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Bcl-2 Inhibitor

ABT-263 + Rituximab for Blood Cancers

Phase 1
Waitlist Available
Research Sponsored by AbbVie (prior sponsor, Abbott)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with a CD20-positive lymphoproliferative disorder (Revised European American Lymphoma [REAL]/World Health Organization [WHO]) and bi-dimensionally measurable disease with at least 1 lesion >= 1.0 cm
Participant must have adequate renal, hepatic and coagulation function per local laboratory reference range as follows: Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min; AST and ALT <= 3.0 × the upper normal limit (ULN); Bilirubin <= 1.5 × ULN. Participants with Gilbert's Syndrome may have a Bilirubin > 1.5 × ULN; activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 × ULN
Must not have
History of or clinically suspicious for cancer-related Central Nervous System (CNS) disease, allogeneic stem cell transplant, recurrent significant infections, previous or current malignancies within the last 5 years (except: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent), toxicity from rituximab that resulted in permanent discontinuation of treatment or toxicity from ABT-263 or another Bcl-2 family protein inhibitor, significant cardiovascular disease (e.g., MI within 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic or hepatic disease that would adversely affect participation, severe (defined as Grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination therapy for lymphoproliferative disorders. It will last up to 12 years, with participants being monitored quarterly.

Who is the study for?
This trial is for adults with certain types of lymphoid cancers, like non-Hodgkin's lymphoma or chronic lymphocytic leukemia. They should be relatively healthy (ECOG score <=1), have good kidney, liver, and blood clotting function, and not be pregnant or breastfeeding. Participants need measurable disease and can't join if they've had recent significant bleeding issues, other cancers in the last 5 years (with some exceptions), severe allergies to monoclonal antibodies, major organ diseases, or active infections.
What is being tested?
The study tests ABT-263 combined with rituximab against various lymphoid cancers over a long period (up to 13 years). It's an early-phase trial focused on safety where participants will receive the treatment combination and undergo regular health checks every three months to monitor effects.
What are the potential side effects?
Possible side effects include bleeding problems due to low platelet counts; potential liver issues reflected by changes in enzymes AST/ALT; kidney function impacts shown by creatinine levels; fatigue; allergic reactions related to rituximab or ABT-263; and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a CD20-positive lymphoma with a measurable lesion.
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My kidney, liver, and blood clotting functions are within normal ranges.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have severe health issues that could affect my trial participation.
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I do not have any uncontrolled conditions like a serious fungal infection or recent fever with low white blood cells.
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I have a bleeding condition or have had significant bleeding in the past 6 months.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 1 & 2 trial • 60 Patients • NCT00481091
75%
DIARRHOEA
50%
VOMITING
50%
COUGH
50%
HERPES SIMPLEX
50%
NAUSEA
50%
FATIGUE
50%
UPPER RESPIRATORY TRACT INFECTION
50%
DECREASED APPETITE
25%
VENTRICULAR EXTRASYSTOLES
25%
NEUTROPENIA
25%
PYREXIA
25%
GASTROENTERITIS SALMONELLA
25%
SUPERFICIAL SPREADING MELANOMA STAGE UNSPECIFIED
25%
NEURALGIA
25%
PNEUMONITIS
25%
LYMPHADENOPATHY
25%
THROMBOCYTOPENIA
25%
ABDOMINAL PAIN
25%
CONSTIPATION
25%
INFLUENZA LIKE ILLNESS
25%
CELLULITIS
25%
EYE INFECTION
25%
NASOPHARYNGITIS
25%
ORAL HERPES
25%
VIRAL INFECTION
25%
CONTUSION
25%
DEHYDRATION
25%
LIMB DISCOMFORT
25%
LETHARGY
25%
NEUROPATHY PERIPHERAL
25%
DYSPNOEA
25%
PRODUCTIVE COUGH
25%
SINUS CONGESTION
25%
WHEEZING
25%
COLD SWEAT
25%
LOWER RESPIRATORY TRACT INFECTION
25%
DYSPEPSIA
25%
CHEST PAIN
25%
FEELING HOT
25%
OEDEMA PERIPHERAL
25%
HYPOMAGNESAEMIA
25%
SECRETION DISCHARGE
25%
ALLERGY TO ARTHROPOD BITE
25%
INFLUENZA
25%
SINUSITIS
25%
BACK PAIN
25%
OSTEOPENIA
25%
BASAL CELL CARCINOMA
25%
SQUAMOUS CELL CARCINOMA OF SKIN
25%
HEADACHE
25%
OROPHARYNGEAL PAIN
25%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Navitoclax 21/21 Day Cycle: 200 mg
Phase 2: Navitoclax 100 mg
Navitoclax 14/21 Day Cycle: 200 mg
Navitoclax 21/21 Day Cycle: 125 mg
Navitoclax 14/21 Day Cycle: 250 mg
Navitoclax 21/21 Day Cycle: 250 mg
Phase 2: Navitoclax 250 mg
Navitoclax 21/21 Day Cycle: 300 mg
Navitoclax 14/21 Day Cycle: 10 mg
Navitoclax 14/21 Day Cycle: 110 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABT-263 + rituximabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rituximab
2000
Completed Phase 3
~2760
ABT-263
2008
Completed Phase 2
~690

Find a Location

Who is running the clinical trial?

AbbVie (prior sponsor, Abbott)Lead Sponsor
229 Previous Clinical Trials
148,441 Total Patients Enrolled
AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,260 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,407 Total Patients Enrolled

Media Library

ABT-263 (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00788684 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: ABT-263 + rituximab
Chronic Lymphocytic Leukemia Clinical Trial 2023: ABT-263 Highlights & Side Effects. Trial Name: NCT00788684 — Phase 1
ABT-263 (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00788684 — Phase 1
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