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History of Changes for Study: NCT02737306
Study of PRO 140 for Prophylaxis of Acute GVHD in Patients Undergoing RIC Allogenic Stem-Cell Transplantaton (GVHD)
Latest version (submitted January 13, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 12, 2016 None (earliest Version on record)
2 December 14, 2016 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Eligibility, Oversight and Study Identification
3 February 1, 2017 Study Status and Contacts/Locations
4 August 13, 2018 Outcome Measures, Study Status, Study Design, Contacts/Locations, Arms and Interventions, Conditions, Study Description, Study Identification and Eligibility
5 January 13, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
Comparison Format:

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Changes (Side-by-Side) for Study: NCT02737306
April 12, 2016 (v1) -- August 13, 2018 (v4)

Changes in: Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: PRO 140_CD 03_GVHD PRO 140_CD 03_GVHD
Brief Title: Study of PRO 140 for Prophylaxis of Acute GVHD in Patients With AML or MDS Undergoing Allogeneic Stem-Cell Transplant. (GVHD)Study of PRO 140 for Prophylaxis of Acute GVHD in Patients Undergoing RIC Allogenic Stem-Cell Transplantaton (GVHD)
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT). An Open-Label, Single-Arm, Phase II Multicenter Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Reduced Intensity Conditioning (RIC) Allogeneic Stem-Cell Transplantation
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2016 August 2018
Overall Status: Not yet recruitingRecruiting
Study Start: May 2016 November 2016
Primary Completion: December 2017 [Anticipated] December 2019 [Anticipated]
Study Completion: December 2018 [Anticipated] December 2019 [Anticipated]
First Submitted: March 29, 2016 March 29, 2016
First Submitted that
Met QC Criteria:
April 12, 2016 April 12, 2016
First Posted: April 13, 2016 [Estimate] April 13, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 12, 2016 August 13, 2018
Last Update Posted: April 13, 2016 [Estimate] August 15, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: CytoDyn, Inc. CytoDyn, Inc.
Responsible Party: Sponsor Sponsor
Collaborators: Amarex Clinical Research Amarex Clinical Research
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes Yes
Open or close this module Study Description
Brief Summary: This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS undergoing allogeneic stem-cell transplantation. This is an Open-Label, Single-Arm, Phase II Multicenter Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Reduced Intensity Conditioning (RIC) Allogeneic Stem-Cell Transplantation.
Detailed Description: In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit.

This is an open-label, single-arm, phase II, multicenter study to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD prophylaxis treatment for prevention of acute GVHD in adult patients undergoing RIC allogeneic HCT.

In this study, up to 60 subjects will be enrolled. PRO 140 will be administered as a 525 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for up to 100±7 days. Subjects will return to the clinic for three Follow-up visits at 2 weeks after the last treatment visit, 30 days after the last treatment visit and one year after the first treatment visit.

Open or close this module Conditions
Conditions: Graft vs Host Disease
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Graft Vs Host Disease
Keywords: Allogeneic Stem-Cell Transplantation RIC Allogeneic Stem-Cell Transplantation
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 2Phase 2
Interventional Study Model: Parallel Assignment Single Group Assignment
Number of Arms: 21
Masking: Double (Participant, Care Provider)None (Open Label)
Allocation: RandomizedN/A
Enrollment: 60 [Anticipated] 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PRO 140
30 subjects up to 60 subjects will be enrolled. PRO 140 will be administered as a 525 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for up to 100±7 days. Subjects will return to the clinic for three Follow-up visits at 2 weeks after the last treatment visit, 30 days after the last treatment visit and one year after the first treatment visit.
Drug: PRO 140
Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen.
Other Names:
  • Humanized monoclonal antibody to CCR5
Placebo Comparator: Placebo
30 subjects.
Drug: Placebo
Two 1 mL injections of the Placebo to opposite sides of the abdomen.
Other Names:
  • Placebo Comparator
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Grade II , Grade III or Grade IV acute GVHD
[ Time Frame: 100 Days post treatment ]

Incidence of Grade II , Grade III or Grade IV acute GVHD by Day-100
[ Time Frame: 100 Days post treatment ]

Primary Efficacy Endpoint
Secondary Outcome Measures:
1. Incidence of severe and life-threatening (Grade III and Grade IV) acute GVHD
[ Time Frame: 100 Days post treatment ]

Incidence of severe and life-threatening (Grade III and Grade IV) acute GVHD by Day-100
[ Time Frame: 100 Days post-treatment ]

Secondary Efficacy Endpoint
2. Incidence of organ-specific acute GVHD
[ Time Frame: 100 Days post treatment ]

