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Trial record 2 of 11 for:    loncastuximab

Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT04998669
Recruitment Status : Not yet recruiting
First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
ADC Therapeutics S.A.
Information provided by (Responsible Party):
Juan P. Alderuccio, MD, University of Miami

Tracking Information
First Submitted Date  ICMJE August 7, 2021
First Posted Date  ICMJE August 10, 2021
Last Update Posted Date August 10, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2021)
Number of participants achieving Complete Response (CR) [ Time Frame: 12 weeks ]
Complete Response rate will be reported as the number of participants achieving complete response (CR) to study therapy. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria by week 12 of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2021)
  • Number of participants achieving CR or PR [ Time Frame: Week 12 ]
    Overall response rate (ORR) will be reported as the number of participants achieving complete response (CR) or partial response (PR) by the end of the induction phase, week 12. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria.
  • Incidence of Treatment-Related Adverse Events [ Time Frame: Up to 13 months ]
    Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
  • Progression-free Survival (PFS) [ Time Frame: Up to 3 years ]
    Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting treatment (Cycle 1 Day 1) until disease progression or death (whichever occur first).
  • Overall Survival (OS) [ Time Frame: Up to 3 years ]
    Overall survival (OS) will be defined as the elapsed time from the date of starting treatment (Cycle 1 Day 1) until death.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
Official Title  ICMJE Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
Brief Summary The purpose of this research is to see if Loncastuximab Tesirine in combination with Rituximab will result in higher complete response rate when given to treat follicular lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • Drug: Loncastuximab tesirine

    Induction Phase (Cycles 1 through 4):

    • 150 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 1 and 2.
    • 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 3 and 4.

    Maintenance Phase 1 (Cycle 5): For participants achieving CR or PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines). on Day 1 on Week 1, 4, 7 of a 8-week cycle.

    Maintenance Phase 2 (Cycle 6 & 7): For participants achieving PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Day 1 on Week 1, 4, 7 of a 8-week cycle.

    Other Name: ADCT-402
  • Drug: Rituximab

    Induction Phase (Cycles 1 through 4): 375 mg/m2 rituximab on days 1, 8, 15 of cycle 1 and day 1 of cycle 2 via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase during Cycles 1 and 2, per discretion of treating physician. Rituximab will not be administered during Cycles 3 and 4.

    Maintenance Phase 1 (Cycle 5): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 7 or 8 of a 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician.

    Maintenance Phase 2 (Cycles 6 and 7): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 7 or 8 of each 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician.

    Other Name: Rituxan
Study Arms  ICMJE Experimental: Loncastuximab tesirine + Rituximab

During the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2.

Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment.

Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks:

  • Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7.
  • Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7.
  • Participants achieving SD or PD will be taken off treatment.
Interventions:
  • Drug: Loncastuximab tesirine
  • Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2021)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2027
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Patients must have histologic confirmation of Cluster of Differentiation (CD)19 and CD20-positive Follicular Lymphoma (FL) (grade 1, 2 and 3A)
  3. Patients with relapsed or refractory FL previously treated with ≥1 line of systemic therapy having ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for therapy, Progression of Diseases within 24 months (POD24), or second relapse.
  4. Baseline FDG-PET/CT scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification.
  5. Patient should have ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for treatment initiation).

    • Involvement of ≥3 nodal sites, each with diameter of ≥3 cm
    • Any nodal or extranodal tumor mass with a diameter of ≥7 cm
    • B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss > 10% within the prior 6 months).
    • Risk of local compressive symptoms that may result in organ compromise
    • Splenomegaly or splenic lesion without splenomegaly
    • Leukopenia (leukocytes < 1000/mm3)
    • Leukemia (> 5.000 lymphoma cells/mm3)
    • Bone lesions detected on FDG-PET/CT; or
  6. Progression or relapsed within 24 months after FL diagnosis in patients previously treated with ≥1 line of systemic therapy; or
  7. Second FL relapse/progression after ≥1 line of systemic therapy.
  8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  9. Life expectancy of greater than 6 weeks.
  10. Patients must have normal organ and marrow function as defined below,

    • Absolute neutrophil count ≥1000/mm3 (unless due to lymphoma involvement of the bone marrow or spleen).
    • Platelets ≥100,000/mm3.
    • Hemoglobin ≥ 10 g/dL or ≥8 g/dL in case of bone marrow involvement by lymphoma.
    • Total bilirubin < 1.5 x within normal institutional limits (unless due to lymphoma involvement of liver or a known history of Gilbert's disease).
    • Gamma-Glutamyl Transpeptidase (GGT)/Aspartate Aminotransferase (AST)/(SGOT)/Alanine Aminotransferase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal.
    • Creatinine within normal institutional limits, or creatinine clearance ≥40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (unless due to lymphoma).

Exclusion Criteria:

  1. FL grade 3B or transformed FL.
  2. Patients with standardized uptake value (SUV) ≥ 14 on FDG-PET/CT and inaccessible biopsy site.
  3. > 2 lines of systemic immunochemotherapy for treatment of FL.
  4. Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath.
  5. Patients receiving any other investigational agents.
  6. Patients with known central nervous system involvement of lymphoma.
  7. Uncontrolled intercurrent illness such as: history of Myocardial Infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (>10 mg daily prednisone equivalent).
  8. Breastfeeding or pregnant women.
  9. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody will need a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.) Hepatitis C antibody positive patients are eligible if PCR is negative. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis.
  10. Human immunodeficiency virus (HIV) infection.
  11. Patients with impaired decision-making capacity.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juan P Alderuccio, MD 305-243-5995 jalderuccio@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04998669
Other Study ID Numbers  ICMJE 20201130
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Juan P. Alderuccio, MD, University of Miami
Study Sponsor  ICMJE Juan P. Alderuccio, MD
Collaborators  ICMJE ADC Therapeutics S.A.
Investigators  ICMJE
Principal Investigator: Juan P Alderuccio, MD University of Miami
PRS Account University of Miami
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP