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Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease. (FIL_BVHD01)

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ClinicalTrials.gov Identifier: NCT02227433
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Tracking Information
First Submitted Date  ICMJE August 11, 2014
First Posted Date  ICMJE August 28, 2014
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE February 4, 2013
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2014)
Antitumor Efficacy [ Time Frame: two years ]
• The antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02227433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2014)
  • Survival, safety and tolerability [ Time Frame: two years ]
    • The duration of tumor control, including duration of response and progression-free survival
  • Survival [ Time Frame: Two years ]
    • The survival
  • Safety and tolerability of Brentuximab Vedotin [ Time Frame: Two years ]
    • The safety and tolerability of BV
  • Disease related symptoms [ Time Frame: Two years ]
    Additional: • The disease-related symptoms
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 Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease.
Official Title  ICMJE A Phase II Study of Brentuximab Vedotin (BV) in the Treatment of Elderly Hodgkin Lymphoma (HL) Patients at First Relapse or With Primary Refractory Disease.
Brief Summary

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL.

BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007).

Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.

Study Objectives

Primary:

• To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).

Secondary:

  • To assess duration of tumor control, including duration of response and progression-free survival
  • To assess survival
  • To assess the safety and tolerability of BV

Additional:

• To assess disease-related symptoms Study Population Eligible patients are those with first relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, kidney, and liver function. Eligible patients must not previously have been treated with BV, patients must not have congestive heart failure, known cerebral/meningeal disease, or any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to first study dose.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE Drug: Brentuximab Vedotin
Other Name: SGN
Study Arms  ICMJE Experimental: brentuximab vedotin (BV)
Intervention: Drug: Brentuximab Vedotin
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 27, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed CD30-positive disease
  2. Elderly patients at first relapse or with primary refractory HL (i.e. patients who have previously received only 1 line of treatment.
  3. Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents greater than 5 half-lives of the last dose of that prior treatment prior to the first dose of BV and must have fully recovered from the acute toxic effects prior to entering this study.
  4. Age greater than or equal to 60 years.
  5. Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
  6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. The following required baseline laboratory data: absolute neutrophil count (ANC) ≥1500/µL, unless known marrow involvement due to disease, platelets ≥75,000/µL, unless known marrow involvement due to disease, bilirubin ≤1.5X upper limit of normal (ULN) or ≤3X ULN for patients with Gilbert's disease, serum creatinine ≤1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN.
  8. Females of childbearing potential must have a negative serum or urine β-hCG pregnancy test result prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
  9. Females of childbearing potential must agree to use two effective contraceptive methods during the study and for 6 months following the last dose of study drug or agree to completely abstain from heterosexual intercourse.
  10. Males, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.
  11. Patients must provide written informed consent.

Exclusion Criteria:

  1. Previous treatment with BV
  2. Peripheral neuropathy > grade 1.
  3. Known history of any of the following cardiovascular conditions:

    1. Myocardial infarction within 2 years of study entry.
    2. Congestive heart failure, Class III or IV, by the NYHA criteria.
    3. Evidence of current uncontrolled cardiac arrhythmias, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
    4. Recent evidence (within 6 months of study entry) of a left ventricular ejection fraction <50%4) History of another primary malignancy for within 3 years of study entry. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)

5) Known cerebral/meningeal disease. 6) Signs or symptoms of progressive multifocal leukoencephalopathy (PML). 7) Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of BV. 8) Current therapy with other systemic anti-neoplastic or investigational agents.

9) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of BV. 10) Women who are pregnant or lactating and breastfeeding. 11) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation of brentuximab vedotin. 12) Known human immunodeficiency virus (HIV) positive. 13) Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.

14) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02227433
Other Study ID Numbers  ICMJE FIL_BVHD01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione Italiana Linfomi ONLUS
Study Sponsor  ICMJE Fondazione Italiana Linfomi ONLUS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vittorio Stefoni AO S. Orsola Malpighi
PRS Account Fondazione Italiana Linfomi ONLUS
Verification Date July 2018

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