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Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas

Primary Purpose

Lymphoma, Non-Hodgkin's, Adult, Lymphoma, Hodgkin's, Adult

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FE 203799
Sponsored by
GlyPharma Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma, Non-Hodgkin's, Adult focused on measuring gastrointestinal mucositis, myeloablative chemotherapy, autologous transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult male and non-pregnant or lactating female patients diagnosed with Hodgkin's lymphoma (HL) or non- Hodgkin's lymphoma (NHL; T- or B-cell variants) based on histological or cytological evidence.
  2. Patients are eligible to receive myeloablative chemotherapy as per center eligibility criteria, followed by AHSCT.
  3. Patients between 18 years and 65 years of age with a Hematopoietic Cell Transplant- Co-morbidity Index (HCT-CI) ≤5. Patients between 65 years and 70 years will be eligible if their HCT-CI score is ≤3.
  4. Patients, or their legal representatives, must have the ability to read, understand and provide written informed consent prior to the initiation of any study related procedures.
  5. Patients must have chemo-sensitive disease and be in partial or complete remission following the most recent anti-neoplastic therapy regimen, according to the Lugano revision of the International Working Group (IWG) response criteria [1].
  6. Patients must have available a cryopreserved autologous hematopoietic stem cell graft containing ≥ 2.0 x 106 cryopreserved CD34+ cells/kg.
  7. Patients must have a Karnofsky score ≥ 70%.
  8. Patients must have adequate hepatic function as evidenced by bilirubin ≤ upper limit of normal (ULN), unless felt to be related to Gilbert's syndrome or hemolysis; patients must also have AST and ALT ≤ 1.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
  9. Patients must have an estimated or measured creatinine clearance ≥ 30 ml/min/1.73 m2 by the Cockcroft-Gault equation.
  10. Patients must have left ventricular ejection fraction ≥ 50%.
  11. Patients must have forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusing capacity corrected for hemoglobin (DLCOc) ≥ 50% of predicted.
  12. Patients must have recovered from the effects of any prior chemotherapy, radiotherapy or surgery; for patients who have been on monoclonal antibody therapy, at least one half-life or 4 weeks (whichever is longer) should have elapsed prior to the first scheduled day of dosing with FE 203799.
  13. A female recipient of childbearing potential must meet the following criteria:

    1. Participant has a negative pregnancy test at Screening.
    2. Participant agrees to use one of the accepted contraceptive regimens from at least 14 days prior to the first administration of the Study Drug, during the study and for at least 90 days after the last dose of the Study Drug. An acceptable method of contraception includes one of the following:

      • Abstinence from heterosexual intercourse
      • Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
      • Intrauterine device (with or without hormones)
      • Diaphragm with spermicidal gel
      • Condom with spermicide gel
  14. A male patient, with sexual partners who are pregnant, possibly pregnant, or who could become pregnant, agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study and until at least 3 months after the last drug administration. An acceptable method of contraception includes one of the following:

    • Abstinence from heterosexual intercourse
    • Condom with spermicide

Exclusion Criteria:

  1. Patient is unable or unwilling to give informed consent.
  2. Patients who are unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
  3. Patients with known hypersensitivity to FE 203799, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions to any drugs.
  4. Patients with an active infection or with a fever ≥38.5oC within 3 days of the first scheduled day of dosing.
  5. Patients who had an autologous stem cell transplant within 24 months.
  6. Patients who had an available cryopreserved autologous graft with a CD34+ cell count of < 2 x 106/kg.
  7. Patients undergoing AHSCT for conditions other than lymphoma.
  8. Presence of a malignancy other than the one for which the transplant is being performed (except for baso-cellular skin carcinoma).
  9. Patients who are receiving investigational therapies or who have been treated with investigational therapies or investigational devices within 30 days prior to the first scheduled day of dosing with FE 203799.
  10. Patients with cardiovascular congestive heart failure, unstable angina pectoris, cardiac arrhythmias requiring a pacemaker; myocardial infarction within the past six months; stroke within the past 6 months; or uncontrolled hypertension.
  11. Patients with mean QTcF values of >450 msec (in males) or >470 msec (in females) following ECGs conducted in triplicate 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes, including patients who are already on medication known to cause prolonged QT intervals on ECG.
  12. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec) on the screening ECG or other clinically significant ECG abnormalities.
  13. Patients with history or presence of GI tract cancer, polyps, ulcerative colitis, Crohn's disease, coeliac disease, tropical sprue, etc.
  14. Presence of active pancreatic disease.
  15. Presence of active liver disease (i.e. cirrhosis; bilirubin > ULN; transaminases > 1.5 x ULN; alkaline phosphatase > 2.5 x ULN).
  16. Presence of autoimmune disease.
  17. Patients with suicidal tendency or clinically relevant psychiatric diseases or substance abuse.
  18. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HbsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests.
  19. Any abnormal condition or laboratory result that is considered by the PI capable of altering patient's condition or study outcome.
  20. Patients who are pregnant or lactating.
  21. Patients who are unwilling to use appropriate contraception.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort A: 5 mg (FE 203799/Placebo)

    Cohort B: 10 mg (FE 203799/Placebo)

    Cohort C: 25 mg (FE 203799/Placebo)

    Arm Description

    Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation

    Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation

    Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation

    Outcomes

    Primary Outcome Measures

    Incidence of treatment-emergent adverse events
    Adverse events as assessed by CTCAE v4.03

    Secondary Outcome Measures

    Maximum observed plasma concentration (Cmax) of FE 203799
    Cmax in ng/ml
    Cumulative area under the plasma concentration (AUC) time curve from 0-168 hours of FE 203799
    AUC0-168 in ng*hr/ml
    Cumulative area under the plasma concentration (AUC) from time zero to infinity of FE 203799
    AUC0-inf in ng*hr/ml
    Terminal elimination half-life (T1/2) of FE 203799
    T1/2 in hours
    Apparent total body clearance (CL) of the drug from plasma of FE 203799
    CL in ml/hr
    Apparent volume of distribution (Vz) of FE 203799 during terminal phase
    Vz in ml
    Biomarker assessment for gut healing
    Plasma concentration of citrulline (ng/ml)
    Biomarker assessment for gut inflammation
    Plasma concentration of C-Reactive Protein (ng/ml)
    Assessment of infection - Incidence and duration of fever
    Body temperature ≥38.2oC
    Assessment of infection - Incidence and duration of neutropenic fever
    Development of fever when absolute neutrophil count (ANC) ≤ 0.5 x 109 and body temperature ≥ 38.2 ◦C for two consecutive values over a 30 minute period of time; or ANC < 0.5 x 109 and body temperature ≥ 38.5◦C at any single timepoint
    Incidence of microbiologically detected infection
    Blood cultures once daily
    Assessment of gastrointestinal mucositis and related clinical symptoms
    Grading as by the CTCAE v4.03
    Assessment of gastrointestinal mucositis by video-capsule endoscopy
    Gastrointestinal damage assessed by the Lewis Score; this is evaluation of villous edema, ulcers and stenosis graded collectively; Normal < 135, Mild 135-790, Moderate - severe ≥790
    Assessment of nutrients absorption
    Body weight (kg)
    Assessment of nutrients absorption
    Assessment of duration of parenteral nutrition (L)
    Assessment of nutrients absorption
    Assessment of caloric intake (calories)
    Microbiome composition
    Determination of microbial populations by genomic analysis (relative abundance of taxonomic levels)
    Time to neutrophil and platelet engraftment
    Hematological analysis
    Assessment of quality of life
    Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire

