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Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CAPTIVATE)

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ClinicalTrials.gov Identifier: NCT02910583
Recruitment Status : Active, not recruiting
First Posted : September 22, 2016
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
This is a multicenter, 2-cohort Phase 2 study assessing both MRD-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL

Condition or disease Intervention/treatment Phase
Leukemia, Chronic Lymphocytic Lymphoma, Small Lymphocytic Drug: ibrutinib Drug: placebo to match ibrutinib Drug: venetoclax Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : October 1, 2020
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arm Intervention/treatment
Experimental: MRD Cohort Randomized ibrutinib (blinded)
Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-negative will be randomized to receive ibrutinib 420 mg capsules orally once daily on a continuous schedule until clinical disease progression or unacceptable toxicity
Drug: ibrutinib
ibrutinib 420mg capsules administered orally once daily

Drug: venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.

Placebo Comparator: MRD Cohort Randomized Placebo to match ibrutinib (blinded)
Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-negative will be randomized to receive matching ibrutinib placebo capsules orally once daily on a continuous schedule until MRD-positive relapse, clinical disease progression or unacceptable toxicity.
Drug: ibrutinib
ibrutinib 420mg capsules administered orally once daily

Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally once daily

Drug: venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.

Experimental: MRD Cohort Randomized open-label ibrutinib + venetoclax
Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-positive will be randomized to receive ibrutinib 420 mg capsules and venetoclax 400 mg tablets orally once daily on a continuous schedule until clinical disease progression or unacceptable toxicity.
Drug: ibrutinib
ibrutinib 420mg capsules administered orally once daily

Drug: venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.

Experimental: MRD Cohort Randomized open-label ibrutinib
Subjects will receive 420 mg capsules of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization. Subjects that are MRD-positive will be randomized to receive ibrutinib 420 mg capsules orally once daily on a continuous scheduled until clinical disease progression or unacceptable toxicity.
Drug: ibrutinib
ibrutinib 420mg capsules administered orally once daily

Drug: venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.

Experimental: Fixed Duration Cohort - Open Label ibrutinib + venetoclax
Subjects will receive 420 mg capsules of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity.
Drug: ibrutinib
ibrutinib 420mg capsules administered orally once daily

Drug: venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.




Primary Outcome Measures :
  1. MRD-negative response rate [ Time Frame: approximately 40 months ]
  2. Disease free survival [ Time Frame: approximately 40 months ]
  3. Complete Response Rate [ Time Frame: approximately 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
  • Measurable nodal disease by computed tomography (CT)
  • Adequate hepatic, and renal function
  • Adequate hematologic function

    • absolute neutrophil count >750/µL
    • platelet count >30,000 /μL
    • hemoglobin >8.0 g/dL

Exclusion Criteria:

  • Any prior therapy used for treatment of CLL/SLL
  • Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for TLS

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): NCT02910583


Locations
Hide Hide 39 study locations
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United States, California
Site Reference ID/Investigator# 047
Duarte, California, United States, 91010
Site Reference ID/Investigator # 0008
Orange, California, United States, 92868
Site Reference ID/Investigator# 0241
San Diego, California, United States, 92093
United States, Kentucky
Site Reference ID/Investigator# 0071
Louisville, Kentucky, United States, 40207
United States, New Jersey
Site Reference ID/Investigator # 1193
New Brunswick, New Jersey, United States, 08901
United States, New York
Site Reference ID/Investigator # 0350
New Hyde Park, New York, United States, 11040
Site Reference ID/Investigator #0200
New York, New York, United States, 10065
Site Reference ID/Investigator # 0127
Rochester, New York, United States, 14627
United States, North Carolina
Site Reference ID/Investigator # 0733
Charlotte, North Carolina, United States, 28204
United States, Ohio
Site Reference ID/Investigator # 0739
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Site Reference ID/Investigator # 0069
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Site Reference ID/Investigator# 0123
Nashville, Tennessee, United States, 37203
United States, Texas
Site Reference ID/Investigator #0032
Houston, Texas, United States, 77030
United States, Washington
Site Reference ID/Investigator # 0114
Seattle, Washington, United States, 98104
Australia, New South Wales
Site Reference ID/Investigator# 0654
Kogarah, New South Wales, Australia, 2217
Australia, South Australia
Site Reference ID/Investigator # 0163
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Site Reference ID/Investigator # 0556
Clayton, Victoria, Australia, 3168
Site Reference ID/Investigator# 0501
Fitzroy, Victoria, Australia
Site Reference ID/Investigator #0715
Frankston, Victoria, Australia, 3199
Site Reference ID/Investigator # 0170
Heidelberg, Victoria, Australia, 3084
Australia
Site Reference ID/Investigator# 0633
Melbourne, Australia
Italy
Site Reference ID/Investigator #0903
Genova, Italy, 16132
Site Reference ID/Investigator #0523
Milan, Italy, 20132
Site Reference ID/Investigator # 0581
Milan, Italy, 20162
Site Reference ID/Investigator #0524
Modena, Italy, 41124
Site Reference ID/Investigator # 0582
Novara, Italy, 28100
Site Reference ID/Investigator #1175
Padova, Italy, 35128
Site Reference ID/Investigator #1182
Piacenza, Italy, 29121
New Zealand
Site Reference ID/Investigator # 0663
Takapuna, Auckland, New Zealand, 1309
Site Reference ID/Investigator # 0662
Papatoetoe, Aukland, New Zealand, 2025
Site Reference ID/Investigator # 0589
Christchurch, New Zealand, 8011
Spain
Site Reference ID/Investigator #0536
Majadahonda, Madrid, Spain, 28222
Site Reference ID/Investigator # 1197
Pamplona, Navarra, Spain, 31008
Site Reference ID/Investigator #0535
Barcelona, Spain, 08041
SIte Reference ID/Investigator #0604
Barcelona, Spain, 08908
Site Reference ID/Investigator # 1196
Granada, Spain, 18014
Site Reference ID/Investigator #0874
Madrid, Spain, 28034
Site Reference ID/Investigator #0864
Madrid, Spain, 28041
Site Reference ID/Investigator # 790
Salamanca, Spain, 37007
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
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Study Director: Joi Ninomoto, PharmD Pharmacyclics LLC.
Study Director: Jim Dean, MD, PhD Pharmacyclics LLC.
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Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02910583    
Other Study ID Numbers: PCYC-1142-CA
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
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
Venetoclax
Antineoplastic Agents