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A Treatment Study Protocol for Participants 1-45 Years With Acute Lymphoblastic Leukaemia

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: NCT04307576
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
The Swedish Research Council
The Swedish Childhood Cancer Foundation
Pfizer
Servier
NordForsk
Aamu Pediatric Cancer Foundation
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Clinical Trial Center North (CTC North GmbH & Co. KG)
Belgium Health Care Knowledge Centre
Karolinska Institutet
Cancer Research UK
Fundação Rui Osório de Castro
Acreditar - Associação de Pais e Amigos das Crianças com Cancro
Grupo Português De Leucemias Pediátricas
Amgen
Nova Laboratories Limited
Danish Child Cancer Foundation
Danish Cancer Society
The Novo Nordic Foundation
Information provided by (Responsible Party):
Mats Heyman, Karolinska University Hospital

Brief Summary:
ALLTogether 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 master 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 and interventional trials included in the study-design.

Condition or disease Intervention/treatment Phase
Leukemia, Acute Lymphoblastic Drug: Omitted Doxorubicin Drug: Omitted Vincristine+Dexamethasone pulses Drug: Inotuzumab Ozogamicin+Standard Maintenance Therapy Drug: Imatinib Drug: 6-tioguanine+Standard Maintenance Therapy Drug: Blinatumomab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6430 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Master protocol with risk-stratification. The risk-stratified groups will proceed to non-randomised or randomised interventions in single arm (TKI) and (Blinatumomab) and parallel (R1/R2/R3) models respectively.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALLTogether1 - 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)
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2032


Arm Intervention/treatment
No Intervention: R1 - SR standard arm
Standard risk arm receiving standard treatment (Delayed Intensification including Doxorubicin).
Experimental: R1 - SR experimental arm
Standard risk arm, receiving Delayed Intensification without Doxorubicin IV 3 x 30 mg/m2/dose.
Drug: Omitted Doxorubicin
Omission of IV Doxorubicin

No Intervention: R2 - IR-low standard arm
Standard treatment with Delayed Intensification including Doxorubicin and Maintenance including Vincristine+Dexamethasone pulses.
Experimental: R2 - IR-low experimental arm A
Standard treatment with omission of Doxorubicin IV 3 x 30 mg/m2/dose in the Delayed Intensification phase.
Drug: Omitted Doxorubicin
Omission of IV Doxorubicin

No Intervention: R3 - IR-high standard arm
Intermediate risk high arm receiving Standard Maintenance Therapy.
Experimental: R3-InO - IR-high experimental arm
Inotuzumab IV 0,5 mg/m2, given on days 253, 260, 267 and on days 274, 281, 288 before start of Standard Maintenance Therapy.
Drug: Inotuzumab Ozogamicin+Standard Maintenance Therapy
Addition of IV Inotuzumab ozogamicin before Maintenance Therapy
Other Name: Besponsa+Maintenance Therapy

Experimental: ABL-class fusions intervention
Imatinib p.o. 340 mg/m2 given daily from day 15 or 30 (depending on age) to the end of therapy (week 106) in addition to Standard IR-high chemotherapy.
Drug: Imatinib
p.o. Imatinib

Experimental: R3-TEAM - IR-high experimental arm
6-tioguanine p.o, 2,5-12,5 mg/m2, given daily in addition to Standard Maintenance Therapy.
Drug: 6-tioguanine+Standard Maintenance Therapy
Addition of p.o. 6-tioguanine to Standard Maintenance Therapy

Experimental: ALLTogether1 DS Blinatumomab intervention
Blinatumomab IV, 5 mcg/m2/day up to 28 mcg/day (detailed dosing in protocol) continous infusion. Two 28 day courses with a two week treatment free interval in between. Blinatumomab courses replace Consolidation 1 and Consolidation 2 in the standard protocol adapted for Down syndrome patients.
Drug: Blinatumomab
IV Blinatumomab
Other Name: Blincyto

