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Trial record 1 of 2 for:    A Treatment study protocol of the ALLTogether Consortium for children and young adults (1-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)
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A Treatment Protocol for Participants 1-45 Years With Acute Lymphoblastic Leukaemia

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ClinicalTrials.gov Identifier: NCT03911128
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : December 23, 2020
Sponsor:
Collaborators:
Nordic Society for Pediatric Hematology and Oncology
The Swedish Childhood Cancer Foundation
NordForsk
Information provided by (Responsible Party):
Mats Heyman, Karolinska University Hospital

Tracking Information
First Submitted Date March 26, 2019
First Posted Date April 10, 2019
Last Update Posted Date December 23, 2020
Actual Study Start Date August 29, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2019)
  • Event-free survival (EFS) compared to historical controls [ Time Frame: 5 year ]
  • Overall survival (OS) compared to historical controls [ Time Frame: 5 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Treatment Protocol for Participants 1-45 Years With Acute Lymphoblastic Leukaemia
Official Title A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (1-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study
Brief Summary

The pilot study collects the experience of previously successful treatment of children and young adults, with ALL from a number of well-renowned study groups into a new platform 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 trials included in the study-design.

The pilot study will be implemented as a master protocol without study specific interventions, thus as an observational study. The pilot will run approximately one year before the start of the master protocol including interventions and is crucial to optimise registration systems, collaborations with vendors, logistics and data-checks before starting the main study.

The study only includes "standard of care" treatment of the master protocol.

Detailed Description

The aims of the ALLTogether study are to improve survival and quality of survival for children and young adults with ALL. ALL in young people has excellent outcome with >90% survival in children and about 75% in young adults. However, patients still die of disease - after relapse as a result of under-treatment.

Furthermore, a considerable fraction of younger patients are over-treated: All patients risk treatment-related death and some suffer long-term side-effects or secondary cancer. The rates of death from disease and death from therapy are almost the same for children. To show improvement with such good survival, large populations are needed.

Study groups from the five Nordic countries, Estonia and Lithuania (NOPHO), the UK (UKALL), the Netherlands (DCOG), Germany (COALL), Belgium (BSPHO), Ireland (SHOP) and France (SFCE) have designed a common treatment protocol as new standard of care for children and young adults with ALL. The risk-stratification is based on a novel, personalised algorithm using clinical characteristics, genetic changes in the leukaemia and response to therapy.

The protocol will, based on a personalised risk-approach, define a platform for diagnosis and treatment onto which randomized as well as non-randomised interventions and translational studies can be added.

High-risk B-lineage patients may be stratified to Chimeric Antigen Receptor T-cell (CAR-T) therapy as an alternative to high-risk blocks and stem-cell transplant to reduce the side-effects.

Translational and other therapy-related research will be promoted by the common master protocol.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • Blood/blood plasma
  • Cerebrospinal fluid
  • Bone marrow
Sampling Method Probability Sample
Study Population Participants 1-45 years with newly diagnosed acute lymphoblastic leukaemia. The protocol has no gender-bias. The total estimated recruitment in the pilot study is 235 participants.
Condition Leukemia, Acute Lymphoblastic
Intervention Other: Observational
Observational study - no intervention
Study Groups/Cohorts Participants with newly diagnosed ALL
Intervention: Other: Observational
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 9, 2019)
235
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2026
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants newly diagnosed with T-lineage or precursor-B (BCP) ALL. Participants with mature B-ALL (Surface Ig positive) or ambiguous lineage acute leukaemia /mixed phenotype acute leukaemia (ALAL/MPAL) are not eligible for inclusion, but ALAL/MPAL participants may be treated according to the protocol therapy as standard of care at the discretion of the treating physician and after consultation with the national PI.
  • Age ≥ 365 days and < 46 years (one day before 46th birthday) at the time of diagnosis.
  • Informed consent signed by the participant and/or parents/legal guardians according to country-specific age-related guidelines (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199 234.pdf ).
  • The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
  • The participant should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.
  • The participant should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Participants who are visiting the country as tourists should not be included. However, returning expatriates with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.
  • All female participants of childbearing potential have to have a negative pregnancy test within 2 weeks prior to the start of treatment.

Exclusion Criteria:

  • Age < 365 days at diagnosis (infant ALL) or >45 years at diagnosis.
  • Participants with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).
  • Relapse of ALL.
  • Participants with mature B-ALL (as defined by Surface Ig positivity or documented presence of one of the t(8;14), t(2;8), t(8;22) translocations and breakpoint as in B-ALL).
  • Participants with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR/ABL fusion transcript). These participants will be transferred to an adequate trial for t(9;22) if available.
  • ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory.
  • Treatment with systemic corticosteroids for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).
  • Pre-existing contraindications for treatment according to (parts of) the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).
  • Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the participants to cooperate and comply with the study procedures.
  • Female participants who are pregnant at the time of diagnosis.
  • Male or female participants who are sexually active and are unwilling to use adequate contraception during therapy.
  • Female participants, who are breast-feeding.
  • Essential data missing (in consultation with the protocol chair).
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 45 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mats Heyman, M.D. PhD +46 8 517 704 07 mats.heyman@ki.se
Contact: Karin Flood, M.Sc. +46 70 321 49 22 karin.flood@ki.se
Listed Location Countries Denmark,   Finland,   Iceland,   Lithuania,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03911128
Other Study ID Numbers ALLTogether1 pilot
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be entered into the study database. The data will only be used to inform the coming main study regarding safety and overall outcomes of the master protocol.
Responsible Party Mats Heyman, Karolinska University Hospital
Study Sponsor Mats Heyman
Collaborators
  • Nordic Society for Pediatric Hematology and Oncology
  • The Swedish Childhood Cancer Foundation
  • NordForsk
Investigators
Study Chair: Mats Heyman, M.D. PhD Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date December 2020