Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03684694
Previous Study | Return to List | Next Study

Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma

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: NCT03684694
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
ADC Therapeutics S.A.

Brief Summary:
The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma Drug: Loncastuximab Tesirine Drug: Ibrutinib Phase 1 Phase 2

Detailed Description:

The Phase 1 portion of the study will cover the dose escalation portion of the study. This will then be followed by the Phase 2 portion of the study, which will treat participants with the dose of loncastuximab tesirine determined in the Phase 1 portion of the study. The ibrutinib dose of 560 mg daily, will remain the same throughout both phases of the study.

A standard 3+3 dose escalation design will be used for the Phase 1 portion of the study. The dose-limiting toxicity (DLT) period will be the 21 days following the first dose of ibrutinib. The dose escalation cohort will receive loncastuximab tesirine for 2 cycles with concurrent ibrutinib (concomitant therapy) and may then continue ibrutinib therapy up to one year.

The Phase 2 portion of the study will involve 3 cohorts:

  • Non-germinal center B-cell diffuse large B-cell lymphoma (Non-GCB DLBCL) cohort
  • Germinal center B-cell diffuse large B-cell lymphoma (GCB DLBCL) cohort
  • Mantle cell lymphoma (MCL) cohort

Each of the cohorts will be treated with the recommended dose of loncastuximab tesirine determined in the Phase 1 portion of the study.

The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 to 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 161 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 14, 2023


Arm Intervention/treatment
Experimental: Phase 1: Dose-Escalation of ADCT-402
A standard 3+3 dose escalation design will be used. The dose-limiting toxicity (DLT) period will be the 21 days following the first dose of ibrutinib. The dose escalation cohort will receive loncastuximab tesirine for Cycle 1 and 2 (3 weeks each) with concurrent ibrutinib (concomitant therapy) daily. Participants may continue to receive treatment up to 1 year after Cycle 1 Day 1 (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered intravenously (IV), as a frozen liquid.
Drug: Loncastuximab Tesirine
Intravenous (IV) infusion.
Other Name: ADCT-402

Drug: Ibrutinib
Oral capsule.

Experimental: Phase 2: MTD or RP2D of ADCT-402 in Non-GCB DLBCL
Participants with non-germinal center B-cell diffuse large B-cell lymphoma (Non-GCB DLBCL) will receive the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of loncastuximab tesirine, as determined in Phase 1, once every 3 weeks for Cycle 1 and 2 and a daily dose of ibrutinib. Participants can continue treatment up to 1 year (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered intravenously (IV), as a lyophilized formulation.
Drug: Loncastuximab Tesirine
Intravenous (IV) infusion.
Other Name: ADCT-402

Drug: Ibrutinib
Oral capsule.

Experimental: Phase 2: MTD or RP2D of ADCT-402 in GCB DLBCL
Participants with germinal center B-cell diffuse large B-cell lymphoma (GCB DLBCL) will receive the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of loncastuximab tesirine, as determined in Phase 1, once every 3 weeks for Cycle 1 and 2 and a daily dose of ibrutinib. Participants can continue treatment up to 1 year (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered intravenously (IV), as a lyophilized formulation.
Drug: Loncastuximab Tesirine
Intravenous (IV) infusion.
Other Name: ADCT-402

Drug: Ibrutinib
Oral capsule.

Experimental: Phase 2: MTD or RP2D of ADCT-402 in MCL
Participants with mantle cell lymphoma (MCL) will receive the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of loncastuximab tesirine, as determined in Phase 1, once every 3 weeks for Cycle 1 and 2 and a daily dose of ibrutinib. Participants can continue treatment up to 1 year (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered intravenously (IV), as a lyophilized formulation.
Drug: Loncastuximab Tesirine
Intravenous (IV) infusion.
Other Name: ADCT-402

Drug: Ibrutinib
Oral capsule.




Primary Outcome Measures :
  1. Phase 1: Number of Adverse Events (AEs) [ Time Frame: Up to 3.5 years ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.

  2. Phase 1: Number of Adverse Events (AEs) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above [ Time Frame: Up to 3.5 years ]

    Adverse events will be graded according to CTCAE v4.0 (or more recent):

    • Grade 3 - Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL).
    • Grade 4 - Life-threatening consequences; urgent intervention indicated.
    • Grade 5 - Death related to adverse event.

    For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.


  3. Phase 1: Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 3.5 years ]
    A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.

  4. Phase 1: Number of Serious Adverse Events (SAEs) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above [ Time Frame: Up to 3.5 years ]

    Adverse events will be graded according to CTCAE v4.0 (or more recent):

    • Grade 3 - Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
    • Grade 4 - Life-threatening consequences; urgent intervention indicated.
    • Grade 5 - Death related to adverse event.

    For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.


  5. Phase 1: Number of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 2 years ]
    Safety and Tolerability (dose escalation only).