Experimental: R2 - IR-low experimental arm B
Standard treatment with omission of monthly pulses of Vincristine IV 1,5 mg/m2/dose and 5 days of Dexamethasone p.o. 6 mg/m2/day in the Maintenance Phase.
Drug: Omitted Vincristine+Dexamethasone pulses
Omission of Vincristine+Dexamethasone pulses




Primary Outcome Measures :
  1. Event-free survival (EFS) for the whole protocol [ Time Frame: 5 year estimates from the time of diagnosis will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    The primary endpoint for the whole protocol (compared with the legacy protocols of the participating study-groups forming the consortium) is event-free survival (EFS) - as defined in the protocol.

  2. Event-free survival (EFS) for the TKI intervention [ Time Frame: From the start of TKI (day 15 or day 30), 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up for all interventions except Inotuzumab-randomisation (minimum 2-year follow-up). ]
    The primary endpoint for the TKI intervention is event-free survival (EFS) - as defined in the protocol, from the start of TKI until event or end of follow-up

  3. Disease-free survival (DFS) R1 + R2 [ Time Frame: 5 and 8 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    The primary endpoint for Randomisation 1 and 2 is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation

  4. Disease-free survival (DFS) R3 [ Time Frame: 5 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 2-year follow-up ]
    The primary endpoint for Randomisation 3 and the ABL-class fusion intervention is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation (R3) and the start of TKI-therapy (ABL-class fusion intervention).

  5. MRD response after 1 cycle of Blinatumomab [ Time Frame: End of first Blinatumomab infusion +/- 1 week ]
    Fraction of patients with undetectable MRD ("Complete MRD response") at the end of one cycle of Blinatumomab (+/- 1 week)


Secondary Outcome Measures :
  1. Overall survival (OS) for the whole protocol [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Overall survival defined as time from diagnosis to death or end of follow-up for surviving patients.

  2. Overall survival (OS) for R1 + R2 [ Time Frame: 5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Overall survival defined as time from randomisation to death or end of follow-up for surviving patients.

  3. Overall survival (OS) for R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Overall survival defined as time from randomisation to death or end of follow-up for surviving patients.

  4. Overall survival (OS) for R3-TEAM associated with DNA-TG [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Overall survival as defined above in relation to DNA-TG.

  5. Overall survival (OS) for TKI [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up (TKI). ]
    Overall survival defined as time from start of TKI to death or end of follow-up for surviving patients

  6. Overall survival (OS) for ALLTogether1 DS [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Overall survival defined as time from start of Blinatumomab to death or end of follow-up for surviving patients

  7. Induction death [ Time Frame: From diagnosis until death before remission (at the earliest, day 29) or in case of no CR day 29, completion of induction and consolidation 1 (protocol day 99 - Down) and in addition 3 high-risk blocks (protocol day 134 - all other patients) ]
    Fraction of patients who die as well as cumulative incidence of death before achieved complete remission (CR) within the time-frame described in the protocol

  8. Resistant disease [ Time Frame: From diagnosis until achieved complete remission (at the earliest, day 29) or in case of no CR day 29, assessment after induction and consolidation 1 (protocol day 99-Down patients) and in addition 3 high-risk blocks (protocol day 134-all other patients) ]
    Fraction of patients as well as cumulative incidence of resistant disease as described in the protocol. Induction death as competing risk.

  9. Cumulative incidence of relapse for the whole protocol [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from achieved complete remission until relapse as defined in the protocol or end of follow-up. Second malignancy, death in complete remission as competing events.

  10. Cumulative incidence of relapse for R1 + R2 [ Time Frame: 5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from randomisation until relapse as defined in the protocol or end of follow-up. Second malignancy, death in complete remission as competing events.

  11. Cumulative incidence relapse for R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Time from randomisation until relapse as defined in the protocol or end of follow-up. Second malignancy, death in complete remission as competing events.