    Full Information

    First Posted
    November 13, 2017
    Last Updated
    October 22, 2020
    Sponsor
    GlyPharma Therapeutics
    Collaborators
    VectivBio AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03417765
    Brief Title
    Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas
    Official Title
    Double-blind, Placebo Controlled, Ascending Dose, Randomized Phase 1B/2A Study, Investigating Safety, Tolerability, PK/PD of FE 203799 in Lymphoma Patients, Undergoing Myeloablative Chemotherapy Before Autologous Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    March 31, 2019 (Anticipated)
    Study Completion Date
    March 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlyPharma Therapeutics
    Collaborators
    VectivBio AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut function. Damage of the epithelium (i.e. by chemotherapy) results in significant cellular and molecular alterations that ultimately lead to intestinal dysfunction/failure. This intestinal dysfunction manifests as several pathological processes, such as inability to absorb nutrients, intestinal inflammation, immune system dysregulation, and disequilibrium of normal intestinal microbiota leading to increased risk of infection due to bacterial translocation and septicaemia. Gastrointestinal (GI) mucositis is a well-known, frequent and debilitating side effect of most anticancer regimens with a very high incidence in hemato-oncology. The most common symptoms are nausea, vomiting, weight loss, abdominal cramps and pain, diarrhea, and electrolyte imbalance. Patients may also experience ulceration/bleeding and injury of the lining of the entire gastrointestinal tract from the esophagus to the colon. Currently no therapy is available for the prevention or treatment of GI intestinal injury. Treatment of related symptoms is limited to supportive measures to decrease diarrhea and to preventive antibiotic therapy. The GLP-2 analogue, FE 203799, has a favorable pharmacology profile for clinical development in the intended therapeutic indication of myeloablative chemotherapy-induced GI damage. The data collected from animal studies has shown that FE 203799 stimulates the proliferation of the intestinal epithelium and protects the GI mucosa from chemotherapy-induced injury. Hence, the primary pharmacologic activity of FE 203799 would promote a healthy GI microenvironment, thus preventing intestinal dysfunction and related complications. PURPOSE: Prevention by FE 203799 of chemotherapy-induced intestinal damage and related complications in patients with lymphoma receiving Melphalan based (BEAM) myeloablative conditioning regimen followed by hematopoietic stem cell transplantation.
    Detailed Description
    OUTLINE: Multi-center, double-blind, placebo-controlled, ascending dose, randomized Phase IB/2A study to assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile of s.c. FE 203799 in patients diagnosed with Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL) undergoing Melphalan-based myeloablative chemotherapy (BEAM) followed by autologous human stem cell transplantation (AHSCT). In addition, the impact of FE 203799 on post-transplantation outcomes will be assessed. These outcomes include assessment of intestinal mucosal injury and inflammation, incidence of infection and bacteremia, development of neutropenic fever, assessment of nutritional parameters, modification of the composition of the gut microbiome, recovery of the hematopoietic system and quality of life. More specifically: - PRIMARY OBJECTIVE: Safety and tolerability of s.c. FE 203799 - SECONDARY OBJECTIVES: Determine the PK profile and dose-effect of s.c. FE 203799. Determine the PD profile of s.c. FE 203799, based on the plasma concentration of citrulline (indicative of intestinal mass) and of C-Reactive Protein (CRP) (indicative of inflammation). Determine the dose/response (PK/PD) relationship of s.c. FE 203799. Determine the impact of treatment with s.c. FE 203799 on the incidence and severity of chemotherapy induced intestinal toxicity, as assessed by both symptomatic and visual manifestations of mucosal injury and associated complications. Assess the effect of s.c. FE 203799 on the prevention of development of neutropenic fever and bacteremia. METHODOLOGY - STUDY DESIGN The patient population will consist of adult female and male Hodgkin's or non-Hodgkin's lymphomas patients who are eligible to receive BEAM as conditioning regimen followed by autologous type AHSCT using peripheral blood or bone marrow stem cells. At the time of enrollment, patients must be in complete or partial remission following their most recent anti-neoplastic therapy. Patients are required to have available a cryopreserved autologous stem cell graft with a minimum CD34+ cell dose of 2 x 106 cells/kg. Three ascending dose levels of FE 203799 will be investigated (5 mg, 10 mg and 25 mg), with 16 patients required per dose cohort. Patients in each dose cohort will be randomized to FE 203799 vs. Placebo in a 3:1 ratio (12 patients per dose level receiving FE 203799, and 4 patients receiving Placebo), in a double-blind manner. Randomization will occur during the screening period upon confirmation that the patient has met all inclusion and exclusion criteria. A total of 48 subjects, completing the study, is targeted for enrollment. The study will be conducted in approximately 10 clinical centers. Eligibility will be determined at the Screening Visit following signature of the informed consent form (ICF). The inclusion and exclusion criteria will be used to qualify the patient for study entry. Within each cohort, patients will receive 4 doses of the Study Drug (FE 203799 or Placebo). As such, patients will be required to be dosed with the Study Drug the day prior the initiation