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Chronic Lymphocytic LeukemiaPhase 2NCT01087151

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)

A Phase 2 study testing ABT-263 and rituximab in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc. at 103 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
ABT-263 and rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
103 sitesin 12 countries
Study dates
Aug 2010to Jun 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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)

Trial locations and contacts

103 sites in 12 countries.

103 sites in 12 countries

United States48 sites

  • Study site

    Alhambra, California, 91801

  • Study site

    Antioch, California, 94531

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Berkeley, California, 94704

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Bethesda, Maryland, 20874

  • Study site

    Burbank, California, 91505

  • Study site

    Cherry Hill, New Jersey, 08003

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Corpus Christi, Texas, 78405

  • Study site

    Decatur, Illinois, 62526

  • Study site

    Duarte, California, 91010

  • Study site

    Dublin, California, 94568

  • Study site

    Everett, Washington, 98201

  • Study site

    Farmington, New Mexico, 87401

  • Study site

    Fort Collins, Colorado, 80528

  • Study site

    Harvey, Illinois, 60426

  • Study site

    Henderson, Nevada, 89052

  • Study site

    La Jolla, California, 92093

  • Study site

    Lansing, Michigan, 48909

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Las Vegas, Nevada, 89148

  • Study site

    Las Vegas, Nevada, 89169

  • Study site

    Los Angeles, California, 90024

  • Study site

    Los Angeles, California, 90073

  • Study site

    Los Angeles, California, 90095-1772

  • Study site

    Los Angeles, California, 90095

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Lubbock, Texas, 79415

  • Study site

    Middletown, Ohio, 45042

  • Study site

    Northridge, California, 91325

  • Study site

    Norwalk, Connecticut, 06856

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Oneida, New York, 13421

  • Study site

    Oswego, New York, 13126

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Pleasant Hill, California, 94523

  • Study site

    Randallstown, Maryland, 21133

  • Study site

    Reno, Nevada, 89502

  • Study site

    San Leandro, California, 94578-2626

  • Study site

    San Luis Obispo, California, 93454

  • Study site

    Santa Monica, California, 90404

  • Study site

    Shreverport, Louisiana, 71103

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tinley Park, Illinois, 60477

Other trials in United States

Brazil10 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-270

  • Study site

    Belo Horizonte, Minas Gerais, 30150-281

  • Study site

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Study site

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20211-030

  • Study site

    Santo André, São Paulo, 09060-650

  • Study site

    São Paulo, São Paulo, 01427-001

Other trials in Brazil

Australia9 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Coburg, VIC, Victoria, 3058

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Fremantle, Western Australia, 6160

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Kurralta Park, South Australia, 5037

  • Study site

    Parkville, Victoria, 3052

  • Study site

    Randwick, New South Wales, 2031

Other trials in Australia

Ukraine9 sites

  • Study site

    Cherkassy, 18009

  • Study site

    Dnipropetrovsk, 49102

  • Study site

    Donetsk, 83045

  • Study site

    Ivano-Frankivsk, 76018

  • Study site

    Khmelnitskyy, 29000

  • Study site

    Kyiv, 03150

  • Study site

    Lviv, 79044

  • Study site

    Poltava, 36024

  • Study site

    Zhytomyr, 10002

Other trials in Ukraine

Italy7 sites

  • Study site

    Cremona, Lombardy, 26100

  • Study site

    Genoa, Liguria, 16128

  • Study site

    Milan, Lombardy, 20133

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Rozzano, Lombardy, 20089

  • Study site

    Turin, Piedmont, 10128

Other trials in Italy

Russia5 sites

  • Study site

    Kazan', 420029

  • Study site

    Moscow, 115478

  • Study site

    Petrozavodsk, 185019

  • Study site

    Ryazan, 390039

  • Study site

    Saint Petersburg, 191024

Other trials in Russia

Israel4 sites

  • Study site

    Afula, 18101

  • Study site

    Petah Tikva, 4937211

  • Study site

    Ramat Gan, 5262100

  • Study site

    Rehovot, 76100

Other trials in Israel

Czechia3 sites

  • Study site

    Brno, 625 00

  • Study site

    Hradec Králové, 500 05

  • Study site

    Prague, 128 08

Other trials in Czechia

Poland3 sites

  • Study site

    Chorzów, 41-500

  • Study site

    Gdansk, 80-952

  • Study site

    Warsaw, 00-909

Other trials in Poland

France2 sites

  • Study site

    Lille, 59037

  • Study site

    Pierre-Bénite, 69495

Other trials in France

United Kingdom2 sites

  • Study site

    Leicester, LE1 5WW

  • Study site

    London, EC1A 7BE

Other trials in United Kingdom

Puerto Rico1 site

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official 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)

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.

Being tested
ABT-263, rituximab
Keywords
Rituxan, Apoptosis, BCl-2
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-263Drug

    Oral repeating dose

  • rituximabDrug

    Intravenous repeating dose

Study groups in NCT01087151
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: rituximab
BExperimentalNot described
Receives: Drug: ABT-263; Drug: rituximab
CExperimentalNot described
Receives: Drug: ABT-263; Drug: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])

Secondary outcomes (8)

  1. Overall response rate (ORR)

    Measured: Approximately 40 months from FPI

  2. Duration of response

    Measured: Approximately 40 months from FPI

  3. Complete response (CR) rate

    Measured: Approximately 40 months from FPI

  4. Progression-free survival as assessed by a blinded, independent review

    Measured: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI)

  5. ORR as assessed by a blinded, independent review

    Measured: Approximately 40 months from FPI

  6. Duration of response as assessed by a blinded, independent review

    Measured: Approximately 40 months from FPI

  7. CR rate as assessed by a blinded, independent review

    Measured: Approximately 40 months from FPI

  8. Overall survival (OS)

    Measured: From randomization until death due to any cause (approximately 4 years after Last Patient In)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01087151
Sponsor's protocol ID
ABT4710n
Other IDs
2009-012152-24, GP00763, 2009
Status last verified
Nov 2016
First submitted
11 Mar 2010
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-263 and rituximab in people with Chronic Lymphocytic Leukemia, run by Genentech, Inc. at 103 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Brazil, Australia, Ukraine, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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