International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

NCT01802814 | Completed Phase 3 DMC

• 1 other identifier: IntReALL SR 2010
• Study Type: interventional
• Target: 700
• Locations: 16 countries
• Sites: 16

Brief Summary

The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Keywords

ALL

Outcome Measures

Primary Outcomes (2)

• SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1)

  SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1): 10% pEFS superiority of arm B above a 65% pEFS at 4 years of arm A

  Up to 9 years

• SR consolidation +/- epratuzumab (randomisation 2)

  SR consolidation +/- epratuzumab (randomisation 2): 10% pEFS superiority of the arm with epratuzumab above an expected 74% pEFS at 4 years of the standard arm

  Up to 9 years

Secondary Outcomes (2)

• SR induction/consolidation

  Up to 9 years

• SR consolidation +/- epratuzumab

  Up to 9 years

Study Arms (4)

SR-A

NO INTERVENTION

Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized not to receive epratuzumab.This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

SR-A + Epratuzumab

ACTIVE COMPARATOR

Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

Drug: SR-A + Epratuzumab

SR-B

NO INTERVENTION

Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized not to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

SR-B + Epratuzumab

ACTIVE COMPARATOR

Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.

Drug: SR-B + Epratuzumab

Interventions

SR-A + Epratuzumab DRUG

Also known as: Epratuzumab

SR-A + Epratuzumab

SR-B + Epratuzumab DRUG

Also known as: Epratuzumab

SR-B + Epratuzumab

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
• Meeting SR criteria: late isolated or late/early combined B-cell precursor (BCP) bone marrow (BM) relapse, any late/early isolated extramedullary relapse
• Patient enrolled in a participating centre
• Written informed consent
• Start of treatment falling into the study period
• Precursor B-cell immunophenotype. A specific CD22 expression level is not required
• M1 or M2 status of the bone marrow after induction

You may not qualify if:

• BCR-ABL / t(9;22) positive ALL
• Pregnancy or positive pregnancy test (urine sample positive for β-HCG \> 10 U/l)
• Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 2 years after end of antileukemic therapy
• Breast feeding
• Relapse post allogeneic stem-cell transplantation
• The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
• No consent is given for saving and propagation of pseudonymized medical data for study reasons
• Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
• Karnovsky / Lansky score \< 50%
• Subjects unwilling or unable to comply with the study procedures
• Subjects who are legally detained in an official institute

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Australian & New Zealand Children's Haematology/Oncology Group: collaborator
• St. Anna Kinderkrebsforschung (Co-Sponsor Austria): collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• University Hospital, Motol: collaborator
• Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen): collaborator
• Turku University (Co-Sponsor Finland): collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Our Lady's Chilrden's Hospital (Co-Sponsor Ireland): collaborator
• Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel): collaborator
• Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy): collaborator
• National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan): collaborator
• Prinses Máxima Centrum (Co-Sponsor Netherlands): collaborator
• Oslo University Hospital (Co-Sponsor Oslo): collaborator
• Medical University of Wroclaw (Co-Sponsor Poland): collaborator
• Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa): collaborator
• Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain): collaborator
• University Children's Hospital, Zurich: collaborator
• Central Manchester University (Co-Sponsor United Kingdom): collaborator

Study Sites (17)

Australian & New Zealand Childhood Hematology & Oncology Group

Clayton, Victoria, 3168, Australia

Location

St. Anna Kinderkrebsforschung, CCRI

Vienna, 1090, Austria

Location

Hòpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

University Hospital Motol

Prague, Czechia

Location

Copenhagen University Hospital (Rigshospitalet)

Copenhagen, 2100, Denmark

Location

Turku University Central Hospital

Turku, SF-20520, Finland

Location

CHU Nice

Nice, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Tel Aviv Sourasky Medical Centre

Tel Aviv, 64239, Israel

Location

Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

Location

St.Lukes International Hospital

Tokyo, Japan

Location

Prinses Máxima Centrum, Lundlaan

Utrecht, Netherlands

Location

Oslo University Hospital

Oslo, 0027, Norway

Location

Dpt. SCT and Hematology/Oncology University Wroclaw

Wroclaw, 50354, Poland

Location

Instituto Português de Oncologia de Lisboa

Lisbon, Portugal

Location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

Related Links

• Public Website of the FP7 Collaborative Project "IntReALL"

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Receptors, Scavenger; epratuzumab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, LDL; Receptors, Lipoprotein

Study Officials

• Arend von Stackelberg, MD

  University Hospital of Berlin - Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Arend von Stackelberg

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: March 1, 2013
• Study Start: May 1, 2014
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

AU (1); PL (1); IT (1); DK (1); IL (1); FR (1); NL (1); CZ (1); BE (1); JP (1); CH (1); FI (1); NO (1); DE (1); GB (1); PT (1)