ClinicalTrials.gov
ClinicalTrials.gov Menu

International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01802814
Recruitment Status : Recruiting
First Posted : March 1, 2013
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
Australian & New Zealand Childhood Hematology & Oncology Group (Co-Sponsor Australia/NZ)
St. Anna Kinderkrebsforschung (Co-Sponsor Austria)
EORTC (Co-Sponsor Belgium)
University Hospital Motol (Co-Sponsor Czech Republic)
Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)
Turku University (Co-Sponsor Finland)
CHU de Nice (Co-Sponsor France)
Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)
Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)
Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy)
National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan)
Prinses Máxima Centrum (Co-Sponsor Netherlands)
Oslo University Hospital (Co-Sponsor Oslo)
Medical University of Wroclaw (Co-Sponsor Poland)
Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa)
Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)
University Hospital Stockholm (Co-Sponsor Sweden)
University Children's Hospital Zurich (Co-Sponsor Switzerland)
Central Manchester University (Co-Sponsor UK)
Information provided by (Responsible Party):
PD Dr. Arend von Stackelberg, Charite University, Berlin, Germany

Brief Summary:
The main goal of this study is to improve the outcome of children and adolescents with standard risk 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia (ALL) Drug: SR-A + Epratuzumab Drug: SR-B + Epratuzumab Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
Actual Study Start Date : May 2014
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: SR-A
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.
Active Comparator: SR-A + Epratuzumab
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.
Drug: SR-A + Epratuzumab
Other Name: Epratuzumab

No Intervention: SR-B
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.
Active Comparator: SR-B + Epratuzumab
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.
Drug: SR-B + Epratuzumab
Other Name: Epratuzumab




Primary Outcome Measures :
  1. SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1) [ Time Frame: Up to 9 years ]
    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

  2. SR consolidation +/- epratuzumab (randomisation 2) [ Time Frame: Up to 9 years ]
    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


Secondary Outcome Measures :
  1. SR induction/consolidation [ Time Frame: Up to 9 years ]
    SR induction/consolidation: comparison of OS, toxicity, rate of CR2, and rate of MRD between treatment groups

  2. SR consolidation +/- epratuzumab [ Time Frame: Up to 9 years ]
    SR consolidation +/- epratuzumab: comparison of OS, toxicity, MRD levels, rate of MRD and evaluation of pharmacokinetic parameters of Epratuzumab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
  • Children less than 18 years of age at inclusion
  • Meeting SR criteria: late isolated or late/early combined BCP 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
  • No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL Inclusion criteria specific for the epratuzumab randomization
  • Precursor B-cell immunophenotype. A specific CD22 expression level is not required
  • M1 or M2 status of the bone marrow after induction

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802814


Contacts
Contact: Arend von Stackelberg, MD +49(0)30-450666 ext 833 arend.stackelberg@charite.de

  Show 19 Study Locations
Sponsors and Collaborators
Charite University, Berlin, Germany
Australian & New Zealand Childhood Hematology & Oncology Group (Co-Sponsor Australia/NZ)
St. Anna Kinderkrebsforschung (Co-Sponsor Austria)
EORTC (Co-Sponsor Belgium)
University Hospital Motol (Co-Sponsor Czech Republic)
Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)
Turku University (Co-Sponsor Finland)
CHU de Nice (Co-Sponsor France)
Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)
Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)
Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy)
National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan)
Prinses Máxima Centrum (Co-Sponsor Netherlands)
Oslo University Hospital (Co-Sponsor Oslo)
Medical University of Wroclaw (Co-Sponsor Poland)
Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa)
Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)
University Hospital Stockholm (Co-Sponsor Sweden)
University Children's Hospital Zurich (Co-Sponsor Switzerland)
Central Manchester University (Co-Sponsor UK)
Investigators
Principal Investigator: Arend von Stackelberg, MD University Hospital of Berlin - Charité

Additional Information:
Responsible Party: PD Dr. Arend von Stackelberg, PD Dr. med. Arend von Stackelberg, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01802814     History of Changes
Other Study ID Numbers: IntReALL SR 2010
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by PD Dr. Arend von Stackelberg, Charite University, Berlin, Germany:
ALL

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases