Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

NCT03020030 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 16-001
• Study Type: interventional
• Target: 560
• Locations: 2 countries
• Sites: 9

Brief Summary

Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out the normal blood cells in the bone marrow so that the body cannot make enough normal blood cells. ALL is always fatal if it is not treated. With current treatments, most children and adolescents with this disease will be cured. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all children and adolescents with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are called "risk factors". This trial is studying the use of a new, updated set of risk factors to decide how strong the treatment will be. The study also will test a new way of dosing a chemotherapy drug called pegaspargase (which is part of the standard treatment for ALL) based on checking levels of the drug in the blood and adjusting the dose based on the levels.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

• Complete Remission Rate

  After 1 month of treatment (Induction IA) for all participants, assessed at the end of first month of treatment in all participants through study completion (expected to take 4-5 years to accrue)

• Event-Free Survival

  From registration to the time of induction failure, relapse, death, or second malignancy, whichever came first, assessed up to 60 months.

Secondary Outcomes (4)

• Overall Survival

  From registration to the time of death from any cause, assessed up to 60 months.

• Disease Free Survival

  From randomization or direct assignment (for participants who achieved a complete remission and were assigned a final risk group) to the time of relapse, death, or second malignancy, whichever came first, assessed up to 60 months.

• Nadir Serum Asparaginase Activity (NSAA)

  During post-induction therapy with 30-weeks of pegaspargase (15 doses), collected during the first 6 months of therapy for all participants through study completion (expected to take 4-5 years to accrue)

• Non-allergic Asparaginase Toxicity

  During post-induction therapy with 30-weeks of pegaspargase (15 doses). collected during the first 6 months of therapy for all participants through study completion (expected to take 4-5 years to accrue)

Study Arms (10)

Initial Low Risk (Initial LR)

OTHER

Meets all the following criteria: B-ALL, Age 1-\<15 years, WBC \< 50,000/microliter, CNS-1 or CNS-2, no BCR-ABL1, no iAMP21, and no VHR characteristics. Treated with Induction IA (vincristine, dexamethasone, pegaspargase), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: Cyclophosphamide; Drug: CYTARABINE; Drug: DEXAMETHASONE; Drug: HYDROCORTISONE; Drug: LEUCOVORIN CALCIUM; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: Vincristine

Initial High Risk (Initial HR)

OTHER

Meets at least one of the following criteria: Age \>=15 years, WBC \>=50,000/microliter, CNS-3, T-ALL, iAMP21, BCR-ABL1 And: No VHR characteristics Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: Cyclophosphamide; Drug: CYTARABINE; Drug: DEXAMETHASONE; Drug: Dexrazoxane; Drug: Doxorubicin; Drug: HYDROCORTISONE; Drug: LEUCOVORIN CALCIUM; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: Vincristine

Initial Very High Risk (Initial VHR)

OTHER

Any of the following are present: IKZF1 deletion, MLL (KMT2A) rearrangement, low hypodiploidy, t(17;19) Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: Cyclophosphamide; Drug: CYTARABINE; Drug: DASATINIB; Drug: DEXAMETHASONE; Drug: Dexrazoxane; Drug: Doxorubicin; Drug: ETOPOSIDE; Drug: HYDROCORTISONE; Drug: LEUCOVORIN CALCIUM; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: NELARABINE; Drug: Vincristine

Final Low Risk (Final LR)

OTHER

Initial Low Risk and Low MRD (\<0.0001) at first time point (Day 32) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, methotrexate, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: CYTARABINE; Drug: DEXAMETHASONE; Drug: HYDROCORTISONE; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: Vincristine

Final Intermediate Risk (Final IR)

OTHER

Initial High Risk and Low MRD (\<0.0001) at first time point (Day 32) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: CYTARABINE; Drug: DEXAMETHASONE; Drug: Dexrazoxane; Drug: Doxorubicin; Drug: HYDROCORTISONE; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: Vincristine

Final High Risk (Final HR)

OTHER

Initial Low Risk or Initial High Risk with High MRD (\>=0.0001) at first time point (Day 32) but low MRD (\<0.001) at second time point (week 10-12) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: CYTARABINE; Drug: DEXAMETHASONE; Drug: Dexrazoxane; Drug: Doxorubicin; Drug: HYDROCORTISONE; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: Vincristine

Final Very High Risk (Final VHR)

OTHER

Initial VHR or any patient with high MRD (\>=0.001) at second time point (week 10-12) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: Consolidation IB/B-ALL (High-dose methotrexate + leucovorin, cyclophosphamide, etoposide, IT chemotherapy); Consolidation IB/T-ALL (nelararbine, cyclophosphamide, etoposide); Consolidation IC (High-dose cytarabine, etoposide, dexamethasone, pegaspargase \[by direct assignment\], IT chemotherapy); CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). Dasatinib administered daily during all phases to pts with ABL1-class fusions. All treatment completed 24 months from date of complete remission.

Drug: Pegaspargase; Drug: Erwinia asparaginase; Drug: Cyclophosphamide; Drug: CYTARABINE; Drug: DASATINIB; Drug: DEXAMETHASONE; Drug: Dexrazoxane; Drug: Doxorubicin; Drug: ETOPOSIDE; Drug: HYDROCORTISONE; Drug: LEUCOVORIN CALCIUM; Drug: MERCAPTOPURINE; Drug: METHOTREXATE; Drug: NELARABINE; Drug: Vincristine

Fixed Dose Pegaspargase

ACTIVE COMPARATOR

Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks at standard fixed-dose (2500 IU/m2/dose).

Drug: Pegaspargase; Drug: Erwinia asparaginase

Reduced Dose (PK-Adjusted) Pegaspargase

EXPERIMENTAL

Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks beginning at a reduced dose (2000 IU/m2/dose); subsequent doses adjusted based on nadir serum asparaginase activity (NSAA) levels, with goal of maintaining NSAA between 0.4 and 1.0 IU/mL. Closed to Enrollment.

Drug: Pegaspargase; Drug: Erwinia asparaginase

Direct Assignment

OTHER

All VHR patients, and any Final LR, IR, HR patients who decline randomization: Assigned to receive standard dosing of pegaspargase (15 doses of pegaspargase every 2-weeks at standard fixed-dose; 2500 IU/m2/dose).

Drug: Pegaspargase; Drug: Erwinia asparaginase

Interventions

Pegaspargase DRUG

Arm A: Standard/Fixed Dose Pegaspargase (2500 IU/m2 every 2 weeks) Arm B: Reduced Dose (PK-adjusted) Pegaspargase (Starting Dose: 2000 IU/m2) Arm X: Directly Assigned Standard Dose (2500 IU/m2): For all VHR and patients who decline randomization

Direct Assignment; Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Fixed Dose Pegaspargase; Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR); Reduced Dose (PK-Adjusted) Pegaspargase

Erwinia asparaginase DRUG

Only for patients with Pegaspargase allergy or silent inactivation.

Also known as: ERWINAZE®, ERWINIA CHRYSANTHEMI, ERWINASE®

Direct Assignment; Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Fixed Dose Pegaspargase; Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR); Reduced Dose (PK-Adjusted) Pegaspargase

Cyclophosphamide DRUG

Standard of Care

Also known as: CYTOXAN

Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

CYTARABINE DRUG

Standard of Care

Also known as: CYTOSINE ARABINOSIDE, ARA-C, CYTOSAR®

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

DASATINIB DRUG

Standard of Care

Final Very High Risk (Final VHR); Initial Very High Risk (Initial VHR)

DEXAMETHASONE DRUG

Standard of Care

Also known as: DECADRON®, HEXADROL®,, DEXONE®,, DEXAMETH®

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

Dexrazoxane DRUG

Standard of Care

Also known as: Zinecard

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Very High Risk (Initial VHR)

Doxorubicin DRUG

Standard of Care

Also known as: ADRIAMYCIN®

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Very High Risk (Initial VHR)

ETOPOSIDE DRUG

Standard of Care

Also known as: VePesid

Final Very High Risk (Final VHR); Initial Very High Risk (Initial VHR)

HYDROCORTISONE DRUG

Standard of Care

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

LEUCOVORIN CALCIUM DRUG

Standard of Care

Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

MERCAPTOPURINE DRUG

Standard of Care

Also known as: 6-MP

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

METHOTREXATE DRUG

Standard of Care

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

NELARABINE DRUG

Standard of Care

Final Very High Risk (Final VHR); Initial Very High Risk (Initial VHR)

