A Treatment Protocol for Participants 1-45 Years With Acute Lymphoblastic Leukaemia
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| ClinicalTrials.gov Identifier: NCT03911128 |
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Recruitment Status :
Recruiting
First Posted : April 10, 2019
Last Update Posted : December 23, 2020
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Leukemia, Acute Lymphoblastic | Other: Observational |
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 |
| Estimated Enrollment : | 235 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | August 29, 2019 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Participants with newly diagnosed ALL |
Other: Observational
Observational study - no intervention |
- Event-free survival (EFS) compared to historical controls [ Time Frame: 5 year ]
- Overall survival (OS) compared to historical controls [ Time Frame: 5 year ]
Biospecimen Retention: Samples With DNA
- Blood/blood plasma
- Cerebrospinal fluid
- Bone marrow
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: | 1 Year to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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).
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): NCT03911128
| 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 |
Show 41 study locations
| Study Chair: | Mats Heyman, M.D. PhD | Karolinska University Hospital |
| Responsible Party: | Mats Heyman, MD, Associate Professor, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT03911128 |
| Other Study ID Numbers: |
ALLTogether1 pilot |
| First Posted: | April 10, 2019 Key Record Dates |
| Last Update Posted: | December 23, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Leukemia Acute Lymphoblastic ALL ALLTogether Leukaemia |
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |