International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01802814 |
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Recruitment Status :
Active, not recruiting
First Posted : March 1, 2013
Last Update Posted : February 13, 2023
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Sponsor:
Charite University, Berlin, Germany
Collaborators:
Australian & New Zealand Children's Haematology/Oncology Group
St. Anna Kinderkrebsforschung (Co-Sponsor Austria)
European Organisation for Research and Treatment of Cancer - EORTC
University Hospital Motol (Co-Sponsor Czech Republic)
Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)
Turku University (Co-Sponsor Finland)
Centre Hospitalier Universitaire de Nice
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 Children's Hospital, Zurich
Central Manchester University (Co-Sponsor United Kingdom)
Information provided by (Responsible Party):
PD Dr. Arend von Stackelberg, Charite University, Berlin, Germany
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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.
| 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) |
| Actual Enrollment : | 700 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 : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
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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.This randomizaton has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
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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. This randomizaton has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
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Drug: SR-A + Epratuzumab
Other Name: Epratuzumab |
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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. This randomizaton has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
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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. This randomizaton has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
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Drug: SR-B + Epratuzumab
Other Name: Epratuzumab |
Primary Outcome Measures :
- 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
- 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 :
- 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
- 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
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| Ages Eligible for Study: | 1 Day 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 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
- 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
Locations
Show 17 study locations
Sponsors and Collaborators
Charite University, Berlin, Germany
Australian & New Zealand Children's Haematology/Oncology Group
St. Anna Kinderkrebsforschung (Co-Sponsor Austria)
European Organisation for Research and Treatment of Cancer - EORTC
University Hospital Motol (Co-Sponsor Czech Republic)
Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)
Turku University (Co-Sponsor Finland)
Centre Hospitalier Universitaire de Nice
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 Children's Hospital, Zurich
Central Manchester University (Co-Sponsor United Kingdom)
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 |
| Other Study ID Numbers: |
IntReALL SR 2010 |
| First Posted: | March 1, 2013 Key Record Dates |
| Last Update Posted: | February 13, 2023 |
| Last Verified: | February 2023 |
Keywords provided by PD Dr. Arend von Stackelberg, Charite University, Berlin, Germany:
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ALL |
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Epratuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |