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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01087151




Registration number
NCT01087151
Ethics application status
Date submitted
11/03/2010
Date registered
16/03/2010
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety, Efficacy and Pharmacokinetics of ABT-263 in Combination With Dose-intensive Rituximab, or Dose-intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)
Secondary ID [1] 0 0
2009-012152-24
Secondary ID [2] 0 0
ABT4710n
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
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-263
Treatment: Drugs - rituximab

Active Comparator: A -

Experimental: B -

Experimental: C -


Treatment: Drugs: ABT-263
Oral repeating dose

Treatment: Drugs: rituximab
Intravenous repeating dose

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

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])
Secondary outcome [1] 0 0
Overall response rate (ORR)
Timepoint [1] 0 0
Approximately 40 months from FPI
Secondary outcome [2] 0 0
Duration of response
Timepoint [2] 0 0
Approximately 40 months from FPI
Secondary outcome [3] 0 0
Complete response (CR) rate
Timepoint [3] 0 0
Approximately 40 months from FPI
Secondary outcome [4] 0 0
Progression-free survival as assessed by a blinded, independent review
Timepoint [4] 0 0
From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI)
Secondary outcome [5] 0 0
ORR as assessed by a blinded, independent review
Timepoint [5] 0 0
Approximately 40 months from FPI
Secondary outcome [6] 0 0
Duration of response as assessed by a blinded, independent review
Timepoint [6] 0 0
Approximately 40 months from FPI
Secondary outcome [7] 0 0
CR rate as assessed by a blinded, independent review
Timepoint [7] 0 0
Approximately 40 months from FPI
Secondary outcome [8] 0 0
Overall survival (OS)
Timepoint [8] 0 0
From randomization until death due to any cause (approximately 4 years after Last Patient In)

Eligibility
Key inclusion criteria
- Previously untreated, CD20-positive B-cell CLL

- ECOG performance status of 0 or 1

- Life expectancy > 6 months

- Willingness and capability to be accessible for follow-up until study termination or
death

- For patients of reproductive potential (both males and females), use of a reliable
means of contraception
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prolymphocytic leukemia

- Richter's transformation to an aggressive B-cell malignancy (e.g., DLBCL)

- Prior radiotherapy to a lesion(s) that will be used to assess response unless that
lesion(s) shows clear evidence of progression at baseline

- Patients with a history of other malignancies within 2 years prior to study entry
except for adequately treated carcinoma in situ of the cervix, basal or squamous cell
skin carcinoma, low-grade, localized prostate cancer treated surgically with curative
intent or one that carries a good prognosis, in situ ductal carcinoma of the breast
treated with lumpectomy alone with curative intent

- Prior treatment with rituximab, ABT-263 or other pro-apoptotic agents

- Current or recent (within the 28 days prior to initiation of study treatment)
participation in another experimental drug study

- Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury
within 28 days prior to treatment onset or anticipation of the need for major surgery
during the course of the study

- Active infection requiring parenteral antibiotics or antiviral or antifungal agents at
the onset of study treatment

- Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months
prior to initiation of study treatment

- Patients receiving therapeutic anticoagulation with heparin or warfarin or patients
receiving any drugs or herbal supplements that are known to inhibit platelet function
(including low-dose aspirin) within 7 days of the first dose of ABT-263. Note:
Patients receiving low-dose anticoagulation for the purpose of maintaining central
venous catheter patency are eligible.

- Patients who have an inherited or acquired bleeding diathesis, including (but not
limited to) hemophilia or immune or thrombotic thrombocytopenic purpura, or who have
had an underlying condition that predisposes to abnormal bleeding (e.g., peptic ulcer
disease) within 1 year prior to the first dose of ABT-263

- Patients with a history of refractoriness to platelet transfusions

- Clinically significant cardiovascular disease

- Known human immunodeficiency virus (HIV) infection, seropositivity for hepatitis B
surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA

- Pregnancy or breastfeeding

- Concurrent (or within 7 days prior to the first dose of study treatment) systemic
corticosteroid therapy except some low-dose corticosteroid therapies

- History of other disease, metabolic dysfunction, physical or laboratory finding(s)
giving reasonable suspicion of a disease or condition that contraindicates use of an
investigational drug, might affect interpretation of the results of the study or
render the patient at high risk from treatment complications

- History of anaphylaxis, allergic reaction, or hypersensitivity to sulfites (sodium
metabisulphite is included in study drug formulation)

- Any contraindication to alcohol ingestion (study drug formulation includes
approximately 15% ethanol)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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,WA
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Greenslopes
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Kurralta Park
Recruitment hospital [5] 0 0
- Coburg, VIC
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Frankston
Recruitment hospital [8] 0 0
- Parkville
Recruitment hospital [9] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3058 - Coburg, VIC
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Brazil
State/province [19] 0 0
ES
Country [20] 0 0
Brazil
State/province [20] 0 0
MG
Country [21] 0 0
Brazil
State/province [21] 0 0
RJ
Country [22] 0 0
Brazil
State/province [22] 0 0
RS
Country [23] 0 0
Brazil
State/province [23] 0 0
SP
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Brno
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Hradec Kralove
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Prague 2
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Pierre Benite
Country [29] 0 0
Israel
State/province [29] 0 0
Afula
Country [30] 0 0
Israel
State/province [30] 0 0
Petah Tikva
Country [31] 0 0
Israel
State/province [31] 0 0
Ramat Gan
Country [32] 0 0
Israel
State/province [32] 0 0
Rehovot
Country [33] 0 0
Italy
State/province [33] 0 0
Emilia-Romagna
Country [34] 0 0
Italy
State/province [34] 0 0
Liguria
Country [35] 0 0
Italy
State/province [35] 0 0
Lombardia
Country [36] 0 0
Italy
State/province [36] 0 0
Piemonte
Country [37] 0 0
Poland
State/province [37] 0 0
Chorzow
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Warszawa
Country [40] 0 0
Puerto Rico
State/province [40] 0 0
San Juan
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Kazan
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Petrozavodsk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Ryazan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St. Petersburg
Country [46] 0 0
Ukraine
State/province [46] 0 0
Cherkassy
Country [47] 0 0
Ukraine
State/province [47] 0 0
Dnipropetrovsk
Country [48] 0 0
Ukraine
State/province [48] 0 0
Donetsk
Country [49] 0 0
Ukraine
State/province [49] 0 0
Ivano-Frankivsk
Country [50] 0 0
Ukraine
State/province [50] 0 0
Khmelnitskyy
Country [51] 0 0
Ukraine
State/province [51] 0 0
Kyiv
Country [52] 0 0
Ukraine
State/province [52] 0 0
Lviv
Country [53] 0 0
Ukraine
State/province [53] 0 0
Poltava
Country [54] 0 0
Ukraine
State/province [54] 0 0
Zhytomir
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Leicester
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AbbVie (prior sponsor, Abbott)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This Phase II, randomized, open-label, international, multicenter trial is designed to
evaluate the safety and efficacy of rituximab monotherapy when given according to a dose
intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when
combined with dose-intense rituximab in previously untreated patients with B-cell CLL.
Trial website
https://clinicaltrials.gov/show/NCT01087151
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Ho, M.D., Ph.D.
Address 0 0
Genentech, Inc.
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