Incidence of organ-specific acute GVHD by Day-100
[ Time Frame: 100 Days post-treatment ]

Secondary Efficacy Endpoint
3 . Donor engraftment evaluated by T-cell in peripheral blood
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

4 3. Donor engraftment evaluated by myeloid chimerism in peripheral blood
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

Donor engraftment evaluated by T-cell and myeloid chimerism in peripheral blood
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

Secondary Efficacy Endpoint
5 4. Neutrophil count recovery
[ Time Frame: 100 Days post treatment ]

Neutrophil and Platelet count recovery
[ Time Frame: 100 Days post treatment ]

Secondary Efficacy Endpoint
6 5. Changes in ECOG performance score
[ Time Frame: 100 Days post treatment ]

Changes in ECOG performance score
[ Time Frame: 100 Days post treatment ]

Secondary Efficacy Endpoint
7 6. GVHD-free survival (GFS)
[ Time Frame: 100 Days post treatment ]

GVHD-free survival (GFS)
[ Time Frame: 100 Days post treatment ]

Secondary Efficacy Endpoint
7. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

Safety Assessment
8. Frequency of treatment emergent adverse events and serious adverse events
[ Time Frame: 100 Days post treatment ]

Safety Assessment
8 9. Platelet count recovery
[ Time Frame: 100 Days post treatment ]

Hematologic malignancy relapse rate by Day-100
[ Time Frame: 100 Days post treatment ]

Safety Assessment
10. Changes and shifts in laboratory measurements over time
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

Safety Assessment- The laboratory measurements will include Routine CBC, Biochemistry and Urinalysis.

  • Routine CBC includes hemoglobin, hematocrit (HCT), red blood cell (RBC) count, white blood cell (WBC) count, WBC differential count (%), absolute neutrophils count (ANC) and platelets count.
  • Biochemistry profile includes assessment of Hepatic function indicators: total and direct bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, Lactate dehydrogenase (LDH); Renal function indicators: Blood Urea Nitrogen (BUN), creatinine; Electrolytes: sodium, potassium, chloride, calcium and bicarbonate; Other: glucose (random), cholesterol (total)
  • Urinalysis for color, appearance, specific gravity, pH, protein, glucose, occult blood, ketones, RBC, WBC, epithelial cells, bacteria, casts, crystals
11. Changes in Electrocardiogram (ECG) parameters over time
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

Safety Assessment-The following ECG parameters will be evaluated: ventricular rate (beats per minute), PR interval (msec), QRS interval (msec), QT interval (msec), and QTc interval (msec).
Other Outcome Measures:
1 . Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale).
[ Time Frame: 100 Days post treatment ]

2 . Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator-evaluation of injection site reactions.
[ Time Frame: 100 Days post treatment ]

3 . Frequency of treatment emergent adverse events and serious adverse events
[ Time Frame: 100 Days post treatment ]

4 . AML or MDS relapse rate
[ Time Frame: 100 Days post treatment ]

5 . Changes and shifts in laboratory measurements over time
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

6 . Changes in Electrocardiogram (ECG) parameters over time
[ Time Frame: 365 days post-treatment (+/- 14 days) ]

Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 75 Years 65 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  1. Patients diagnosed with AML or MDS per below:
    • Patients with a history of histologically or pathologically confirmed diagnosis of AML and < 5% blasts in the peripheral blood or bone marrow (per bone marrow aspiration and/or biopsy within 6 weeks prior to screening) scheduled to undergo allogeneic stem cell transplantation
    • Patients with a histologically or pathologically confirmed diagnosis of MDS with < 10% blasts in the bone marrow (per bone marrow aspiration and/or biopsy within 6 weeks prior to screening) scheduled to undergo allogeneic stem-cell transplantation
  2. Eastern Cooperative oncology Group (ECOG) performance status score ≤ 2
  3. Patients must have normal organ function as defined below:
    • If undergoing myeloablative allogeneic HCT:
      • Males and females, age ≥18 and ≤ 65 years of age
      • Total bilirubin ≤ 2 mg/dL (except in patients with Gilbert's Syndrome)
      • Aspartate Transaminase (AST) / Alanine Transaminase (ALT) ≤ 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
      • Serum creatinine ≤ 2 mg/dL and creatinine clearance ≥ 60 ml/hr
      • Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
      • Cardiac ejection fraction ≥ 50%. If between 40-49% a cardiology consult is required
      • Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
    • If undergoing non-myeloablative allogeneic HCT:
      • Males and females, age ≥18 and ≤ 75 years of age
      • Total bilirubin ≤ 2 mg/dL (except in patients with Gilbert's Syndrome)
      • AST/ALT ≤ 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
      • Serum creatinine ≤ 2 mg/dL and creatinine clearance ≥ 40 ml/hr
      • DLCO ≥ 40% predicted with no symptomatic pulmonary disease. If DLCO is ≥35% and < 40% and the patient is asymptomatic, a pulmonary consult is required
      • Cardiac ejection fraction > 30%
      • Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
  4. Patients must have a reasonable expectation of ≥ 6 months survival
  5. The donor-recipient Human Leukocyte Antigen (HLA) match criteria required for participation in this protocol are not research subjects in this study and they must meet criteria as National Marrow Donor Program (NMDP) donors. Procedures for selection of donors and stem cell dose will follow FDA Code of Federal Regulations requirements for Blood Products (21 CFR 640) and Human Cellular and Tissue Based Products (21 CFR 1271). The standard institutional practices for stem cell transplants also will be followed. The donors are:
    • HLA-Identical Sibling (6/6): Minimal typing necessary is serologic typing for class I (AB) and molecular typing for class II (DRB1)
    • Matched Unrelated Donor (8/8): Molecular identity at HLA A, B, C and DRB1 by high-resolution typing
    • Matched Related and Unrelated Donor (7/8): high-resolution molecular typing at the following loci is required: HLA A, B, C and DRB1
  6. Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
  7. Patients must understand and voluntarily sign an informed consent form

Exclusion Criteria:

  1. Patients not expected to be available for follow-up for at least 114 days after transplant
  2. Patients who have received prior allogeneic stem cell-transplantation
  3. Patients who receive post-transplant high dose cyclophosphamide
  4. Patients with active central nervous system (CNS) involvement by malignant cells
  5. Patients receiving other investigational drugs for GVHD. Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed
  6. Prior use of any experimental or approved C-C chemokine receptor type 5 (CCR5) modulators including maraviroc and PRO 140
  7. Patients with uncontrolled bacterial, viral or fungal infections including diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of transplant)
  8. Currently active second malignancy other than non-melanoma skin cancers
  9. Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
  10. Patients who are HIV positive
  11. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  12. Subjects on chronic steroid therapy > 5 mg/day within 2 weeks of screening except for inhaled, nasal, or topical steroids
  13. Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Inclusion Criteria

Subjects may be included in the study only if they meet all of the following inclusion criteria:

  1. Patients ≥18 years of age with a hematologic malignancy other than aplastic anemia or primary myelofibrosis, scheduled to undergo RIC allogeneic SCT with a peripheral blood stem cell graft, using Fludarabine/Busulfan (Flu/Bu) conditioning and Tacrolimus/ Methotrexate (Tac/MTX) GVHD prophylaxis. The following diagnoses are included:
    • Acute leukemia - Acute myelogenous leukemia (AML), Acute lymphoblastic leukemia (ALL) or acute bi-phenotypic leukemia.

    Note: Patients should have documentation of complete remission within 6 weeks prior to their transplant. Complete remission is defined as <5% blasts on a bone marrow biopsy and absence of any known extramedullary disease.

    • Chronic myelogenous leukemia (CML) in any stage, but with documentation of <5% blasts on a bone marrow biopsy within 6 weeks prior to transplant.
    • Myelodysplastic syndrome (MDS) of any subtype, but with documentation of <5% blasts on a bone marrow biopsy within 6 weeks prior to transplant.
    • Myeloproliferative disorders other than primary myelofibrosis.
    • Lymphoma - All types of lymphoma are eligible.
    • Chronic lymphocytic leukemia (CLL) and Prolymphocytic leukaemia (PLL).
  2. Patients who meet institutional eligibility criteria for allogeneic SCT:
    • Renal function: Serum creatinine ≤ 2.
    • Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal.
    • Pulmonary: FVC or FEV1 ≥ 40% predicted.
    • Cardiac ejection fraction ≥ 40%.
    • Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI Note: Prior documented echocardiogram and pulmonary function tests within the last 3 months of the Screening Visit is acceptable. If these are not performed within last 3 months, then these tests must be completed within the Screening Phase. In case the test is repeated between the Screening Visit and the First Treatment Visit, the most recent results will be used for the eligibility assessment.
  3. HLA matched sibling or URD at least 7/8 HLA-A, -B, -C and -DRB1 matching by high-resolution molecular typing and will meet eligibility criteria to serve as a peripheral blood stem-cell donor.
  4. Karnofsky scores ≥ 70% at the time of screening.
  5. Capacity to understand and sign the study informed consent form.
  6. Negative pregnancy test. Women of childbearing potential (not having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of > 1 year) must agree to use documented reliable method(s) of contraception. Men should agree to use condoms during the study period.
  7. Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed.

