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Trial record 1 of 1 for:    NCT02970318
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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
November 18, 2016
November 22, 2016
May 25, 2017
September 2016
January 2020   (Final data collection date for primary outcome measure)
IRC-assessed progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]
Progression-free survival (PFS) in Arm A compared to Arm B [ Time Frame: 48 months ]
Complete list of historical versions of study NCT02970318 on ClinicalTrials.gov Archive Site
  • 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 ]
  • IRC-assessed overall response rate (ORR) 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 ]
  • Overall survival (OS) in Arm A compared to Arm B [ Time Frame: 48 months ]
  • Duration of response (DOR) 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 ]
Not Provided
Not Provided
 
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: Acalabrutinib (ACP-196)
  • Drug: Rituximab
  • Drug: Idelalisib
  • Drug: Bendamustine
  • Experimental: Acalabrutinib (ACP-196)
    Acalabrutinib (ACP-196) Monotherapy
    Intervention: Drug: Acalabrutinib (ACP-196)
  • Active Comparator: Rituximab Plus Idelalisib or Bendamustine
    Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine
    Interventions:
    • Drug: Rituximab
    • Drug: Idelalisib
    • Drug: Bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
306
March 2020
January 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Julie Stewart 6505912800 ext 167
Contact: Jeannine Madere 6505912800 ext 231
United States
 
 
NCT02970318
ACE-CL-309
Yes
Not Provided
Not Provided
Acerta Pharma BV
Acerta Pharma BV
Not Provided
Study Director: Priti Patel, MD Acerta Pharma BV
Acerta Pharma BV
May 2017

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