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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02475681




Registration number
NCT02475681
Ethics application status
Date submitted
12/06/2015
Date registered
19/06/2015
Date last updated
31/05/2017

Titles & IDs
Public title
Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL
Scientific title
A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
Secondary ID [1] 0 0
ACE-CL-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Chlorambucil

Active Comparator: Obinutuzumab in Combination with Chlorambucil - Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6.

Experimental: Acalabrutinib in Combination with Obinutuzumab - Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles. ACP-196 will be orally administered starting on Cycle 1 Day 1. Daily administration of ACP-196 will continue until disease progression or unacceptable toxicity.

Experimental: Acalabrutinib Monotherapy - Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.


Treatment: Drugs: Acalabrutinib


Treatment: Drugs: Obinutuzumab


Treatment: Drugs: Chlorambucil


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival in Arm A compared to Arm B
Timepoint [1] 0 0
49 months
Secondary outcome [1] 0 0
IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C
Timepoint [1] 0 0
49 months
Secondary outcome [2] 0 0
Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C
Timepoint [2] 0 0
49 months
Secondary outcome [3] 0 0
Incidence of adverse events, serious adverse events and changes in laboratory measurements in Arm A versus Arm B and Arm A versus Arm C
Timepoint [3] 0 0
49 months
Secondary outcome [4] 0 0
Overall survival in Arm A versus Arm B and Arm A versus Arm C
Timepoint [4] 0 0
49 months

Eligibility
Key inclusion criteria
- Men and women: = 65 years of age OR > 18 and < 65 years of age, provided that they
meet at least one of the following criteria:

1. Creatinine clearance 30 to 69 mL/min.

2. A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric.

- ECOG performance status of 0, 1, or 2.

- Diagnosis of CD20+ CLL.

- Active disease meeting = 1 of the following IWCLL 2008 criteria for requiring
treatment.

- Meet the following laboratory parameters:

1. 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.

2. 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. Subjects with transfusion-dependent thrombocytopenia are excluded.

3. Serum AST and ALT/SGPT = 3.0 x ULN.

4. Total bilirubin = 1.5 x ULN.

5. Estimated creatinine clearance = 30 mL/min.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any prior systemic treatment for CLL.

- Known CNS lymphoma or leukemia.

- Known prolymphocytic leukemia or history of, or currently suspected, Richter's
syndrome.

- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.

- Major surgery within 4 weeks before first dose of study drug.

- Prior malignancy, except for adequately treated lentigo maligna melanoma,
non-melanomatous skin cancer, in situ cervical carcinoma, or other malignancy treated
with no evidence of active disease > 3 years before Screening and at low risk for
recurrence.

- Significant cardiovascular disease within 6 months of screening.

- Known history of infection with HIV.

- History of stroke or intracranial hemorrhage within 6 months before randomization.

- Known history of a bleeding diathesis.

- Requires or receiving anticoagulation with warfarin or equivalent vitamin K
antagonists within 7 days of first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
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- Waratah
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- Wollongong
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- South Brisbane
Recruitment hospital [5] 0 0
- Woodville South
Recruitment hospital [6] 0 0
- Frankston
Recruitment hospital [7] 0 0
- Geelong
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment outside Australia
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Washington
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Belgium
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Antwerpen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Acerta Pharma BV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil
compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of
previously untreated chronic lymphocytic leukemia (CLL).
Trial website
https://clinicaltrials.gov/show/NCT02475681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prista Charuworn, MD
Address 0 0
Acerta Pharma BV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications