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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
Adequate bone marrow function, independent of growth factor support (with the exception of participants with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve Absolute Neutrophil count (ANC) eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) >= 1000/μL; Platelets >= 100,000/mm3 (untransfused); Hemoglobin >= 9.0 g/dL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pfs will be measured upon study completion via statistical analysis of the study data.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 blood counts meet the required levels for treatment.
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I am not pregnant, and if capable of becoming pregnant, I am using effective birth control.
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I had a stem cell transplant over 6 months ago and my blood counts meet the required levels.
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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.
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My platelet count is above 25,000/mm3 without transfusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety will be assessed until the participant discontinues the extension portion of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety will be assessed until the participant discontinues the extension portion of the study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the safety profile and characterize the pharmacokinetics of ABT-263 when administered in combination with rituximab
Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) when ABT-263 is administered in combination with rituximab
Extension Study: Continued assessment of the safety profile of ABT-263 when administered in combination with rituximab
Secondary outcome measures
Extension Study: Continued assessment of the preliminary progression-free survival (PFS), response rate, and duration of response.
Preliminary progression-free survival (PFS), response rate, and duration of response.

Side effects data

From 2022 Phase 1 & 2 trial • 60 Patients • NCT00481091
74%
DIARRHOEA
48%
THROMBOCYTOPENIA
48%
NAUSEA
37%
FATIGUE
30%
UPPER RESPIRATORY TRACT INFECTION
30%
DECREASED APPETITE
26%
OEDEMA PERIPHERAL
26%
NEUTROPENIA
22%
COUGH
19%
PAIN IN EXTREMITY
19%
DYSPEPSIA
19%
VOMITING
19%
NASOPHARYNGITIS
19%
URINARY TRACT INFECTION
19%
ARTHRALGIA
15%
ANAEMIA
15%
PYREXIA
15%
DIZZINESS
11%
ANXIETY
11%
ABDOMINAL DISCOMFORT
11%
ABDOMINAL PAIN UPPER
11%
HYPERURICAEMIA
11%
BRONCHITIS
11%
CONTUSION
11%
ALANINE AMINOTRANSFERASE INCREASED
11%
WEIGHT DECREASED
11%
BACK PAIN
11%
HEADACHE
11%
TASTE DISORDER
11%
INSOMNIA
11%
EPISTAXIS
11%
RASH
7%
GASTROOESOPHAGEAL REFLUX DISEASE
7%
ESCHERICHIA URINARY TRACT INFECTION
7%
PNEUMONIA
7%
TOOTHACHE
7%
CONSTIPATION
7%
NECK PAIN
7%
ABDOMINAL PAIN
7%
FLATULENCE
7%
PERIPHERAL SWELLING
7%
LOWER RESPIRATORY TRACT INFECTION
7%
FALL
7%
ASPARTATE AMINOTRANSFERASE INCREASED
7%
BLOOD CREATININE INCREASED
7%
BLOOD LACTATE DEHYDROGENASE INCREASED
7%
HAEMOGLOBIN DECREASED
7%
MUSCLE SPASMS
7%
OROPHARYNGEAL PAIN
7%
HYPOTENSION
4%
INFLUENZA
4%
PNEUMONIA KLEBSIELLA
4%
BRADYCARDIA
4%
SCIATICA
4%
TOOTH ABSCESS
4%
SQUAMOUS CELL CARCINOMA OF SKIN
4%
BACTERAEMIA
4%
BRONCHOPULMONARY ASPERGILLOSIS
4%
RECTAL HAEMORRHAGE
4%
TUMOUR LYSIS SYNDROME
4%
LUMBAR SPINAL STENOSIS
4%
ACUTE KIDNEY INJURY
4%
LYMPHADENOPATHY
4%
SKIN INFECTION
4%
PRODUCTIVE COUGH
4%
HYPERGLYCAEMIA
4%
TRANSIENT ISCHEMIC ATTACK
4%
SMALL INTESTINAL OBSTRUCTION
4%
DRY MOUTH
4%
SEASONAL ALLERGY
4%
WEIGHT INCREASED
4%
FEBRILE NEUTROPENIA
4%
PANCYTOPENIA
4%
ACUTE MYOCARDIAL INFARCTION
4%
ANGINA PECTORIS
4%
CHOLELITHIASIS
4%
AMOEBIASIS
4%
ASPERGILLUS INFECTION
4%
CHRONIC LYMPHOCYTIC LEUKAEMIA
4%
PLEURAL EFFUSION
4%
GINGIVAL BLEEDING
4%
INFLUENZA LIKE ILLNESS
4%
PAIN
4%
HYPERBILIRUBINAEMIA
4%
CONJUNCTIVITIS
4%
HAEMOPHILUS INFECTION
4%
ORAL HERPES
4%
SINUSITIS
4%
STAPHYLOCOCCAL INFECTION
4%
MUSCULOSKELETAL PAIN
4%
BASAL CELL CARCINOMA
4%
COLORECTAL ADENOMA
4%
SKIN PAPILLOMA
4%
DYSGEUSIA
4%
LETHARGY
4%
NEUROPATHY PERIPHERAL
4%
AGITATION
4%
DYSURIA
4%
PROSTATITIS
4%
DYSPNOEA
4%
NIGHT SWEATS
4%
HAEMATOMA
4%
HYPERTENSION
4%
ESCHERICHIA BACTERAEMIA
4%
VIRAL INFECTION
4%
DYSPHAGIA
4%
FREQUENT BOWEL MOVEMENTS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Navitoclax 250 mg
Phase 2: Navitoclax 100 mg
Navitoclax 14/21 Day Cycle: 200 mg
Navitoclax 14/21 Day Cycle: 250 mg
Navitoclax 21/21 Day Cycle: 125 mg
Navitoclax 21/21 Day Cycle: 200 mg
Navitoclax 21/21 Day Cycle: 250 mg
Navitoclax 21/21 Day Cycle: 300 mg
Navitoclax 14/21 Day Cycle: 10 mg
Navitoclax 14/21 Day Cycle: 110 mg

