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BCL-2 Inhibitor

ABT-199 for B-Cell Lymphoma

Phase 1
Waitlist Available
Led By Andre Goy, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG (Eastern Cooperative Oncology Group) Performance Status </= 2.
Histologically or cytologically confirmed diagnosis of advanced DLBCL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs for people with a specific kind of cancer that has come back or hasn't responded to other treatments. The hypothesis is that this new combination will be more effective with fewer side effects than other treatments.

Eligible Conditions
  • B-Cell Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Efficacy as assessed by overall survival (OS)
Efficacy as assessed by progression free survival (PFS)
Incidence of treatment-emergent adverse events.

Side effects data

From 2014 Phase 2 trial • 32 Patients • NCT01994837
59%
NAUSEA
53%
DIARRHOEA
41%
VOMITING
38%
HYPOKALAEMIA
34%
FATIGUE
34%
HYPOMAGNESAEMIA
34%
HEADACHE
31%
HYPOPHOSPHATAEMIA
28%
COUGH
28%
FEBRILE NEUTROPENIA
25%
MALIGNANT NEOPLASM PROGRESSION
25%
EPISTAXIS
25%
OEDEMA PERIPHERAL
25%
HYPERPHOSPHATAEMIA
25%
HYPOCALCAEMIA
22%
ABDOMINAL PAIN
22%
DYSPNOEA
19%
PYREXIA
16%
INSOMNIA
16%
PNEUMONIA
16%
HYPOTENSION
13%
ANAEMIA
13%
SINUS TACHYCARDIA
13%
CONSTIPATION
13%
NON-CARDIAC CHEST PAIN
13%
ASPARTATE AMINOTRANSFERASE INCREASED
13%
BLOOD BILIRUBIN INCREASED
13%
DECREASED APPETITE
13%
HYPERGLYCAEMIA
13%
HYPOALBUMINAEMIA
13%
ARTHRALGIA
13%
OROPHARYNGEAL PAIN
13%
RASH MACULO-PAPULAR
13%
HYPERTENSION
9%
DYSPEPSIA
9%
ANXIETY
9%
DELIRIUM
9%
HAEMOGLOBINURIA
9%
ATRIAL FIBRILLATION
9%
HAEMORRHOIDS
9%
MALAISE
9%
CONJUNCTIVITIS
9%
URINARY TRACT INFECTION
9%
FALL
9%
ALANINE AMINOTRANSFERASE INCREASED
9%
BLOOD ALKALINE PHOSPHATASE INCREASED
9%
HYPERKALAEMIA
9%
HYPERMAGNESAEMIA
9%
HYPONATRAEMIA
9%
BACK PAIN
6%
FAILURE TO THRIVE
6%
SYNCOPE
6%
RENAL FAILURE ACUTE
6%
GINGIVAL BLEEDING
6%
TREMOR
6%
SINUS BRADYCARDIA
6%
EAR PAIN
6%
ABDOMINAL DISTENSION
6%
WEIGHT DECREASED
6%
WEIGHT INCREASED
6%
DEPRESSION
6%
SEPSIS
6%
STOMATITIS
6%
ASTHENIA
6%
CHILLS
6%
UPPER RESPIRATORY TRACT INFECTION
6%
CONTUSION
6%
LACERATION
6%
BLOOD CREATININE INCREASED
6%
ELECTROCARDIOGRAM QT PROLONGED
6%
WHITE BLOOD CELL COUNT DECREASED
6%
FLUID OVERLOAD
6%
HYPERURICAEMIA
6%
PAIN IN EXTREMITY
6%
DIZZINESS
6%
DYSGEUSIA
6%
HYPOXIA
6%
NASAL CONGESTION
6%
PLEURAL EFFUSION
6%
PNEUMONIA ASPIRATION
6%
PRURITUS
6%
CANDIDA INFECTION
6%
PURPURA
3%
ENTEROCOCCAL BACTERAEMIA
3%
LEPTOTRICHIA INFECTION
3%
PHARYNGITIS
3%
SINUSITIS
3%
MUSCULAR WEAKNESS
3%
PAIN IN JAW
3%
ACUTE MYELOID LEUKAEMIA
3%
MALIGNANT PLEURAL EFFUSION
3%
POST HERPETIC NEURALGIA
3%
PRESYNCOPE
3%
SCROTAL PAIN
3%
RHINORRHOEA
3%
DEATH
3%
CELLULITIS
3%
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
3%
DEVICE RELATED INFECTION
3%
CARDIAC FAILURE CONGESTIVE
3%
HYDROCELE
3%
CROHN'S DISEASE
3%
INTRA-ABDOMINAL HAEMORRHAGE
3%
MESENTERITIS
3%
BACTERAEMIA
3%
PNEUMONIA FUNGAL
3%
PSEUDOMONAL BACTERAEMIA
3%
PSEUDOMONAS INFECTION
3%
SEPTIC SHOCK
3%
VIRAL PHARYNGITIS
3%
VULVAL CELLULITIS
3%
DEHYDRATION
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABT-199

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABT-199 Plus Ibrutinib and RituximabExperimental Treatment3 Interventions
Cycle length will be 28 days. Venetoclax will be administered orally QD (Once Daily), continuously for 24 cycles. Ibrutinib will be administered orally QD, continuously for 24 cycles. Rituximab will be administered IV per institutional standards. weekly X 4 (Cycle 1); once on Day 1 of cycles 2-6 only, then every other cycle until Cycle 24 (total 18 doses of Rituxan from C1D1), Commercially available rituximab IV will be used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABT-199
2013
Completed Phase 2
~550
Ibrutinib
2014
Completed Phase 3
~1880
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,234 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
157 Previous Clinical Trials
579,662 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,670 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~1 spots leftby Mar 2025