  12. Cumulative incidence relapse for R3-TEAM in association with DNA-TG [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Cumulative incidence of relapse as defined for R3 in association with DNA-TG for R3-TEAM. Second malignancy, death in complete remission as competing events.

  13. Cumulative incidence CD22 negative relapse for R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Time from randomisation until relapse without expression of CD22 as defined in the protocol or end of follow-up. Second malignancy, death in complete remission and relapse with CD22 expression as competing events.

  14. Cumulative incidence relapse for TKI [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of TKI until relapse as defined in the protocol or end of follow-up. Second malignancy, death in complete remission as competing events.

  15. Cumulative incidence relapse for ALLTogether1 DS [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of Blinatumomab until relapse as defined in the protocol or end of follow-up. Second malignancy, death in complete remission as competing events.

  16. Cumulative incidence of CD19 negative relapse for ALLTogether1 DS [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of Blinatumomab until CD19 negative relapse as defined in the protocol or end of follow-up. Second malignancy, death in complete remission and CD19 positive relapse as competing events.

  17. Cumulative incidence of second malignant neoplasm (SMN) for the whole protocol [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from achieved complete remission until diagnosis of second malignant neoplasm as defined in the protocol or end of follow-up. Relapse and death in complete remission as competing events.

  18. Cumulative incidence of second malignancy for R1+R2 [ Time Frame: 5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from randomisation until diagnosis of second malignant neoplasm as defined in the protocol or end of follow-up. Relapse and death in complete remission as competing events.

  19. Cumulative incidence of second malignancy for R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up. ]
    Time from randomisation until diagnosis of second malignant neoplasm as defined in the protocol or end of follow-up. Relapse and death in complete remission as competing events.

  20. Cumulative incidence of second malignancy for R3-TEAM in association with DNA-TG [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up. ]
    Cumulative incidence of second malignancy as defined above for R3 in association with DNA-TG for R3-TEAM. Relapse and death in complete remission as competing events.

  21. Cumulative incidence of second malignancy for TKI [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from start of TKI until diagnosis of second malignant neoplasm as defined in the protocol or end of follow-up. Relapse and death in complete remission as competing events.

  22. Cumulative incidence of second malignancy for ALLTogether1 DS [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from start of Blinatumomab until diagnosis of second malignant neoplasm as defined in the protocol or end of follow-up. Relapse and death in complete remission as competing events.

  23. Cumulative incidence of death in complete remission for the whole protocol [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from achieved complete remission until death in complete remission as defined in the protocol or end of follow-up. Relapse and second malignant neoplasm as competing events.

  24. Cumulative incidence of death in complete remission for R1+R2 [ Time Frame: 5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up. ]
    Time from randomisation until death in complete remission as defined in the protocol or end of follow-up. Relapse and second malignant neoplasm as competing events.

  25. Cumulative incidence of death in complete remission for R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Time from randomisation until death in complete remission as defined in the protocol or end of follow-up. Relapse and second malignant neoplasm as competing events.

  26. Cumulative incidence of death in complete remission for TKI [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of TKI until death in complete remission as defined in the protocol or end of follow-up. Relapse and second malignant neoplasm as competing events.

  27. Cumulative incidence of death in complete remission for ALLTogether1 DS [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of Blinatumomab until death in complete remission as defined in the protocol or end of follow-up. Relapse and second malignant neoplasm as competing events.

  28. Cumulative incidence of treatment-related mortality for the whole protocol [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from diagnosis until death during induction, death in complete remission or death from second malignant neoplasm (if not related to SMN-treatment).

  29. Cumulative incidence of treatment-related mortality R1+R2 [ Time Frame: 5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up. ]
    Time from randomisation until death in complete remission or death from second malignant neoplasm (if not related to SMN-treatment).

  30. Cumulative incidence of treatment-related mortality R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Time from randomisation until death in complete remission or death from second malignant neoplasm (if not related to SMN-treatment).

