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A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03406156
Recruitment Status : Active, not recruiting
First Posted : January 23, 2018
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
A study in previously untreated Chronic Lymphocytic Leukemia participants to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Drug: Obinutuzumab Drug: Bendamustine Drug: Venetoclax Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : September 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax

Debulking Period: Obinutuzumab with or without bendamustine (bendamustine administered in participants with high tumor load as described in the protocol) during the debulking period (up to 6 cycles).

Treatment Period: Venetoclax + obinutuzumab regimen initiated when participant achieves low tumor burden during debulking period, or if the participant has not achieved low tumor burden status after 6 cycles of debulking, the participant may proceed to venetoclax per the discretion of the treating provider after discussion with the study physician. During this regimen period, participants to receive obinutuzumab in combination with venetoclax for 5 months then venetoclax therapy alone to continue for a total duration of up to 53 weeks.

 Drug: Obinutuzumab
intravenous
Other Name: Gazyva

Drug: Bendamustine
intravenous
Other Name: Bendeka

Drug: Venetoclax
tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period) [ Time Frame: Up to approximately 24 weeks after initial dose of study drug ]
    Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.

  2. Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi) [ Time Frame: Up to approximately 65 weeks after initial dose of venetoclax ]
    Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group [IWCLL NCI-WG] criteria).


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]
    ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission [nPR] plus partial remission [PR]) per the 2008 Modified IWCLL NCI-WG criteria.

  2. Duration of Response (DoR) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]
    DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).

  3. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]
    PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.

  4. Time to Progression (TTP) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]
    TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.

  5. Overall Survival (OS) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]
    OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.

  6. Undetectable Minimal Residual Disease (UMRD) Rate [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]
    UMRD defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of UMRD status will be defined as the percentage of participants who have UMRD.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adequate hematology, kidney and liver function as described in the protocol.
  • Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.
  • CLL requires treatment according to the IWCLL criteria.
  • Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 × 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 × 10^9/L and LN >= 5 cm).

Exclusion Criteria:

  • Presence of 17p deletion at Screening.
  • Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).
  • Prolymphocytic leukemia.
Contacts and Locations
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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): NCT03406156


Locations
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United States, Arizona
Arizona Oncology Associates, PC-HOPE /ID# 202335
Tucson, Arizona, United States, 85711-2701
United States, Colorado
Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328
Denver, Colorado, United States, 80218
United States, Missouri
MidAmerica Division, Inc. /ID# 201099
Kansas City, Missouri, United States, 64132
United States, Ohio
Oncology Hematology Care, Inc - Kenwood /ID# 202397
Cincinnati, Ohio, United States, 45236-2725
United States, Oregon
Willamette Valley Cancer Institute /ID# 201201
Eugene, Oregon, United States, 97401-6043
United States, South Carolina
Greenville Health System - Int'l Dr /ID# 202329
Greenville, South Carolina, United States, 29615
United States, Tennessee
Tennessee Oncology - Chattanooga /ID# 202840
Chattanooga, Tennessee, United States, 37404-1108
Tennessee Oncology-Nashville Centennial /ID# 201098
Nashville, Tennessee, United States, 37203-1632
United States, Texas
Texas Oncology - Austin Midtown /ID# 201199
Austin, Texas, United States, 78705
Texas Oncology - Beaumont /ID# 202359
Beaumont, Texas, United States, 77701-4691
Texas Oncology - Medical City Dallas /ID# 201196
Dallas, Texas, United States, 75230
Texas Oncology - McAllen /ID# 202331
McAllen, Texas, United States, 78503
Texas Oncology - San Antonio Medical Center /ID# 202332
San Antonio, Texas, United States, 78240-5251
Texas Oncology - Tyler /ID# 201211
Tyler, Texas, United States, 75702
United States, Washington
Northwest Cancer Specialists, P.C. /ID# 201198
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03406156    
Other Study ID Numbers: M16-788
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 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)
Analytic Code
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.: No
Keywords provided by AbbVie:
Cancer
Chronic Lymphocytic Leukemia
17p Deletion
debulking
obinutuzumab
 bendamustine
tumor lysis syndrome
venetoclax
Small Lymphocytic Lymphoma
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Leukemia, B-Cell
Bendamustine Hydrochloride
Venetoclax
Obinutuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological