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BCL-2 Inhibitor

ABT-199 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for approximately 5 days following a single dose of abt-199.
Awards & highlights

Study Summary

This trial is testing if a new drug is safe and works when used with other drugs to treat leukemia. There is also a part of the trial testing how the new drug interacts with another drug.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for approximately 5 days following a single dose of abt-199.
This trial's timeline: 3 weeks for screening, Varies for treatment, and for approximately 5 days following a single dose of abt-199. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearance (CL)
Complete Remission Rate
Complete Remission with incomplete blood count recovery rate
+7 more
Secondary outcome measures
Duration of Response
Event Free Survival

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%
SYNCOPE
6%
RENAL FAILURE ACUTE
6%
FAILURE TO THRIVE
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%
POST HERPETIC NEURALGIA
3%
SINUSITIS
3%
PRESYNCOPE
3%
MUSCULAR WEAKNESS
3%
SCROTAL PAIN
3%
PAIN IN JAW
3%
ENTEROCOCCAL BACTERAEMIA
3%
LEPTOTRICHIA INFECTION
3%
PHARYNGITIS
3%
ACUTE MYELOID LEUKAEMIA
3%
MALIGNANT PLEURAL EFFUSION
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

3Treatment groups
Experimental Treatment
Group I: ABT-199+Decitabine+PosaconazoleExperimental Treatment3 Interventions
Treatment Naive Acute Myelogenous Leukemia
Group II: ABT-199 + DecitabineExperimental Treatment2 Interventions
Treatment Naive Acute Myelogenous Leukemia
Group III: ABT-199 + AzacitidineExperimental Treatment2 Interventions
Treatment Naive Acute Myelogenous Leukemia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Posaconazole
2018
Completed Phase 4
~4080
Azacitidine
2012
Completed Phase 3
~1440
ABT-199
2013
Completed Phase 2
~550
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,183 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,717 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,897 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
BloodJournal
Venetoclax Combined with Decitabine or Azacitidine in Treatment-naive, Elderly Patients with Acute Myeloid Leukemia
DiNardo, Courtney D., Keith Pratz, Vinod Pullarkat, Brian A. Jonas, Martha Arellano, Pamela S. Becker, Olga Frankfurt, et al.. 2019. “Venetoclax Combined with Decitabine or Azacitidine in Treatment-naive, Elderly Patients with Acute Myeloid Leukemia”. Blood. American Society of Hematology. doi:10.1182/blood-2018-08-868752.
Clinical Drug InvestigationJournal
Bioavailability Evaluation of Venetoclax Lower-strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 Mg Tablet
Badawi, Mohamed, Xin Chen, Patrick Marroum, Ahmed A. Suleiman, Sven Mensing, Anette Koenigsdorfer, Julia Teresa Schiele, et al.. 2022. “Bioavailability Evaluation of Venetoclax Lower-strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 Mg Tablet”. Clinical Drug Investigation. Springer Science and Business Media LLC. doi:10.1007/s40261-022-01172-4.
fJournal
Impact of <i>f</i> <i>lt3</i> Mutation on Outcomes After Venetoclax and Azacitidine for Patients with Treatment-naïve Acute Myeloid Leukemia
Konopleva, Marina, Michael J. Thirman, Keith W. Pratz, Jacqueline S. Garcia, Christian Recher, Vinod Pullarkat, Hagop M. Kantarjian, et al.. 2022. “Impact of f lt3 Mutation on Outcomes After Venetoclax and Azacitidine for Patients with Treatment-naïve Acute Myeloid Leukemia”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-3405.
idh1/2Journal
Impact of Venetoclax and Azacitidine in Treatment-naïve Patients with Acute Myeloid Leukemia and <i>idh1/2</i> Mutations
Pollyea, Daniel A., Courtney D. DiNardo, Martha L. Arellano, Arnaud Pigneux, Walter Fiedler, Marina Konopleva, David A. Rizzieri, et al.. 2022. “Impact of Venetoclax and Azacitidine in Treatment-naïve Patients with Acute Myeloid Leukemia and idh1/2 Mutations”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-3467.
~20 spots leftby Apr 2025
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