Trial Outcomes & Findings for Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT00814164)

Last Updated: 2016-08-17

Results Overview

Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of \< 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease \[imaging required only if obtained pretreatment for known site(s) of disease\]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

2 years

Results posted on

2016-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Clorafarbine With Daunorubicin Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Overall Study STARTED	21
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Clorafarbine With Daunorubicin Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Overall Study Progression	7
Overall Study not stated	7
Overall Study Death	5

Baseline Characteristics

Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clorafarbine With Daunorubicin n=21 Participants Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Age, Continuous	70.6 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All treated and eligible patients

Outcome measures

Outcome measures
Measure	Clorafarbine With Daunorubicin n=21 Participants Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Complete Remission (CR)	38.1 percentage of participant Interval 20.8 to 59.1

SECONDARY outcome

Timeframe: 5 years

Population: All treated and eligible patients who had first objective documentation of CR or CRp.

Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Clorafarbine With Daunorubicin n=8 Participants Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Disease-free Survival	6.8 months Interval 1.1 to 36.3

SECONDARY outcome

Timeframe: 4 years

Population: All treated and eligible patients

Overall survival was defined as time from date of treatment initiation until date of death due to any cause.

Outcome measures

Outcome measures
Measure	Clorafarbine With Daunorubicin n=21 Participants Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Overall Survival	11.2 months Interval 4.2 to 14.2

Adverse Events

Clorafarbine With Daunorubicin

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clorafarbine With Daunorubicin n=21 participants at risk Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Gastrointestinal disorders Gastrointestinal haemorrhage	4.8% 1/21 • Number of events 2
General disorders Multi-organ failure	4.8% 1/21 • Number of events 1
Infections and infestations Cellulitis	4.8% 1/21 • Number of events 1
Infections and infestations Infection	4.8% 1/21 • Number of events 2
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1
Nervous system disorders Toxic encephalopathy	4.8% 1/21 • Number of events 1

Other adverse events

Other adverse events
Measure	Clorafarbine With Daunorubicin n=21 participants at risk Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. clofarabine: IV daunorubicin hydrochloride: IV cytogenetic analysis: Correlative study protein expression analysis: Correlative Study immunologic technique: Correlative Study pharmacological study: Correlative Study
Blood and lymphatic system disorders Anaemia	14.3% 3/21 • Number of events 3
Blood and lymphatic system disorders Febrile neutropenia	23.8% 5/21 • Number of events 6
Blood and lymphatic system disorders Leukopenia	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders Lymphadenopathy	4.8% 1/21 • Number of events 1
Blood and lymphatic system disorders Neutropenia	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders Thrombocytopenia	14.3% 3/21 • Number of events 3
Cardiac disorders Cardiac failure congestive	9.5% 2/21 • Number of events 2
Cardiac disorders Tachycardia	14.3% 3/21 • Number of events 3
Ear and labyrinth disorders Ear congestion	4.8% 1/21 • Number of events 1
Ear and labyrinth disorders Haematotympanum	4.8% 1/21 • Number of events 1
Ear and labyrinth disorders Vertigo	4.8% 1/21 • Number of events 1
Endocrine disorders Adrenal insufficiency	4.8% 1/21 • Number of events 1
Eye disorders Eye pain	4.8% 1/21 • Number of events 1
Eye disorders Ocular icterus	4.8% 1/21 • Number of events 1
Eye disorders Vision blurred	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Abdominal discomfort	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Abdominal distension	9.5% 2/21 • Number of events 2
Gastrointestinal disorders Ascites	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Cheilitis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Colitis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Constipation	33.3% 7/21 • Number of events 7
Gastrointestinal disorders Diarrhoea	76.2% 16/21 • Number of events 20
Gastrointestinal disorders Dry mouth	23.8% 5/21 • Number of events 5
Gastrointestinal disorders Dysphagia	9.5% 2/21 • Number of events 2
Gastrointestinal disorders Gastritis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Gingivitis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Haemorrhoids	9.5% 2/21 • Number of events 2
Gastrointestinal disorders Lip dry	14.3% 3/21 • Number of events 3
Gastrointestinal disorders Mouth haemorrhage	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Nausea	57.1% 12/21 • Number of events 14
Gastrointestinal disorders Proctitis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Retching	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Small intestinal obstruction	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Vomiting	28.6% 6/21 • Number of events 9
General disorders Asthenia	14.3% 3/21 • Number of events 3
General disorders Chills	4.8% 1/21 • Number of events 1
General disorders Fatigue	23.8% 5/21 • Number of events 5
General disorders Infusion site haemorrhage	4.8% 1/21 • Number of events 1
General disorders Mucosal inflammation	33.3% 7/21 • Number of events 8
General disorders Oedema peripheral	52.4% 11/21 • Number of events 12
General disorders Pain	23.8% 5/21 • Number of events 5
General disorders Pneumatosis	9.5% 2/21 • Number of events 2
General disorders Pyrexia	42.9% 9/21 • Number of events 11
Hepatobiliary disorders Hyperbilirubinaemia	42.9% 9/21 • Number of events 10
Immune system disorders Hypersensitivity	4.8% 1/21 • Number of events 1
Infections and infestations Bacteraemia	19.0% 4/21 • Number of events 4
Infections and infestations Candidiasis	19.0% 4/21 • Number of events 5
Infections and infestations Cellulitis	19.0% 4/21 • Number of events 4
Infections and infestations Cellulitis orbital	4.8% 1/21 • Number of events 1
Infections and infestations Endocarditis	4.8% 1/21 • Number of events 1
Infections and infestations Fungal skin infection	4.8% 1/21 • Number of events 1
Infections and infestations Infection	9.5% 2/21 • Number of events 3
Infections and infestations Infection in an immunocompromised host	4.8% 1/21 • Number of events 1
Infections and infestations Oral candidiasis	4.8% 1/21 • Number of events 1
Infections and infestations Oral herpes	9.5% 2/21 • Number of events 2
Infections and infestations Pneumonia	19.0% 4/21 • Number of events 4
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1
Injury, poisoning and procedural complications Contusion	14.3% 3/21 • Number of events 3
Injury, poisoning and procedural complications Excoriation	4.8% 1/21 • Number of events 1
Investigations Alanine aminotransferase increased	14.3% 3/21 • Number of events 3
Investigations Aspartate aminotransferase increased	23.8% 5/21 • Number of events 5
Investigations Blood alkaline phosphatase increased	9.5% 2/21 • Number of events 2
Investigations Blood bilirubin increased	4.8% 1/21 • Number of events 1
Investigations Blood creatinine increased	9.5% 2/21 • Number of events 2
Investigations Prothrombin time prolonged	4.8% 1/21 • Number of events 1
Investigations Transaminases increased	4.8% 1/21 • Number of events 1
Investigations Weight decreased	4.8% 1/21 • Number of events 1
Investigations Weight increased	4.8% 1/21 • Number of events 2
Metabolism and nutrition disorders Decreased appetite	23.8% 5/21 • Number of events 5
Metabolism and nutrition disorders Fluid overload	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Hyperglycaemia	14.3% 3/21 • Number of events 3
Metabolism and nutrition disorders Hyperphosphataemia	23.8% 5/21 • Number of events 5
Metabolism and nutrition disorders Hypoalbuminaemia	23.8% 5/21 • Number of events 5
Metabolism and nutrition disorders Hypocalcaemia	14.3% 3/21 • Number of events 3
Metabolism and nutrition disorders Hypokalaemia	23.8% 5/21 • Number of events 7
Metabolism and nutrition disorders Hypomagnesaemia	9.5% 2/21 • Number of events 4
Metabolism and nutrition disorders Hyponatraemia	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Hypophosphataemia	9.5% 2/21 • Number of events 2
Metabolism and nutrition disorders Tumour lysis syndrome	9.5% 2/21 • Number of events 2
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 2/21 • Number of events 3
Musculoskeletal and connective tissue disorders Back pain	4.8% 1/21 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 1/21 • Number of events 2
Musculoskeletal and connective tissue disorders Rhabdomyolysis	4.8% 1/21 • Number of events 1
Musculoskeletal and connective tissue disorders Soft tissue necrosis	4.8% 1/21 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	4.8% 1/21 • Number of events 1
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 1
Nervous system disorders Headache	23.8% 5/21 • Number of events 5
Nervous system disorders Lethargy	23.8% 5/21 • Number of events 5
Nervous system disorders Restless legs syndrome	4.8% 1/21 • Number of events 1
Nervous system disorders Sinus headache	4.8% 1/21 • Number of events 1
Nervous system disorders Somnolence	9.5% 2/21 • Number of events 2
Nervous system disorders Syncope	4.8% 1/21 • Number of events 1
Psychiatric disorders Agitation	9.5% 2/21 • Number of events 2
Psychiatric disorders Anxiety	23.8% 5/21 • Number of events 5
Psychiatric disorders Confusional state	19.0% 4/21 • Number of events 4
Psychiatric disorders Depression	4.8% 1/21 • Number of events 1
Psychiatric disorders Insomnia	33.3% 7/21 • Number of events 8
Psychiatric disorders Mental status changes	4.8% 1/21 • Number of events 1
Renal and urinary disorders Haematuria	28.6% 6/21 • Number of events 6
Renal and urinary disorders Micturition urgency	4.8% 1/21 • Number of events 1
Renal and urinary disorders Nocturia	9.5% 2/21 • Number of events 2
Renal and urinary disorders Pollakiuria	4.8% 1/21 • Number of events 1
Renal and urinary disorders Renal failure	19.0% 4/21 • Number of events 4
Renal and urinary disorders Renal mass	4.8% 1/21 • Number of events 1
Renal and urinary disorders Urinary retention	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	14.3% 3/21 • Number of events 4
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 7/21 • Number of events 7
Respiratory, thoracic and mediastinal disorders Haemoptysis	14.3% 3/21 • Number of events 3
Respiratory, thoracic and mediastinal disorders Hypoxia	9.5% 2/21 • Number of events 3
Respiratory, thoracic and mediastinal disorders Nasal dryness	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural effusion	19.0% 4/21 • Number of events 4
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	14.3% 3/21 • Number of events 3
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sinus congestion	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Wheezing	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Alopecia	52.4% 11/21 • Number of events 11
Skin and subcutaneous tissue disorders Blood blister	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Dry skin	9.5% 2/21 • Number of events 3
Skin and subcutaneous tissue disorders Ecchymosis	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Erythema	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Hyperhidrosis	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Hyperkeratosis	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	9.5% 2/21 • Number of events 2
Skin and subcutaneous tissue disorders Pruritus	14.3% 3/21 • Number of events 3
Skin and subcutaneous tissue disorders Purpura	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Rash	38.1% 8/21 • Number of events 8
Skin and subcutaneous tissue disorders Rash erythematous	23.8% 5/21 • Number of events 5
Skin and subcutaneous tissue disorders Rash follicular	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Rash generalised	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Rash macular	9.5% 2/21 • Number of events 2
Skin and subcutaneous tissue disorders Skin burning sensation	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Skin disorder	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Skin erosion	4.8% 1/21 • Number of events 1
Skin and subcutaneous tissue disorders Skin irritation	4.8% 1/21 • Number of events 1
Surgical and medical procedures Sinus operation	4.8% 1/21 • Number of events 1
Vascular disorders Flushing	14.3% 3/21 • Number of events 3
Vascular disorders Haematoma	14.3% 3/21 • Number of events 3
Vascular disorders Haemorrhage	14.3% 3/21 • Number of events 4
Vascular disorders Hypertension	19.0% 4/21 • Number of events 5
Vascular disorders Hypotension	14.3% 3/21 • Number of events 5
Vascular disorders Orthostatic hypotension	14.3% 3/21 • Number of events 3
Vascular disorders Pallor	9.5% 2/21 • Number of events 2
Vascular disorders Thrombosis	4.8% 1/21 • Number of events 1
Vascular disorders Varicose vein	4.8% 1/21 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place