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)

NCT01087151 | Completed Phase 2

• 3 other identifiers: ABT4710n2009-012152-24GP00763
• Study Type: interventional
• Target: 118
• Locations: 12 countries
• Sites: 103

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Rituxan; Apoptosis; BCl-2

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

Secondary Outcomes (8)

• Overall response rate (ORR)

  Approximately 40 months from FPI

• Duration of response

  Approximately 40 months from FPI

• Complete response (CR) rate

  Approximately 40 months from FPI

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

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

• ORR as assessed by a blinded, independent review

  Approximately 40 months from FPI

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: rituximab

B

EXPERIMENTAL

Drug: ABT-263; Drug: rituximab

C

EXPERIMENTAL

Drug: ABT-263; Drug: rituximab

Interventions

ABT-263 DRUG

Oral repeating dose

B; C

rituximab DRUG

Intravenous repeating dose

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• AbbVie (prior sponsor, Abbott): collaborator

Study Sites (103)

Unknown Facility

Alhambra, California, 91801, United States

Location

Unknown Facility

Antioch, California, 94531, United States

Location

Unknown Facility

Berkeley, California, 94704, United States

Location

Unknown Facility

Burbank, California, 91505, United States

Location

Unknown Facility

Duarte, California, 91010, United States

Location

Unknown Facility

Dublin, California, 94568, United States

Location

Unknown Facility

La Jolla, California, 92093, United States

Location

Unknown Facility

Los Angeles, California, 90024, United States

Location

Unknown Facility

Los Angeles, California, 90073, United States

Location

Unknown Facility

Los Angeles, California, 90095-1772, United States

Location

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Northridge, California, 91325, United States

Location

Unknown Facility

Pleasant Hill, California, 94523, United States

Location

Unknown Facility

San Leandro, California, 94578-2626, United States

Location

Unknown Facility

San Luis Obispo, California, 93454, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Fort Collins, Colorado, 80528, United States

Location

Unknown Facility

Norwalk, Connecticut, 06856, United States

Location

Unknown Facility

Bay Pines, Florida, 33744, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Decatur, Illinois, 62526, United States

Location

Unknown Facility

Harvey, Illinois, 60426, United States

Location

Unknown Facility

Tinley Park, Illinois, 60477, United States

Location

Unknown Facility

Shreverport, Louisiana, 71103, United States

Location

Unknown Facility

Baltimore, Maryland, 21215, United States

Location

Unknown Facility

Bethesda, Maryland, 20817, United States

Location

Unknown Facility

Bethesda, Maryland, 20874, United States

Location

Unknown Facility

Randallstown, Maryland, 21133, United States

Location

Unknown Facility

Lansing, Michigan, 48909, United States

Location

Unknown Facility

Lansing, Michigan, 48912, United States

Location

Unknown Facility

Omaha, Nebraska, 68114, United States

Location

Unknown Facility

Henderson, Nevada, 89052, United States

Location

Unknown Facility

Las Vegas, Nevada, 89148, United States

Location

Unknown Facility

Las Vegas, Nevada, 89169, United States

Location

Unknown Facility

Reno, Nevada, 89502, United States

Location

Unknown Facility

Cherry Hill, New Jersey, 08003, United States

Location

Unknown Facility

Farmington, New Mexico, 87401, United States

Location

Unknown Facility

Oneida, New York, 13421, United States

Location

Unknown Facility

Oswego, New York, 13126, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

Unknown Facility

Middletown, Ohio, 45042, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19111, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15224, United States

Location

Unknown Facility

Corpus Christi, Texas, 78405, United States

Location

Unknown Facility

Lubbock, Texas, 79410, United States

Location

Unknown Facility

Lubbock, Texas, 79415, United States

Location

Unknown Facility

Everett, Washington, 98201, United States

Location

Unknown Facility

Randwick, New South Wales, 2031, Australia

Location

Unknown Facility

Greenslopes, Queensland, 4120, Australia

Location

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Unknown Facility

Kurralta Park, South Australia, 5037, Australia

Location

Unknown Facility

Coburg, VIC, Victoria, 3058, Australia

Location

Unknown Facility

Fitzroy, Victoria, 3065, Australia

Location

Unknown Facility

Frankston, Victoria, 3199, Australia

Location

Unknown Facility

Parkville, Victoria, 3052, Australia

Location

Unknown Facility

Fremantle, Western Australia, 6160, Australia

Location

Unknown Facility

Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil

Location

Unknown Facility

Belo Horizonte, Minas Gerais, 30150-270, Brazil

Location

Unknown Facility

Belo Horizonte, Minas Gerais, 30150-281, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil

Location

Unknown Facility

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

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Unknown Facility

Santo André, São Paulo, 09060-650, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01427-001, Brazil

Location

Unknown Facility

Brno, 625 00, Czechia

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Prague, 128 08, Czechia

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Afula, 18101, Israel

Location

Unknown Facility

Petah Tikva, 4937211, Israel

Location

Unknown Facility

Ramat Gan, 5262100, Israel

Location

Unknown Facility

Rehovot, 76100, Israel

Location

Unknown Facility

Modena, Emilia-Romagna, 41100, Italy

Location

Unknown Facility

Genoa, Liguria, 16128, Italy

Location

Unknown Facility

Cremona, Lombardy, 26100, Italy

Location

Unknown Facility

Milan, Lombardy, 20133, Italy

Location

Unknown Facility

Milan, Lombardy, 20162, Italy

Location

Unknown Facility

Rozzano, Lombardy, 20089, Italy

Location

Unknown Facility

Turin, Piedmont, 10128, Italy

Location

Unknown Facility

Chorzów, 41-500, Poland

Location

Unknown Facility

Gdansk, 80-952, Poland

Location

Unknown Facility

Warsaw, 00-909, Poland

Location

Unknown Facility

San Juan, 00927, Puerto Rico

Location

Unknown Facility

Kazan', 420029, Russia

Location

Unknown Facility

Moscow, 115478, Russia

Location

Unknown Facility

Petrozavodsk, 185019, Russia

Location

Unknown Facility

Ryazan, 390039, Russia

Location

Unknown Facility

Saint Petersburg, 191024, Russia

Location

Unknown Facility

Cherkassy, 18009, Ukraine

Location

Unknown Facility

Dnipropetrovsk, 49102, Ukraine

Location

Unknown Facility

Donetsk, 83045, Ukraine

Location

Unknown Facility

Ivano-Frankivsk, 76018, Ukraine

Location

Unknown Facility

Khmelnitskyy, 29000, Ukraine

Location

Unknown Facility

Kyiv, 03150, Ukraine

Location

Unknown Facility

Lviv, 79044, Ukraine

Location

Unknown Facility

Poltava, 36024, Ukraine

Location

Unknown Facility

Zhytomyr, 10002, Ukraine

Location

Unknown Facility

Leicester, LE1 5WW, United Kingdom

Location

Unknown Facility

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

navitoclax; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• William Ho, M.D., Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 16, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

AU (9); FR (2); UA (9); BR (10); CZ (3); US (48); GB (2); PL (3); IT (7); PR (1); RU (5); IL (4)