  31. Cumulative incidence of treatment-related mortality TKI [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of TKI until death in complete remission or death from second malignant neoplasm (if not related to SMN-treatment).

  32. Leukaemia specific mortality for the whole protocol [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from diagnosis until death after resistant disease or relapse - as defined in the protocol.

  33. Leukaemia specific mortality for R1+R2 [ Time Frame: 5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up. ]
    Time from randomisation until death after relapse - as defined in the protocol.

  34. Leukaemia specific mortality for R3 [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up ]
    Time from randomisation until death after relapse - as defined in the protocol.

  35. Leukaemia specific mortality for TKI [ Time Frame: 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up ]
    Time from start of TKI until death after relapse - as defined in the protocol.

  36. Incidence of Adverse Events of Special Interest (AESIs) per treatment-phase in the whole protocol and TKI intervention [ Time Frame: From time of diagnosis after each treatment-phase (one extra in the middle of maintenance) and annually until 5 years from discontinuation of therapy. ]
    Cumulative incidence of 19 AESIs as defined in the protocol

  37. Incidence of Adverse Events of Special Interest (AESIs) extra assessment (R1+R2) [ Time Frame: Cumulative incidence of AESIs estimated 3 months after start of maintenance (R1+R2) and at the end of maintenance (R2) ]
    Cumulative incidence of 4 additional AESIs as defined in the protocol

  38. Incidence of Adverse Events of Special Interest (AESIs) extra assessment (R3) [ Time Frame: Cumulative incidence of AESIs estimated at the end of maintenance. ]
    Cumulative incidence of 3 additional AESIs as defined in the protocol

  39. Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) related to R3 [ Time Frame: From time of randomisation until the end of maintenance therapy (approximately 77 weeks from randomisation) ]
    Cumulative incidence of SAEs and AEs (with limitations) as defined in the protocol

  40. Quantitative measures of toxicity R1+R2 [ Time Frame: From time of randomisation, assessment after delayed intensification and 6 weeks after start of maintenance ]
    Days: in hospital, with iv antibiotics, with iv analgesics, with iv nutritional support

  41. Metabolic consequences of steroid exposure (R2) [ Time Frame: At the end of therapy (approximately 94 weeks from randomisation) and 5 years after discontinuation of treatment ]
    Measurements of BMI

  42. Association of Disease-free survival (DFS) with DNA-TG for R3-TEAM [ Time Frame: 5 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 2-year follow-up ]
    Disease-free survival (DFS) - as defined above associated with DNA-TG.

  43. Cumulative incidence of Sinusoidal Obstruction Syndrome (SOS) and Nodular Regenerative Hyperplasia (NRH) for R3-TEAM [ Time Frame: Cumulative incidence of SOS/NRH estimated at the end of follow-up. ]
    Time from randomisation until diagnosis of SOS or NRH as defined in the protocol or end of follow-up.

  44. Cumulative incidence of Osteonecrosis for R3-TEAM [ Time Frame: Cumulative incidence of osteonecrosis estimated at the end of follow-up. ]
    Time from randomisation until diagnosis of osteonecrosis as defined in the protocol or end of follow-up.

  45. Event-free survival (EFS) for ALLTogether1 DS [ Time Frame: From the start of Blinatumomab, 5 year estimate will be measured but adequate follow-up for this estimate will be ensured: at least 5 years follow-up. ]
    Event-free survival as defined in the protocol, from the start of Blinatumomab until death from any cause, relapse, second malignancy, protocol therapy failure (MRD>1% after 2 cycles blinatumomab and Augmented BFM consolidation) or end of follow-up.

  46. Incidence of Blinatumomab refractory disease for ALLTogether1 DS [ Time Frame: From the start of Blinatumomab until end of 2nd cycle of Blinatumomab (each cycle is 4 weeks followed by a 2-week treatment free period) ]
    Incidence of progressive disease under Blinatumomab treatment or MRD ≥1% at the end of the 2nd cycle of Blinatumomab.

