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Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT04477486
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic system in blood) where cells from outer edge of the lymph nodes, called mantle zone become cancerous. In Japan, MCL accounts for about 3% of all NHL cases. Some symptoms of MCL are enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. MCL is not curable with standard therapies and has poor outcomes. The purpose of this study is to evaluate the safety, efficacy and effect of venetoclax in combination with ibrutinib on best overall response of complete response in participants with relapsed (return of disease) or refractory (not responding to treatment) (R/R) MCL.

Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone. Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in Japan.

Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks. After 104 weeks, participants will receive ibrutinib once daily until their disease progresses, or they cannot tolerate the medication, or until they do not want to participate in the study.

There may be a higher treatment burden for participants in this study compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, bone marrow biopsies, checking for side effects, and completing questionnaires.


Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma (MCL) Drug: Ibrutinib Drug: Venetoclax Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Efficacy and Safety of Venetoclax in Combination With Ibrutinib in Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : November 14, 2021
Estimated Study Completion Date : April 24, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Ibrutinib + Venetoclax
Participants will receive Ibrutinib Dose A + Venetoclax in various doses until a target dose is reached, for up to 104 weeks, followed by Ibrutinib monotherapy.
Drug: Ibrutinib
Capsule; Oral
Other Name: Imbruvica

Drug: Venetoclax
Tablet; Oral
Other Names:
  • ABT-199
  • Venclexta
  • GDC-0199
  • Venclyxto




Primary Outcome Measures :
  1. Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as assessed by the Independent Review Committee (IRC) [ Time Frame: At Week 13 ]
    Best overall response of CR is evaluated using the complete response rate (CRR), defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, per the Revised Criteria for Response Assessment as assessed by the Independent Review Committee (IRC).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR), as assessed by the IRC [ Time Frame: Up to Approximately 2 Years ]
    Best Overall Response of CR or PR will be evaluated using Overall Response Rate (ORR). The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment, as assessed by the IRC.

  2. Percentage of Participants Achieving Best Overall Response of Complete Response as assessed by the Investigator [ Time Frame: Up to Approximately 2 Years ]
    Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment.

  3. Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR), as assessed by the Investigator [ Time Frame: Up to Approximately 2 Years ]
    Best Overall Response of CR or PR will be evaluated using Overall Response Rate (ORR). The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment, as assessed by the investigator.

  4. Percentage of Participants Achieving Duration of Response (DOR) for a Best Overall Response, as assessed by the Investigator [ Time Frame: Up to Approximately 2 Years ]
    DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment, as assessed by the investigator.

  5. Percentage of Participants Achieving Duration of Response (DOR) for a Best Overall Response, as assessed by the IRC [ Time Frame: Up to Approximately 2 Years ]
    DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment, as assessed by the Independent Review Committee (IRC).

  6. Percentage of Participants Achieving an Undetectable Minimal Residual Disease (MRD) who Achieve a Best Overall Response, as assessed by the Investigator [ Time Frame: Up to Approximately 2 Years ]
    MRD rate is defined as the percentage of participants with undetectable MRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment, as assessed by the investigator.

  7. Percentage of Participants Achieving Undetectable Minimal Residual Disease (MRD) in Participants who Achieve a Best Overall Response of CR, as assessed by the IRC [ Time Frame: Up to Approximately 2 Years ]
    MRD rate is defined as the percentage of participants with undetectable MRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment, as assessed by the IRC.

  8. Progression-Free Survival (PFS) [ Time Frame: Up to Approximately 2 Years ]
    PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment of Malignant Lymphoma, or death from any cause, whichever occurs first.

  9. Overall Survival (OS) [ Time Frame: Up to Approximately 2 Years ]
    OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause.



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.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed Mantle Cell Lymphoma (MCL) (tumor tissue) by local testing.
  • At least 1 measurable site of disease on cross-sectional imaging that is >= 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per Computed Tomography (CT).
  • At least 1, but no more than 5, prior treatment regimens for MCL including at least 1 prior rituximab/anti-CD20 containing regimen.
  • Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.

Exclusion Criteria:

  • Prior therapy with ibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.
  • History of other malignancies, except:

    • Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without evidence of disease.
  • History or current evidence of central nervous system lymphoma.
  • Treatment with any of the following within 7 days prior to the first dose of study drug:

    • Moderate or strong cytochrome P450 3A (CYP3A) inhibitors.
    • Moderate or strong CYP3A inducers.
    • Anticancer therapy, including chemotherapy, radiotherapy, small molecule, and investigational agents, and/or monoclonal antibody <=21 days prior to the first dose of study drug.

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): NCT04477486


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Japan
NHO Nagoya Medical Center /ID# 221958 Recruiting
Nagoya-shi, Aichi, Japan, 460-0001
Aichi Cancer Center Hospital /ID# 221565 Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
Kyushu University Hospital /ID# 223299 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Hokkaido University Hospital /ID# 221662 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital /ID# 221744 Recruiting
Kobe-shi, Hyogo, Japan, 650-0047
National Hospital Organization Mito Medical Center /ID# 224912 Not yet recruiting
Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
Ishikawa Prefectural Central Hospital /ID# 224896 Not yet recruiting
Kanazawa-shi, Ishikawa, Japan, 〒920-8530
Tohoku University Hospital /ID# 221975 Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Okayama University Hospital /ID# 221623 Recruiting
Okayama-shi, Okayama, Japan, 700-8558
Saitama Medical Center /ID# 224910 Not yet recruiting
Kawagoe-shi, Saitama, Japan, 350-8550
National Cancer Center Hospital /ID# 221812 Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Yamagata University Hospital /ID# 221573 Recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04477486    
Other Study ID Numbers: M20-075
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
MCL
Venetoclax
ABT-199
Ibrutinib
Imbruvica
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Venetoclax
Antineoplastic Agents