Trial Outcomes & Findings for Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia (NCT NCT00528398)

Last Updated: 2017-02-06

Results Overview

The peripheral blood neutrophil count is \>= 1.5 x 10\^9 / L and platelets more than 100 x 10\^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

7 days post completion of induction chemotherapy

Results posted on

2017-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Idarubicin, Cytarabine) All patients were analyzed together.
Overall Study STARTED	111
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Idarubicin, Cytarabine) n=111 Participants All patients were analyzed together.
Age, Continuous	43 years n=99 Participants
Gender Female	50 Participants n=99 Participants
Gender Male	61 Participants n=99 Participants
Diagnosis De Novo AML	80 Participants n=99 Participants
Diagnosis AML Secondary to Chemotherapy	6 Participants n=99 Participants
Diagnosis AML Evolved from MDS	25 Participants n=99 Participants

PRIMARY outcome

Timeframe: 7 days post completion of induction chemotherapy

Outcome measures

Outcome measures
Measure	Treatment (Idarubicin, Cytarabine) n=111 Participants All patients were analyzed together.
Complete Remission (CR) CR	77 Participants
Complete Remission (CR) No CR	32 Participants
Complete Remission (CR) Unknown	2 Participants

SECONDARY outcome

Timeframe: 7 days post completion of induction chemotherapy

Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)

Outcome measures

Outcome measures
Measure	Treatment (Idarubicin, Cytarabine) n=111 Participants All patients were analyzed together.
Bone Marrow at Day 7 Post-Induction Chemotherapy Positive for Leukemia	17 Participants
Bone Marrow at Day 7 Post-Induction Chemotherapy Negative for Leukemia	90 Participants
Bone Marrow at Day 7 Post-Induction Chemotherapy Unknown	4 Participants

Adverse Events

Treatment (Idarubicin, Cytarabine)

Serious events: 51 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Idarubicin, Cytarabine) n=111 participants at risk All patients were analyzed together.
Infections and infestations Infection	3.6% 4/111 • Number of events 4
Skin and subcutaneous tissue disorders Skin	0.90% 1/111 • Number of events 1
Hepatobiliary disorders Liver	0.90% 1/111 • Number of events 1
Respiratory, thoracic and mediastinal disorders Lung	3.6% 4/111 • Number of events 4
Gastrointestinal disorders Nausea	2.7% 3/111 • Number of events 3
Gastrointestinal disorders Diarrhea	0.90% 1/111 • Number of events 1
General disorders Fever	18.0% 20/111 • Number of events 20
Musculoskeletal and connective tissue disorders Back Pain	1.8% 2/111 • Number of events 2
Nervous system disorders Headache	1.8% 2/111 • Number of events 2
Vascular disorders Hypertension	2.7% 3/111 • Number of events 3
Metabolism and nutrition disorders Hypocalcemia	1.8% 2/111 • Number of events 2
Metabolism and nutrition disorders Hypokalemia	0.90% 1/111 • Number of events 1
Vascular disorders Hypotension	0.90% 1/111 • Number of events 1
Blood and lymphatic system disorders Pancytopenia	9.0% 10/111 • Number of events 10
Investigations Edema/Anasarca	0.90% 1/111 • Number of events 1
Infections and infestations Gingivitis	0.90% 1/111 • Number of events 1
Hepatobiliary disorders Jaundice	0.90% 1/111 • Number of events 1
Gastrointestinal disorders Pancreatitis	0.90% 1/111 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	0.90% 1/111 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	0.90% 1/111 • Number of events 1
Musculoskeletal and connective tissue disorders Abdominal pain	1.8% 2/111 • Number of events 2
Nervous system disorders Paresthesia	0.90% 1/111 • Number of events 1
Musculoskeletal and connective tissue disorders Pleuritic Pain	0.90% 1/111 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Idarubicin, Cytarabine) n=111 participants at risk All patients were analyzed together.
Infections and infestations Infection	50.5% 56/111 • Number of events 56
Skin and subcutaneous tissue disorders Skin	63.1% 70/111 • Number of events 70
Gastrointestinal disorders Mucositis	38.7% 43/111 • Number of events 43
Renal and urinary disorders Renal	19.8% 22/111 • Number of events 22
Hepatobiliary disorders Liver	53.2% 59/111 • Number of events 59
Respiratory, thoracic and mediastinal disorders Lung	28.8% 32/111 • Number of events 32
Cardiac disorders Heart	14.4% 16/111 • Number of events 16
Gastrointestinal disorders Nausea	67.6% 75/111 • Number of events 75
Gastrointestinal disorders Vomiting	59.5% 66/111 • Number of events 66
Gastrointestinal disorders Diarrhea	59.5% 66/111 • Number of events 66
General disorders Fever	59.5% 66/111 • Number of events 66
Blood and lymphatic system disorders Hemorrhage	13.5% 15/111 • Number of events 15
Nervous system disorders Anxiety	9.0% 10/111 • Number of events 10
Nervous system disorders Headache	21.6% 24/111 • Number of events 24
General disorders Fatigue	5.4% 6/111 • Number of events 6
Psychiatric disorders Insomnia	8.1% 9/111 • Number of events 9
General disorders Chills	9.9% 11/111 • Number of events 11
General disorders Edema	7.2% 8/111 • Number of events 8
Metabolism and nutrition disorders Hypocalcemia	6.3% 7/111 • Number of events 7
Metabolism and nutrition disorders Hypokalemia	5.4% 6/111 • Number of events 6

Additional Information

Anthony Stein, M.D.

City of Hope National Medical Center

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place