Inclusion Criteria

Subjects may be included in the study only if they meet all of the following inclusion criteria:

  1. Patients ≥18 years of age with a hematologic malignancy other than aplastic anemia or primary myelofibrosis, scheduled to undergo RIC allogeneic SCT with a peripheral blood stem cell graft, using Fludarabine/Busulfan (Flu/Bu) conditioning and Tacrolimus/ Methotrexate (Tac/MTX) GVHD prophylaxis. The following diagnoses are included:
    • Acute leukemia - Acute myelogenous leukemia (AML), Acute lymphoblastic leukemia (ALL) or acute bi-phenotypic leukemia.

    Note: Patients should have documentation of complete remission within 6 weeks prior to their transplant. Complete remission is defined as <5% blasts on a bone marrow biopsy and absence of any known extramedullary disease.

    • Chronic myelogenous leukemia (CML) in any stage, but with documentation of <5% blasts on a bone marrow biopsy within 6 weeks prior to transplant.
    • Myelodysplastic syndrome (MDS) of any subtype, but with documentation of <5% blasts on a bone marrow biopsy within 6 weeks prior to transplant.
    • Myeloproliferative disorders other than primary myelofibrosis.
    • Lymphoma - All types of lymphoma are eligible.
    • Chronic lymphocytic leukemia (CLL) and Prolymphocytic leukaemia (PLL).
  2. Patients who meet institutional eligibility criteria for allogeneic SCT:
    • Renal function: Serum creatinine ≤ 2.
    • Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal.
    • Pulmonary: FVC or FEV1 ≥ 40% predicted.
    • Cardiac ejection fraction ≥ 40%.
    • Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI Note: Prior documented echocardiogram and pulmonary function tests within the last 3 months of the Screening Visit is acceptable. If these are not performed within last 3 months, then these tests must be completed within the Screening Phase. In case the test is repeated between the Screening Visit and the First Treatment Visit, the most recent results will be used for the eligibility assessment.
  3. HLA matched sibling or URD at least 7/8 HLA-A, -B, -C and -DRB1 matching by high-resolution molecular typing and will meet eligibility criteria to serve as a peripheral blood stem-cell donor.
  4. Karnofsky scores ≥ 70% at the time of screening.
  5. Capacity to understand and sign the study informed consent form.
  6. Negative pregnancy test. Women of childbearing potential (not having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of > 1 year) must agree to use documented reliable method(s) of contraception. Men should agree to use condoms during the study period.
  7. Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed.

Exclusion Criteria

Subjects will be excluded from the study if they meet one or more of the following exclusion criteria:

  1. Patients with aplastic anemia or primary myelofibrosis. Patients with marrow fibrosis secondary to MDS, AML or a myeloproliferative disorder other than primary myelofibrosis are eligible.
  2. Patients who are not expected to be available for follow-up in our institution for at least 180 days after the transplant.
  3. Prior allogeneic SCT.
  4. Uncontrolled bacterial, viral or fungal infections.
  5. Prior use of any experimental or approved CCR5 modulators including maraviroc and PRO 140
  6. Patients receiving other investigational drugs for GVHD.
  7. Patients with prior malignancies are excluded unless treated with curative intent and known to be free of disease for at least 2 years.
  8. Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
  9. Patients who are HIV positive
  10. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  11. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Open or close this module Contacts/Locations
Central Contact Person: Anand Balasubramanian, B. Pharm
Telephone: 301-956-2531
Email: anandb@amarexcro.com
Kush Dhody, MBBS, MS
Telephone: 301-956-2536
Email: kushd@amarexcro.com
Locations: United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
[Recruiting]
Miami, Florida, United States, 33136
United States, Illinois
Loyola University Medical Center Cardinal Bernardin Cancer Center
[Recruiting]
Maywood, Illinois, United States, 60153
United States, Michigan
Barbara Ann Karmanos Cancer Institute
[Recruiting]
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
[Recruiting]
Minneapolis, Minnesota, United States, 55409
United States, North Carolina
Wake Forest Baptist Health
[Recruiting]
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pennsylvania
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Transplant Institute Methodist Hospital
[Recruiting]
San Antonio, Texas, United States, 78229
United States, West Virginia
West Virginia University Medicine
[Recruiting]
Morgantown, West Virginia, United States, 26506
Open or close this module IPDSharing
Plan to Share IPD: Undecided Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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