belgium Health Care Knowledge Centre

  collaborator OTHER_GOV

• Karolinska Institutet

  collaborator OTHER

• Cancer Research UK

  collaborator OTHER

• Fundação Rui Osório de Castro

  collaborator UNKNOWN

• Acreditar - Associação de Pais e Amigos das Crianças com Cancro

  collaborator UNKNOWN

• Grupo Português De Leucemias Pediátricas

  collaborator UNKNOWN

• Amgen

  collaborator INDUSTRY

• Nova Laboratories Limited

  collaborator INDUSTRY

• Danish Child Cancer Foundation

  collaborator OTHER

• Danish Cancer Society

  collaborator OTHER

• The Novo Nordic Foundation

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Direction Générale de l'Offre de Soins

  collaborator OTHER_GOV

• Swedish Cancer Society

  collaborator OTHER

• Mats Heyman

  lead OTHER

Principal Investigators

• Mats Heyman, MD, PhD · Karolinska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

0 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-13

Primary Completion

2033-06-30

Completion

2033-06-30

FDA Drug

Yes

Countries

• Belgium
• Denmark
• Estonia
• Finland
• France
• Germany
• Iceland
• Ireland
• Lithuania
• Netherlands
• Norway
• Portugal
• Spain
• Sweden
• United Kingdom

Study Locations