Trial Outcomes & Findings for Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT00673153)

NCT ID: NCT00673153

Last Updated: 2017-06-01

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

after completion of induction therapy, administered every 21-42 days for up to two courses

Results posted on

2017-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=31 Participants REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Age, Continuous	72 years n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants
Region of Enrollment United States	31 participants n=99 Participants
Risk Group Poor-risk Group	10 Participants n=99 Participants
Risk Group Good-risk Group	21 Participants n=99 Participants

PRIMARY outcome

Timeframe: after completion of induction therapy, administered every 21-42 days for up to two courses

Population: Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1

Outcome measures

Outcome measures
Measure	Arm I n=21 Participants REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Number of Participants Achieving CR or CRi With Induction Therapy (Good-risk Group)	6 Participants

PRIMARY outcome

Timeframe: At day 30

Population: Poor-risk Group: patients aged ≥70 years and performance status 2-3

Outcome measures

Outcome measures
Measure	Arm I n=10 Participants REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Number of Participants Alive at Day 30 (Poor-risk Group)	8 Participants

SECONDARY outcome

Timeframe: At relapse

Population: Poor-risk Group: patients aged ≥70 years and performance status 2-3; Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1

Outcome measures

Outcome measures
Measure	Arm I n=31 Participants REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Relapse-free Survival (Good- and Poor-risk Group)	7 Participants

SECONDARY outcome

Timeframe: after completion of induction therapy, administered every 21-42 days for up to two courses

Population: Poor-risk Group: patients aged ≥70 years and performance status 2-3

Outcome measures

Outcome measures
Measure	Arm I n=10 Participants REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Number of Participants Achieving CR or CRi With Induction Therapy (Poor-risk Group)	1 Participants

SECONDARY outcome

Timeframe: At day 30

Population: Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1

Outcome measures

Outcome measures
Measure	Arm I n=21 Participants REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Number of Participants Alive at Day 30 (Good-risk Group)	20 Participants

Adverse Events

Arm I

Serious events: 12 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=31 participants at risk REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders GI Bleed	3.2% 1/31 • Number of events 1
Infections and infestations Pneumonia	6.5% 2/31 • Number of events 2
General disorders Death	12.9% 4/31 • Number of events 4
Infections and infestations Neutropenic Fever	16.1% 5/31 • Number of events 5
Injury, poisoning and procedural complications Fall	3.2% 1/31 • Number of events 1
Surgical and medical procedures Bleeding at PICC site	3.2% 1/31 • Number of events 1
Skin and subcutaneous tissue disorders Perirectal cellulitis	3.2% 1/31 • Number of events 1
Infections and infestations Septic Shock	3.2% 1/31 • Number of events 1
Blood and lymphatic system disorders Epistaxis	3.2% 1/31 • Number of events 1
Infections and infestations E-coli Infection	3.2% 1/31 • Number of events 1

Other adverse events

Other adverse events
Measure	Arm I n=31 participants at risk REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses. gemtuzumab ozogamicin: Given IV vorinostat: Given orally laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Neutropenia	61.3% 19/31 • Number of events 26
Infections and infestations Neutropenic Fever	22.6% 7/31 • Number of events 14
Blood and lymphatic system disorders Thrombocytopenia	58.1% 18/31 • Number of events 22
Blood and lymphatic system disorders Anemia	32.3% 10/31 • Number of events 10
Respiratory, thoracic and mediastinal disorders Cough	3.2% 1/31 • Number of events 1
General disorders Chills	9.7% 3/31 • Number of events 3
General disorders Fatigue	9.7% 3/31 • Number of events 3
Gastrointestinal disorders Nausea	6.5% 2/31 • Number of events 2
General disorders Edema/Swelling	6.5% 2/31 • Number of events 2
Gastrointestinal disorders Diarrhea	9.7% 3/31 • Number of events 4
Blood and lymphatic system disorders Hypokalemia	3.2% 1/31 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	12.9% 4/31 • Number of events 4
Nervous system disorders Headache	3.2% 1/31 • Number of events 1
Metabolism and nutrition disorders Anorexia	6.5% 2/31 • Number of events 2
Investigations Weight loss	6.5% 2/31 • Number of events 2
Musculoskeletal and connective tissue disorders Chest pain	6.5% 2/31 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dyspnea	6.5% 2/31 • Number of events 2
Respiratory, thoracic and mediastinal disorders Epistaxis	9.7% 3/31 • Number of events 3
Gastrointestinal disorders Gingival bleeding	3.2% 1/31 • Number of events 2
Gastrointestinal disorders Hemorrhoidal hemorrhage	3.2% 1/31 • Number of events 1
Gastrointestinal disorders Constipation	3.2% 1/31 • Number of events 2
Psychiatric disorders Confusion	6.5% 2/31 • Number of events 2
Investigations Creatinine increased	9.7% 3/31 • Number of events 3
Eye disorders Blurred Vision	3.2% 1/31 • Number of events 1
Musculoskeletal and connective tissue disorders Muscle Weakness	6.5% 2/31 • Number of events 2
Blood and lymphatic system disorders White blood cell decreased	6.5% 2/31 • Number of events 3
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pulmonary Nodules	3.2% 1/31 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	3.2% 1/31 • Number of events 1
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	3.2% 1/31 • Number of events 1
Renal and urinary disorders Increased urinary frequency	3.2% 1/31 • Number of events 1
Metabolism and nutrition disorders Diaphoresis	3.2% 1/31 • Number of events 1
General disorders Infusion related reaction	3.2% 1/31 • Number of events 1
Investigations Increased lactate dehydrogenase	3.2% 1/31 • Number of events 1
General disorders Malaise	3.2% 1/31 • Number of events 1
Vascular disorders Hematoma, scalp	3.2% 1/31 • Number of events 1
Gastrointestinal disorders Gastrointestinal Bleed	6.5% 2/31 • Number of events 2
Gastrointestinal disorders Appendix Fistula	3.2% 1/31 • Number of events 1
Blood and lymphatic system disorders Hemorrhage, post bone marrow	3.2% 1/31 • Number of events 1
Immune system disorders Streptococcus salivarius	3.2% 1/31 • Number of events 1
Infections and infestations Sepsis	3.2% 1/31 • Number of events 1
Infections and infestations Bacteremia	9.7% 3/31 • Number of events 3
Cardiac disorders Cardiac arrhythmia	6.5% 2/31 • Number of events 5
Cardiac disorders Heart Failure	3.2% 1/31 • Number of events 2
Vascular disorders Orthostatic hypotension	6.5% 2/31 • Number of events 2
Vascular disorders Hypertension	3.2% 1/31 • Number of events 1
Cardiac disorders Non-ST-elevation myocardial infarction	3.2% 1/31 • Number of events 1

Additional Information

Roland B. Walter, MD, PhD, MS

Fred Hutch Cancer Research Center

Phone: (206) 667-3599

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor CAN require changes to the communication and CAN extend the embargo.
Publication restrictions are in place

Restriction type: OTHER