Vincristine DRUG

Standard of Care

Also known as: Oncovin

Final High Risk (Final HR); Final Intermediate Risk (Final IR); Final Low Risk (Final LR); Final Very High Risk (Final VHR); Initial High Risk (Initial HR); Initial Low Risk (Initial LR); Initial Very High Risk (Initial VHR)

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmed diagnosis of acute lymphoblastic leukemia. Diagnosis should be made by bone marrow aspirate or biopsy demonstrating ≥ 25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype.
• \-- For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-ALL or T-ALL phenotype is sufficient for registration onto the study. Bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy.
• Prior Therapy: No prior therapy is allowed except for the following:
• Corticosteroids: Short courses of corticosteroid (defined as ≤ 7 days of corticosteroids within the 4-weeks preceding registration) are allowed prior to registration.
• \--- Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4-weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible.
• IT cytarabine: A single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration. If patient has received IT cytarabine prior to registration, Day 1 IT cytarabine should not be administered.
• Emergent Radiation Therapy: Emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration.
• Age: 365 days to \< 22 years
• Direct bilirubin \< 1.4 mg/dL (23.9 micromoles/L).
• Ability of parent or guardian to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Mature B-cell (Burkitt's) ALL (defined by the presence of surface immunoglobulin and/or the t(8;14)(q24;q32), t(8;22), or t(2;8) translocation and/or c-myc-gene rearrangement).
• World Health Organization diagnostic criteria of mixed phenotype acute leukemia (MPAL) or leukemia of ambiguous lineage
• Any chemotherapy or radiotherapy for previous malignancy are not eligible.
• Treatment in past with any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (eg, rheumatologic or autoimmune condition).
• Currently receiving any investigational agents.
• Known HIV-positivity
• Uncontrolled intercurrent illness including, but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (eg, with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic and/or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.
• History of a previous malignancy. Exception: Individuals with a previous malignancy treated with surgery only (no chemotherapy or radiotherapy) more than 5 years prior to registration may be enrolled.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Servier: collaborator

Study Sites (9)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Hasbro Children's Hospital / Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Hospital Sainte Justine, University of Montreal

Montreal, Quebec, Canada

Location

Centre Hospitalier U. de Quebec

Québec, Quebec, Canada

Location

Related Publications (2)

• Park Y, K C N, Willekens J, Patel C, Savage BA, Lin H, Paneque A, Daly R, Thrope A, Burns MA, Welch JJG, Kahn JM, Kelly KM, Tran TH, Michon B, Gennarini L, Silverman LB, Sands SA, Cole PD. Treatment-Related Changes in Cerebrospinal Fluid Markers of Oxidative Stress and Neurodegeneration during Therapy for Childhood Acute Lymphoblastic Leukemia. Cancer Epidemiol Biomarkers Prev. 2025 Nov 3;34(11):2015-2024. doi: 10.1158/1055-9965.EPI-25-1058.

  PMID: 40905823 DERIVED

• Tran TH, Langlois S, Meloche C, Caron M, Saint-Onge P, Rouette A, Bataille AR, Jimenez-Cortes C, Sontag T, Bittencourt H, Laverdiere C, Lavallee VP, Leclerc JM, Cole PD, Gennarini LM, Kahn JM, Kelly KM, Michon B, Santiago R, Stevenson KE, Welch JJG, Schroeder KM, Koch V, Cellot S, Silverman LB, Sinnett D. Whole-transcriptome analysis in acute lymphoblastic leukemia: a report from the DFCI ALL Consortium Protocol 16-001. Blood Adv. 2022 Feb 22;6(4):1329-1341. doi: 10.1182/bloodadvances.2021005634.

  PMID: 34933343 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pegaspargase; asparaginase erwinia chrysanthemi recombinant; Asparaginase; Cyclophosphamide; Cytarabine; Dasatinib; Dexamethasone; Calcium Dobesilate; Dexrazoxane; Doxorubicin; Etoposide; Hydrocortisone; Leucovorin; Mercaptopurine; Methotrexate; nelarabine; Vincristine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Thiazoles; Sulfur Compounds; Azoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Razoxane; Diketopiperazines; Piperazines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Melissa Burns, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 13, 2017
• Study Start: March 3, 2017
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 1, 2034
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (2)