  47. Incidence of Protocol Therapy Failure for ALLTogether1 DS [ Time Frame: From the start of Blinatumomab until the end of Consolidation 1 (85-140 days: 15-70 days of Blinatumomab therapy + 70 days of Consolidation 1) ]
    Incidence of patients who have MRD ≥1 % post 2 cycles of Blinatumomab followed by Augmented BFM consolidation, corresponding to original protocol day 99, or unchanged/increasing MRD during Augmented BFM consolidation corresponding to original protocol day 57.


Other Outcome Measures:
  1. 6-mercaptopurine and Methotrexate metabolite pharmacokinetics (i.e. Ery-TGN/MeMP/MTXpg) for R3-TEAM [ Time Frame: From start of Maintenance therapy until the end of Maintenance therapy (protocol week 37 until protocol week 108) ]
    Measurements of metabolites Ery-TGN/MeMP/MTXpg during Maintenance therapy.

  2. Abnormal liver function parameters (including hypoglycemia) for R3-TEAM [ Time Frame: From start of Maintenance therapy until the end of Maintenance therapy (protocol week 37 until protocol week 108) ]
    Liver function parameters including hypoglycemia during Maintenance therapy



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.


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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
  • Age ≥ 365 days and < 46 years (one day before 46th birthday) at the time of diagnosis.
  • Informed consent signed by the patient 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/WC500199234.pdf ).
  • The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
  • The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.
  • The patient 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. Patients who are visiting the country as tourists should not be included. However, returning expatriots with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.
  • All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.
  • For each intervention/randomisation an additional set of inclusion-criteria is provided.

Exclusion Criteria:

  • Age < 365 days at diagnosis (infant ALL) or >45 years at diagnosis.
  • Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).
  • Relapse of ALL.
  • Patients 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).
  • Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR/ABL fusion transcript). These patients 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 (>10mg/m2/day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).
  • Pre-existing contraindications to any treatment according to 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 patients to cooperate and comply with the study procedures.
  • Women of childbearing potential who are pregnant at the time of diagnosis.
  • Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required.
  • Female patients, who are breast-feeding.
  • Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).
  • For each intervention/randomisation an additional set of exclusion-criteria is provided.

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): NCT04307576


Contacts
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Contact: Global Clinical Trial Manager ALLTogether1 +46 8 524 800 00 karin.flood@ki.se

Locations
Show Show 101 study locations
Sponsors and Collaborators
Mats Heyman
The Swedish Research Council
The Swedish Childhood Cancer Foundation
Pfizer
Servier
NordForsk
Aamu Pediatric Cancer Foundation
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Clinical Trial Center North (CTC North GmbH & Co. KG)
Belgium Health Care Knowledge Centre
Karolinska Institutet
Cancer Research UK
Fundação Rui Osório de Castro
Acreditar - Associação de Pais e Amigos das Crianças com Cancro
Grupo Português De Leucemias Pediátricas
Amgen
Nova Laboratories Limited
Danish Child Cancer Foundation
Danish Cancer Society
The Novo Nordic Foundation
Investigators
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Study Chair: Mats Heyman, MD, PhD Karolinska University Hospital
Publications:

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Responsible Party: Mats Heyman, MD, Associate Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04307576    
Other Study ID Numbers: ALLTogether1
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The trial steering committee has not yet had the opportunity to discuss and decide on a plan to share IPD. Since no publication will be forthcoming from the study within at least 5 years (currently 2025), this shortcoming will be amended within a year (before 2021).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mats Heyman, Karolinska University Hospital:
Leukemia
Acute Leukemia
ALL
ALLTogether
Leukaemia
Inotuzumab ozogamicin
Besponsa
ALLTogether1
Blinatumomab
Blincyto
6-tioguanine
6-thioguanine
Additional relevant MeSH terms:
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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
Dexamethasone
Doxorubicin
Vincristine
Imatinib Mesylate
Blinatumomab
Inotuzumab Ozogamicin
Thioguanine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors