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Trial record 5 of 10 for:    acp-196 cll

A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

This study is currently recruiting participants.
Verified May 2017 by Acerta Pharma BV
Sponsor:
ClinicalTrials.gov Identifier:
NCT02970318
First Posted: November 22, 2016
Last Update Posted: May 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Acerta Pharma BV
  Purpose
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: Acalabrutinib (ACP-196) Drug: Rituximab Drug: Idelalisib Drug: Bendamustine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • IRC-assessed progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • Investigator-assessed progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Investigator and IRC-assessed overall response rate (ORR) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Overall survival (OS) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Patient reported outcomes (PROs) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Investigator and IRC-assessed duration of response (DOR) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Time to next treatment (TTNT) in Arm A compared to Arm B [ Time Frame: 48 months ]

Estimated Enrollment: 306
Study Start Date: September 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acalabrutinib (ACP-196)
Acalabrutinib (ACP-196) Monotherapy
Drug: Acalabrutinib (ACP-196)
Active Comparator: Rituximab Plus Idelalisib or Bendamustine
Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine
Drug: Rituximab Drug: Idelalisib Drug: Bendamustine

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • ECOG performance status of 0 to 2.
  • Received ≥ 1 prior systemic therapies for CLL.
  • Diagnosis of CLL - CD-20 positive, and meeting published criteria (Hallek, 2008).
  • Active disease meeting ≥ 1 of the IWCLL 2008 criteria for requiring treatment.
  • Meet the following laboratory parameters:

    • ANC ≥ 750 cells/μL or ≥ 500 cells/μL in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
    • Platelet count ≥ 50,000 cells/μL or ≥ 30,000 cells/μL in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment.
    • AST and ALT ≤ 2.0 x upper limit of normal
    • Total bilirubin ≤ 1.5 x ULN.
    • Estimated creatinine clearance of ≥ 30 mL/min

Exclusion Criteria:

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome. Known CNS lymphoma or leukemia.
  • Prior exposure to a BCL-2 inhibitor or B-cell receptor inhibitor.
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
  • Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
  • Prior radio- or toxin-conjugated antibody therapy.
  • Major surgery within 30 days of first dose of study drug.
  • Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, carcinoma in situ or other malignancy treated with no evidence of active disease > 2 years before Screening and at low risk for recurrence.
  • Significant cardiovascular disease within 6 months of screening.
  • Known history of infection with HIV, or any uncontrolled active systemic infection.
  • Active CMV infection.
  • Serologic status reflecting active hepatitis B or C infection.
  • History of or ongoing drug-induced pneumonitis.
  • Malabsorption syndrome, or other condition that would impair absorption of oral study medication.
  • Received a live virus vaccination within 28 days of first dose of study drug.
  • History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
  • History of bleeding diathesis.
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
  • Requires treatment with a strong CYP3A inhibitor/inducer.
  Contacts and Locations
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): NCT02970318


Contacts
Contact: Julie Stewart 6505912800 ext 167
Contact: Jeannine Madere 6505912800 ext 231

Locations
United States, California
Ventura County Hematology-Oncology Specialists Recruiting
Oxnard, California, United States, 93030
United States, Illinois
Joliet Oncology Hematology Associates, Ltd Recruiting
Joliet, Illinois, United States, 60435
United States, Iowa
Physicians Clinic of Iowa, P.C. Recruiting
Cedar Rapids, Iowa, United States, 52403
United States, Kentucky
Montgomery Cancer Center Recruiting
Mount Sterling, Kentucky, United States, 40353
United States, Minnesota
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
United States, Nebraska
Nebraska Hematology-Oncology Recruiting
Lincoln, Nebraska, United States, 68506
United States, New Jersey
New Jersey Hematology / Oncology Associates Recruiting
Bricktown, New Jersey, United States, 08724
United States, New York
Hematology Oncology Associates of Rockland Recruiting
Nyack, New York, United States, 10960
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Baylor Scott & White Health Recruiting
Round Rock, Texas, United States, 78665
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Priti Patel, MD Acerta Pharma BV
  More Information

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02970318     History of Changes
Other Study ID Numbers: ACE-CL-309
First Submitted: November 18, 2016
First Posted: November 22, 2016
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Acerta Pharma BV:
CLL
BTK
Bruton Tyrosine Kinase
acalabrutinib
ACP-196

Additional relevant MeSH terms:
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
Idelalisib
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors