Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With Myelofibrosis (NCT NCT00245128)
NCT ID: NCT00245128
Last Updated: 2012-01-13
Results Overview
A major response = transfusion independent or a\>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks. Minor response= \> 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
At 3,6, and 12 months of therapy
Results posted on
2012-01-13
Participant Flow
Participant milestones
| Measure |
Imatinib Mesylate (Gleevec)
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imatinib Mesylate in Treating Patients With Myelofibrosis
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate (Gleevec)
n=10 Participants
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
68.2 years
STANDARD_DEVIATION 11.00303 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 3,6, and 12 months of therapyA major response = transfusion independent or a\>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks. Minor response= \> 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After 6 and 12 months of therapyOutcome measures
Outcome data not reported
Adverse Events
Imatinib Mesylate (Gleevec)
Serious events: 10 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib Mesylate (Gleevec)
n=10 participants at risk
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusions
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Sepsis
|
10.0%
1/10
|
|
General disorders
Fever
|
20.0%
2/10
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity Pneumonitis
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Spontaneous Abortion
|
20.0%
2/10
|
|
Blood and lymphatic system disorders
Elevated CPK
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
10.0%
1/10
|
|
Nervous system disorders
Parkinson's Disease
|
10.0%
1/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver abscess
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Acute leukemia
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10
|
|
Respiratory, thoracic and mediastinal disorders
Oesophageal adenocarcinoma
|
10.0%
1/10
|
|
Eye disorders
Optic nerve atrophy
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
hospitalization for bone pain
|
10.0%
1/10
|
|
Renal and urinary disorders
Oncocytoma
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Menorrhagia
|
10.0%
1/10
|
|
Nervous system disorders
Extra pyramidal symptoms
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
10.0%
1/10
|
|
Gastrointestinal disorders
Lower abdominal pain
|
10.0%
1/10
|
|
Renal and urinary disorders
Ureteric Calculus
|
10.0%
1/10
|
|
Infections and infestations
Bacterial meningitis
|
10.0%
1/10
|
|
Renal and urinary disorders
Bilirubin and lipase
|
10.0%
1/10
|
|
Vascular disorders
ateriovenus malformation
|
10.0%
1/10
|
|
Renal and urinary disorders
Cholelithiasis
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Esophageal fistula
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Hodgkin's Disease
|
10.0%
1/10
|
|
Eye disorders
Retinal detachment
|
10.0%
1/10
|
|
Gastrointestinal disorders
Fatal diverticulitis, gastrointestinal peforation, peritonitis
|
10.0%
1/10
|
|
Gastrointestinal disorders
Fatal pancreatitis
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Prostate Cancer
|
10.0%
1/10
|
|
Renal and urinary disorders
Hydronephrosis
|
10.0%
1/10
|
|
Eye disorders
Ptosis
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
10.0%
1/10
|
|
General disorders
Death
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10
|
|
Nervous system disorders
Brain herniation
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Priapism
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Squamous cell carcinoma of the penis
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Leydig cell hyperplasia
|
10.0%
1/10
|
|
Renal and urinary disorders
Urothelial Carcinoma
|
10.0%
1/10
|
|
Nervous system disorders
Bell's Palsy
|
10.0%
1/10
|
|
Nervous system disorders
Plaques of demyelination
|
10.0%
1/10
|
|
Renal and urinary disorders
Interstitial nephritis
|
10.0%
1/10
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Metastases of breast cancer
|
10.0%
1/10
|
Other adverse events
| Measure |
Imatinib Mesylate (Gleevec)
n=10 participants at risk
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place