of the BEAM regimen and subsequently on a weekly basis for 3 consecutive weeks after initiation of chemotherapy. Assessments performed prior to the first dose, will be considered as Baseline. Serial blood samples for determination of the plasma concentration of FE 20799/Placebo, as well as the plasma levels of citrulline and C-Reactive protein (CRP) will be obtained at pre-specified time points. During the Study, patients will be hospitalized during the duration of the conditioning chemotherapy to approximately 3 or 4 weeks post-transplantation depending on their recovery and physical condition. All patients who received at least one treatment, will be required to return to the hospital for the End of Study Visit (Day 30 ±5 post-transplantation) and for two additional follow-up safety visits on Days 45 (±5) and 100 (±5) post-transplantation. A Data Monitoring Committee (DMC) will convene at pre-determined timepoints, or as needed. The grading of adverse events (AEs) will be based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) (Grade 1 to 5).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Non-Hodgkin's, Adult, Lymphoma, Hodgkin's, Adult
    Keywords
    gastrointestinal mucositis, myeloablative chemotherapy, autologous transplantation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    Placebo-control, ascending dose
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double-blind
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort A: 5 mg (FE 203799/Placebo)
    Arm Type
    Experimental
    Arm Description
    Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation
    Arm Title
    Cohort B: 10 mg (FE 203799/Placebo)
    Arm Type
    Experimental
    Arm Description
    Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation
    Arm Title
    Cohort C: 25 mg (FE 203799/Placebo)
    Arm Type
    Experimental
    Arm Description
    Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation
    Intervention Type
    Drug
    Intervention Name(s)
    FE 203799
    Intervention Description
    GLP-2 analogue, once weekly, subcutaneous administration
    Primary Outcome Measure Information:
    Title
    Incidence of treatment-emergent adverse events
    Description
    Adverse events as assessed by CTCAE v4.03
    Time Frame
    Day -8 to Day 100
    Secondary Outcome Measure Information:
    Title
    Maximum observed plasma concentration (Cmax) of FE 203799
    Description
    Cmax in ng/ml
    Time Frame
    Day -8 to Day 13
    Title
    Cumulative area under the plasma concentration (AUC) time curve from 0-168 hours of FE 203799
    Description
    AUC0-168 in ng*hr/ml
    Time Frame
    Day -8 to Day 13
    Title
    Cumulative area under the plasma concentration (AUC) from time zero to infinity of FE 203799
    Description
    AUC0-inf in ng*hr/ml
    Time Frame
    Day -8 to Day 13
    Title
    Terminal elimination half-life (T1/2) of FE 203799
    Description
    T1/2 in hours
    Time Frame
    Day -8 to Day 13
    Title
    Apparent total body clearance (CL) of the drug from plasma of FE 203799
    Description
    CL in ml/hr
    Time Frame
    Day -8 to Day 13
    Title
    Apparent volume of distribution (Vz) of FE 203799 during terminal phase
    Description
    Vz in ml
    Time Frame
    Day -8 to Day 13
    Title
    Biomarker assessment for gut healing
    Description
    Plasma concentration of citrulline (ng/ml)
    Time Frame
    Day -8 to Day -1, Day 1 to Day 14 and Day 30
    Title
    Biomarker assessment for gut inflammation
    Description
    Plasma concentration of C-Reactive Protein (ng/ml)
    Time Frame
    Day -8 to Day -1, Day 1 to Day 14 and Day 30
    Title
    Assessment of infection - Incidence and duration of fever
    Description
    Body temperature ≥38.2oC
    Time Frame
    Day -8 to Day 20 and Day 30
    Title
    Assessment of infection - Incidence and duration of neutropenic fever
    Description
    Development of fever when absolute neutrophil count (ANC) ≤ 0.5 x 109 and body temperature ≥ 38.2 ◦C for two consecutive values over a 30 minute period of time; or ANC < 0.5 x 109 and body temperature ≥ 38.5◦C at any single timepoint
    Time Frame
    Day -8 to Day 20 and Day 30
    Title
    Incidence of microbiologically detected infection
    Description
    Blood cultures once daily
    Time Frame
    Day 5 to Day 15
    Title
    Assessment of gastrointestinal mucositis and related clinical symptoms
    Description
    Grading as by the CTCAE v4.03
    Time Frame
    Day -8 to Day 20 and Day 30
    Title
    Assessment of gastrointestinal mucositis by video-capsule endoscopy
    Description
    Gastrointestinal damage assessed by the Lewis Score; this is evaluation of villous edema, ulcers and stenosis graded collectively; Normal < 135, Mild 135-790, Moderate - severe ≥790
    Time Frame
    Day -8, Day 6 and Day 20
    Title
    Assessment of nutrients absorption
    Description
    Body weight (kg)
    Time Frame
    Days -8, -1, 6, 13 and 30
    Title
    Assessment of nutrients absorption
    Description
    Assessment of duration of parenteral nutrition (L)
    Time Frame
    Days -8, 0, 3, 6, 9, 12, 15, 18
    Title
    Assessment of nutrients absorption
    Description
    Assessment of caloric intake (calories)
    Time Frame
    Days -8, 0, 3, 6, 9, 12, 15, 18
    Title
    Microbiome composition
    Description
    Determination of microbial populations by genomic analysis (relative abundance of taxonomic levels)
    Time Frame
    Once a week over 4 weeks
    Title
    Time to neutrophil and platelet engraftment
    Description
    Hematological analysis
    Time Frame
    Day-8 and then on Days -2, 5, 12 and 30
    Title
    Assessment of quality of life
    Description
    Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire
    Time Frame
    Days -8, -1, 6, 13 and 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult male and non-pregnant or lactating female patients diagnosed with Hodgkin's lymphoma (HL) or non- Hodgkin's lymphoma (NHL; T- or B-cell variants) based on histological or cytological evidence. Patients are eligible to receive myeloablative chemotherapy as per center eligibility criteria, followed by AHSCT. Patients between 18 years and 65 years of age with a Hematopoietic Cell Transplant- Co-morbidity Index (HCT-CI) ≤5. Patients between 65 years and 70 years will be eligible if their HCT-CI score is ≤3. Patients, or their legal representatives, must have the ability to read, understand and provide written informed consent prior to the initiation of any study related procedures. Patients must have chemo-sensitive disease and be in partial or complete remission following the most recent anti-neoplastic therapy regimen, according to the Lugano revision of the International Working Group (IWG) response criteria [1]. Patients must have available a cryopreserved autologous hematopoietic stem cell graft containing ≥ 2.0 x 106 cryopreserved CD34+ cells/kg. Patients must have a Karnofsky score ≥ 70%. Patients must have adequate hepatic function as evidenced by bilirubin ≤ upper limit of normal (ULN), unless felt to be related to Gilbert's syndrome or hemolysis; patients must also have AST and ALT ≤ 1.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN. Patients must have an estimated or measured creatinine clearance ≥ 30 ml/min/1.73 m2 by the Cockcroft-Gault equation. Patients must have left ventricular ejection fraction ≥ 50%. Patients must have forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusing capacity corrected for hemoglobin (DLCOc) ≥ 50% of predicted. Patients must have recovered from the effects of any prior chemotherapy, radiotherapy or surgery; for patients who have been on monoclonal antibody therapy, at least one half-life or 4 weeks (whichever is longer) should have elapsed prior to the first scheduled day of dosing with FE 203799. A female recipient of childbearing potential must meet the following criteria: Participant has a negative pregnancy test at Screening. Participant agrees to use one of the accepted contraceptive regimens from at least 14 days prior to the first administration of the Study Drug, during the study and for at least 90 days after the last dose of the Study Drug. An acceptable method of contraception includes one of the following: Abstinence from heterosexual intercourse Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) Intrauterine device (with or without hormones) Diaphragm with spermicidal gel Condom with spermicide gel A male patient, with sexual partners who are pregnant, possibly pregnant, or who could become pregnant, agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study and until at least 3 months after the last drug administration. An acceptable method of contraception includes one of the following: Abstinence from heterosexual intercourse Condom with spermicide Exclusion Criteria: Patient is unable or unwilling to give informed consent. Patients who are unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests. Patients with known hypersensitivity to FE 203799, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions to any drugs. Patients with an active infection or with a fever ≥38.5oC within 3 days of the first scheduled day of dosing. Patients who had an autologous stem cell transplant within 24 months. Patients who had an available cryopreserved autologous graft with a CD34+ cell count of < 2 x 106/kg. Patients undergoing AHSCT for conditions other than lymphoma. Presence of a malignancy other than the one for which the transplant is being performed (except for baso-cellular skin carcinoma). Patients who are receiving investigational therapies or who have been treated with investigational therapies or investigational devices within 30 days prior to the first scheduled day of dosing with FE 203799. Patients with cardiovascular congestive heart failure, unstable angina pectoris, cardiac arrhythmias requiring a pacemaker; myocardial infarction within the past six months; stroke within the past 6 months; or uncontrolled hypertension. Patients with mean QTcF values of >450 msec (in males) or >470 msec (in females) following ECGs conducted in triplicate 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes, including patients who are already on medication known to cause prolonged QT intervals on ECG. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec) on the screening ECG or other clinically significant ECG abnormalities. Patients with history or presence of GI tract cancer, polyps, ulcerative colitis, Crohn's disease, coeliac disease, tropical sprue, etc. Presence of active pancreatic disease. Presence of active liver disease (i.e. cirrhosis; bilirubin > ULN; transaminases > 1.5 x ULN; alkaline phosphatase > 2.5 x ULN). Presence of autoimmune disease. Patients with suicidal tendency or clinically relevant psychiatric diseases or substance abuse. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HbsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests. Any abnormal condition or laboratory result that is considered by the PI capable of altering patient's condition or study outcome. Patients who are pregnant or lactating. Patients who are unwilling to use appropriate contraception.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Silvy Lachance, MD, PhD
    Organizational Affiliation
    Hôpital Maisonneuve Rosemont, Montréal, QC, Canada
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Micheline St-John, BSc
    Organizational Affiliation
    JSS Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas

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