  6. Phase 1: Number of Dose Interruptions [ Time Frame: Up to 2 years ]
    Safety and Tolerability.

  7. Phase 1: Number of Dose Reductions [ Time Frame: Up to 2 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  8. Phase 1: Number of Participants who Experience a Clinically Significant Change in Baseline in Laboratory Values [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  9. Phase 1: Number of Participants who Experience a Clinically Significant Change in Baseline in Vital Signs [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  10. Phase 1: Number of Participants who Experience a Clinically Significant Change in Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  11. Phase 1: Number of Participants who Experience a Clinically Significant Change in Baseline in Electrocardiogram (ECG) Results [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  12. Phase 2: Complete Response Rate (CRR) [ Time Frame: Up to 2 years ]
    CRR according to the 2014 Lugano classifications determined by the investigator and/or independent review committee (IRC). CRR defined as the number of participants with a best overall response (BOR) of complete response (CR) in non-germinal center B-cell diffuse large B-cell lymphoma (non-GCB DLBCL) participant cohort only (Phase 2).


Secondary Outcome Measures :
  1. Phase 1: Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    ORR according to the 2014 Lugano classification, defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).

  2. Phase 1 and Phase 2: Duration of Response (DOR) [ Time Frame: Up to 2 years ]
    DOR defined as the time from first tumor response to disease progression or death.

  3. Phase 1 and Phase 2: Relapse-Free Survival (RFS) [ Time Frame: Up to 2 years ]
    Time from the documentation of complete response (CR) to disease progression or death.

  4. Phase 1 and Phase 2: Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]
    Time between start of treatment and the first documentation of progression, or death.

  5. Phase 1 and Phase 2: Overall survival (OS) [ Time Frame: Up to 2 years ]
    Time between the start of treatment and death from any cause.

  6. Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  7. Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  8. Phase 1 and Phase 2: Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  9. Phase 1 and Phase 2: Area Under the Concentration-Time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  10. Phase 1 and Phase 2: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  11. Phase 1 and Phase 2: Clearance (CL) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  12. Phase 1 and Phase 2: Accumulation Index (AI) Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) [ Time Frame: Day 1 (pre-dose, end of infusion and 4 hours post-dose), Day 8 and Day 15 of Cycles 1 and 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
  13. Phase 1 and Phase 2: Number of Participants with Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine [ Time Frame: Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 (Cycle length is 3 weeks) and Day 1 of Cycle 3 onwards (Cycle length is 4 weeks) ]
    Followed by characterization and evaluation of neutralizing capacity as needed.

  14. Phase 2: Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    ORR according to the 2014 Lugano classification, defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).

  15. Phase 2: Complete Response Rate (CRR) in GCB DLBCL, all DLBCL and MCL Participants [ Time Frame: Up to 2 years ]
    CRR according to the 2014 Lugano classifications determined by the investigator and/or independent review committee (IRC). CRR defined as the number of participants with a best overall response (BOR) of complete response (CR) in non-GCB DLBCL, GCB DLBCL, all DLBCL, and MCL participants.

  16. Phase 2: Complete Response Rate (CRR) in Non-GCB DLBCL Participants [ Time Frame: Up to 2 years ]
    CRR according to the 2014 Lugano classifications determined by the investigator and/or independent review committee (IRC). CRR defined as the number of participants with a best overall response (BOR) of complete response (CR) in non-GCB DLBCL participants.

  17. Phase 2: Number of Adverse Events (AEs) [ Time Frame: Up to 3.5 years ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.

  18. Phase 2: Number of Adverse Events (AEs) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above [ Time Frame: Up to 3.5 years ]

    AEs will be graded according to CTCAE v4.0 (or more recent).

    • Grade 3 - Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
    • Grade 4 - Life-threatening consequences; urgent intervention indicated.
    • Grade 5 - Death related to adverse event.

    For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.


  19. Phase 2: Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 3.5 years ]
    A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.

  20. Phase 2: Number of Serious Adverse Events (SAEs) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above [ Time Frame: Up to 3.5 years ]

    Adverse events will be graded according to CTCAE v4.0 (or more recent):

    • Grade 3 - Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
    • Grade 4 - Life-threatening consequences; urgent intervention indicated.
    • Grade 5 - Death related to adverse event.

    For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.


  21. Phase 2: Number of Participants who Experience a Clinically Significant Change in Baseline in Laboratory Values [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  22. Phase 2: Number of Participants who Experience a Clinically Significant Change in Baseline in Vital Signs [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  23. Phase 2: Phase 1: Number of Participants who Experience a Clinically Significant Change in Baseline in Eastern Cooperative Oncology Group (ECOG) [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  24. Phase 2: Number of Participants who Experience a Clinically Significant Change in Baseline in Electrocardiogram (ECG) Results [ Time Frame: Up to 3.5 years ]
    To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the MTD/recommended dose and schedule for future studies.

