Trial Outcomes & Findings for Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia (NCT NCT00096122)

Last Updated: 2014-05-26

Results Overview

Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

95 participants

Primary outcome timeframe

21 Day Cycle

Results posted on

2014-05-26

Participant Flow

Recruitment Period: 9/16/2004 to 9/22/2006. All patients registered at The University of Texas M.D. Anderson Cancer Center.

One participant enrolled was excluded from the study.

Participant milestones

Participant milestones
Measure	Idarubicin, Cytarabine + Tipifarnib Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Overall Study STARTED	95
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Idarubicin, Cytarabine + Tipifarnib n=95 Participants Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Age, Continuous	50 years n=99 Participants
Sex: Female, Male Female	53 Participants n=99 Participants
Sex: Female, Male Male	42 Participants n=99 Participants
Region of Enrollment United States	95 participants n=99 Participants

PRIMARY outcome

Timeframe: 21 Day Cycle

Population: Analysis was per protocol.

Outcome measures

Outcome measures
Measure	Idarubicin, Cytarabine + Tipifarnib n=95 Participants Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Number of Participants With Complete Response CR	61 Participants
Number of Participants With Complete Response CRp	9 Participants

Adverse Events

Idarubicin, Cytarabine + Tipifarnib

Serious events: 46 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Idarubicin, Cytarabine + Tipifarnib n=95 participants at risk Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Infections and infestations Infection	12.6% 12/95 • Number of events 14 • 5 years 4 months
Infections and infestations Febrile neutropenia	14.7% 14/95 • Number of events 21 • 5 years 4 months
Blood and lymphatic system disorders Thrombocytopenia	1.1% 1/95 • Number of events 1 • 5 years 4 months
Hepatobiliary disorders Hyperbilirubinemia	6.3% 6/95 • Number of events 6 • 5 years 4 months
General disorders Death	5.3% 5/95 • Number of events 5 • 5 years 4 months
Metabolism and nutrition disorders Hypokalemia	2.1% 2/95 • Number of events 2 • 5 years 4 months
Gastrointestinal disorders Enteritis	1.1% 1/95 • Number of events 1 • 5 years 4 months
Vascular disorders Hemorrhage	5.3% 5/95 • Number of events 5 • 5 years 4 months
Gastrointestinal disorders Typhilitis	1.1% 1/95 • Number of events 1 • 5 years 4 months
Gastrointestinal disorders Ileus	1.1% 1/95 • Number of events 1 • 5 years 4 months
Gastrointestinal disorders Esophagitis	1.1% 1/95 • Number of events 1 • 5 years 4 months
Cardiac disorders Decreased left ventricular ejection fraction (LVEF)	1.1% 1/95 • Number of events 1 • 5 years 4 months
Nervous system disorders Cognitive disturbance	1.1% 1/95 • Number of events 1 • 5 years 4 months
Gastrointestinal disorders Colitis	2.1% 2/95 • Number of events 2 • 5 years 4 months
Renal and urinary disorders Renal Failure	1.1% 1/95 • Number of events 1 • 5 years 4 months
Gastrointestinal disorders Nausea	1.1% 1/95 • Number of events 1 • 5 years 4 months
Gastrointestinal disorders Vomiting	1.1% 1/95 • Number of events 1 • 5 years 4 months
Gastrointestinal disorders Diarrhea	2.1% 2/95 • Number of events 2 • 5 years 4 months
General disorders Edema	1.1% 1/95 • Number of events 1 • 5 years 4 months
Respiratory, thoracic and mediastinal disorders Bilateral pleural effusions	1.1% 1/95 • Number of events 1 • 5 years 4 months
Nervous system disorders Seizure	1.1% 1/95 • Number of events 1 • 5 years 4 months
General disorders Pain	1.1% 1/95 • Number of events 1 • 5 years 4 months
Nervous system disorders Confusion	1.1% 1/95 • Number of events 1 • 5 years 4 months
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.1% 1/95 • Number of events 1 • 5 years 4 months

Other adverse events

Other adverse events
Measure	Idarubicin, Cytarabine + Tipifarnib n=95 participants at risk Cytarabine 1.5 g/m\^2 and Idarubicin 12 mg/m\^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Gastrointestinal disorders Diarrhea	69.5% 66/95 • Number of events 66 • 5 years 4 months
Gastrointestinal disorders Nausea/Vomiting	56.8% 54/95 • Number of events 54 • 5 years 4 months
Skin and subcutaneous tissue disorders Rash/Puritis	53.7% 51/95 • Number of events 51 • 5 years 4 months
Hepatobiliary disorders Hyperbilirubinemia	26.3% 25/95 • Number of events 25 • 5 years 4 months
Gastrointestinal disorders Mucositis	24.2% 23/95 • Number of events 23 • 5 years 4 months
General disorders Pain	28.4% 27/95 • Number of events 27 • 5 years 4 months
General disorders Fatigue	21.1% 20/95 • Number of events 20 • 5 years 4 months
Nervous system disorders Mood alteration	12.6% 12/95 • Number of events 12 • 5 years 4 months
Cardiac disorders Hypotension	12.6% 12/95 • Number of events 12 • 5 years 4 months
Metabolism and nutrition disorders Hypokalemia	12.6% 12/95 • Number of events 12 • 5 years 4 months
General disorders Edema	11.6% 11/95 • Number of events 11 • 5 years 4 months
Respiratory, thoracic and mediastinal disorders Dyspnea	9.5% 9/95 • Number of events 9 • 5 years 4 months
Gastrointestinal disorders Constipation	11.6% 11/95 • Number of events 11 • 5 years 4 months
Metabolism and nutrition disorders Hypoalbuminemia	10.5% 10/95 • Number of events 10 • 5 years 4 months
Metabolism and nutrition disorders Hyperglycemia	10.5% 10/95 • Number of events 10 • 5 years 4 months
Metabolism and nutrition disorders Hypophosphatemia	8.4% 8/95 • Number of events 8 • 5 years 4 months
Gastrointestinal disorders Anorexia	8.4% 8/95 • Number of events 8 • 5 years 4 months
Renal and urinary disorders Elevated creatinine	7.4% 7/95 • Number of events 7 • 5 years 4 months
Metabolism and nutrition disorders Hypocalcemia	6.3% 6/95 • Number of events 6 • 5 years 4 months

Additional Information

Jorge Cortes, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-745-5783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60