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
1 Trials studying Lymphoid Malignancies
81 Patients Enrolled for Lymphoid Malignancies
AbbVieLead Sponsor
946 Previous Clinical Trials
496,443 Total Patients Enrolled
1 Trials studying Lymphoid Malignancies
37 Patients Enrolled for Lymphoid Malignancies
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,651 Total Patients Enrolled
1 Trials studying Lymphoid Malignancies
37 Patients Enrolled for Lymphoid Malignancies

Media Library

ABT-263 (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00788684 — Phase 1
Lymphoid Malignancies Research Study Groups: ABT-263 + rituximab
Lymphoid Malignancies 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this research endeavor?

"Unfortunately, no further patients are being sought for this trial. Initially posted on July 21st of 2009 and last edited June 3rd 2022, it is currently closed to new participants. However, there are 3529 studies recruiting individuals with lymphoma diffuse and 417 clinical trials seeking volunteers for ABT-263."

Answered by AI

How many distinct venues are managing this clinical experiment?

"This medical trial has been established in 4 different sites, such as the University of Arizona Cancer Center - North Campus /ID# 16721 in Tucson, Stanford University School of Med /ID# 9782 in Stanford and Univ of Wisconsin Hosp/Clinics /ID# 21701 in Madison."

Answered by AI

What medical afflictions has ABT-263 been documented to address?

"ABT-263 is a commonly used medicine for treating DLBCL and has shown promise in managing b-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI

What is the scope of participants receiving treatment in this experiment?

"At this moment, the recruitment for this clinical trial has closed. It was first listed on July 21st 2009 and last updated 3rd June 2022. If you are in search of other trials, 3529 medical studies recruiting patients with diffuse lymphoma and 417 looking to enrol ABT-263 subjects remain active presently."

Answered by AI

Has the Food & Drug Administration greenlit ABT-263?

"With limited data affirming ABT-263's efficacy and safety, our team at Power estimated its risk level to be 1 on a scale of one to three."

Answered by AI

What has been revealed through additional research of ABT-263?

"ABT-263 was first evaluated in 1993 at the NIH Clinical Center, 9000 Rockville Pike. Since then there have been 820 successful studies and 417 that are still recruiting participants - many of which take place at medical centers located in Tucson, Arizona."

Answered by AI

How may I become involved in this particular clinical investigation?

"Eligible applicants must possess diffuse lymphoma and be between the ages of 18-99. This medical experiment is looking to recruit a total of 29 participants."

Answered by AI

Is the age-range for this trial limited to individuals below 20 years old?

"This trial seeks to enrol individuals aged 18-99. For those under 18, there are 665 prospective studies while 3,552 exist for seniors over 65 years old."

Answered by AI
~0 spots leftby May 2024