  25. Phase 2: Functional Scales, Symptoms and Global Health State Scores as measured by The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: Baseline to End of Follow-Up Period (maximum time on follow-up was 2 years) ]
  26. Phase 2: Lymphoma Subscale (LymS) of Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Scores [ Time Frame: Baseline to End of Follow-Up Period (maximum time on follow-up was 2 years) ]
  27. Phase 2: EuroQoL 5-dimension 5-level (EQ-5D-5L) [ Time Frame: Baseline to End of Follow-Up Period (maximum time on follow-up was 2 years) ]
    Change from Baseline in Visual Analog Scale scores (VAS) at each scheduled assessment. Individual dimension responses will be summarized at each scheduled assessment with frequency counts and percentage of participants.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participant aged 18 years or older
  2. Pathologic diagnosis of DLBCL or MCL
  3. Participants with DLBCL must have relapsed or refractory disease and have failed or been intolerant to available standard therapy
  4. Participants with MCL must have relapsed or refractory disease and have received at least one prior line of therapy
  5. Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy
  6. Measurable disease as defined by the 2014 Lugano Classification
  7. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available)
  8. ECOG performance status 0 to 2
  9. Screening laboratory values within the following parameters:

    1. Absolute neutrophil count (ANC) ≥1.0 × 103/µL (off growth factors at least 72 hours)
    2. Platelet count ≥75 × 103/µL without transfusion in the past 7 days
    3. Hemoglobin ≥8 g/dL (4.96 mmol/L), transfusion allowed
    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the ULN
    5. Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)
    6. Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft and Gault equation
  10. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drugs on C1D1 for women of childbearing potential
  11. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 20 weeks after the participant receives his last dose of study therapy

Exclusion Criteria:

  1. Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD19 antibody
  2. Known history of hypersensitivity to ibrutinib
  3. Previous therapy with ibrutinib or other BTK inhibitors
  4. Previous therapy with loncastuximab tesirine
  5. Requires treatment or prophylaxis with a moderate or strong cytochrome P450 (CYP) 3A inhibitor
  6. Allogenic or autologous transplant within 60 days prior to start of study drugs (C1D1)
  7. Active graft-versus-host disease
  8. Post-transplantation lymphoproliferative disorder
  9. Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
  10. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV).
  11. History of Stevens-Johnson syndrome or toxic epidermal necrolysis
  12. Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease
  13. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
  14. Breastfeeding or pregnant
  15. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 millimeters of mercury (mmHg) repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes mellitus, or severe chronic pulmonary disease, or tuberculosis infection (tuberculosis screening based on local standards).
  16. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drugs (C1D1), except shorter if approved by the Sponsor
  17. Use of any other experimental medication within 14 days prior to start of study drugs (C1D1)
  18. Planned live vaccine administration after starting study drugs (C1D1)
  19. Any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
  20. Inherited or acquired bleeding disorders
  21. Ongoing anticoagulation treatment, except for low-dose heparinisation or equivalent
  22. Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening
  23. Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block)
  24. Active second primary malignancy other than non-melanoma skin cancers, non metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree, and document should not be exclusionary
  25. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the participant inappropriate for study participation or put the participant at risk

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): NCT03684694


Contacts
Layout table for location contacts
Contact: ADC Therapeutics 954-903-7994 clinical.trials@adctherapeutics.com

Locations
Layout table for location information
United States, Georgia
Georgia Cancer Center at Augusta University Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Locke Bryan         
United States, Kentucky
Norton Cancer Institute, St. Matthews Campus Recruiting
Louisville, Kentucky, United States, 40207
Contact: Joseph J Maly         
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Nina Wagner-Johnston         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tycel Phillips         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Murali Janikiram         
Belgium
CHU UCL Namur (Site Godinne) Recruiting
Yvoir, Belgium, 5530
Contact: Julien Depaus         
France
Centre Hospitalier Universitaire de Rennes Hôpital Pontchailou Recruiting
Bretagne, France, 35033
Contact: Thierry Lamy de la Chapelle         
Hôpital Saint-Eloi Recruiting
Montpellier, France, 34295
Principal Investigator: Giullaume Cartron         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Principal Investigator: Gille Salles         
Centre Hospitalier Universitaire De Poitier - Hopital De La Miletrie - Hopital Jean Bernard Recruiting
Poitiers, France, 86021
Principal Investigator: Vincent Delwail         
Italy
IRCCS istituto Clinico Humanitas U.O. di Oncologia ed Ematologia Recruiting
Via Manzoni, Rozzano, Italy, 20089
Principal Investigator: Carmelo Carlo-Stella         
Azienda Ospedaliera Pap Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Principal Investigator: Alessandro Rambaldi         
Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy, 40138
Contact: Pier Luigi Zinzani         
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Recruiting
Brescia, Italy, 25123
Principal Investigator: Alessandra Tucci         
Istituto Scientifico Rmagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola FC, Italy, 47014
Contact: Gerardo Musuraca         
Azienda Unita Sanitaria Locale de Ravenna Recruiting
Ravenna, Italy, 48100
Contact: Monica Tani         
Sponsors and Collaborators
ADC Therapeutics S.A.
Layout table for additonal information
Responsible Party: ADC Therapeutics S.A.
ClinicalTrials.gov Identifier: NCT03684694    
Other Study ID Numbers: ADCT-402-103
2018-002625-38 ( EudraCT Number )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ADC Therapeutics S.A.:
Loncastuximab Tesirine in Combination with Ibrutinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin