Trial Outcomes & Findings for Busulfan and Fludarabine in Patients With AML and MDS (NCT NCT00502905)
NCT ID: NCT00502905
Last Updated: 2012-05-28
Results Overview
Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Study period one week prior to transplant through post Day 28
Results posted on
2012-05-28
Participant Flow
Recruitment Period: April 12, 2001 through July 14, 2005. All participants recruited at UT MD Anderson Cancer Center.
Of the 200 participants enrolled, four participants were excluded from the trial and did not receive treatment.
Participant milestones
| Measure |
Busulfan + Fludarabine
Busulfan 130 mg/m\^2 + Fludarabine 40 mg/m\^2 given daily for four days
|
|---|---|
|
Overall Study
STARTED
|
196
|
|
Overall Study
COMPLETED
|
196
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Busulfan and Fludarabine in Patients With AML and MDS
Baseline characteristics by cohort
| Measure |
Busulfan + Fludarabine
n=196 Participants
Busulfan 130 mg/m\^2 + Fludarabine 40 mg/m\^2 given daily for four days
|
|---|---|
|
Age Continuous
|
43 years
STANDARD_DEVIATION 13 • n=93 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
196 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Study period one week prior to transplant through post Day 28Population: Analysis per protocol.
Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.
Outcome measures
| Measure |
Busulfan + Fludarabine
n=196 Participants
Busulfan 130 mg/m\^2 + Fludarabine 40 mg/m\^2 given daily for four days
|
|---|---|
|
Number of Participants With Successful Engraftment
|
192 participants
|
Adverse Events
Busulfan + Fludarabine
Serious events: 68 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Busulfan + Fludarabine
n=196 participants at risk
Busulfan 130 mg/m\^2 + Fludarabine 40 mg/m\^2 given daily for four days
|
|---|---|
|
Cardiac disorders
Pericarditis
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
3.6%
7/196 • Number of events 7 • 7 years and 7 months
|
|
Nervous system disorders
Bell's Palsy
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Nervous system disorders
Altered Mental Status
|
2.0%
4/196 • Number of events 4 • 7 years and 7 months
|
|
General disorders
Graft vs Host Disease
|
7.7%
15/196 • Number of events 15 • 7 years and 7 months
|
|
General disorders
Fever
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.0%
4/196 • Number of events 4 • 7 years and 7 months
|
|
General disorders
Plasmapheresis
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Immune system disorders
Infection
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Renal and urinary disorders
Hematuria
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
|
Cardiac disorders
Cardiac Failure
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
General disorders
Death due to Relapse
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Cardiac disorders
Deep Vein Thrombosis
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Hepatobiliary disorders
Elevated serum glutamic oxaloacetic transaminase (SGOT)
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
General disorders
Ascites
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Nervous system disorders
Seizure
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Nervous system disorders
Dizziness
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
General disorders
Graft Failure
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
|
Gastrointestinal disorders
Mucositis
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Renal and urinary disorders
Renal Failure
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Hepatobiliary disorders
Cholecystectomy
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
Other adverse events
| Measure |
Busulfan + Fludarabine
n=196 participants at risk
Busulfan 130 mg/m\^2 + Fludarabine 40 mg/m\^2 given daily for four days
|
|---|---|
|
Immune system disorders
Allergy
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Blood and lymphatic system disorders
Neutrophils/Granulocytes
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Vascular disorders
Thrombosis/Thrombus
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Cardiac disorders
Hypertension
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Renal and urinary disorders
Hematuria
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Reproductive system and breast disorders
Vaginitis
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Renal and urinary disorders
Cystitis
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
|
Hepatobiliary disorders
Increased Alanine transaminase (ALT)
|
2.6%
5/196 • Number of events 5 • 7 years and 7 months
|
|
Hepatobiliary disorders
Veno-Occlusive Disease
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Infections and infestations
Infection
|
5.6%
11/196 • Number of events 11 • 7 years and 7 months
|
|
Nervous system disorders
Altered Mental Status
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Nervous system disorders
Seizure
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Eye disorders
Keratitis
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.0%
2/196 • Number of events 2 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.51%
1/196 • Number of events 1 • 7 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
1.5%
3/196 • Number of events 3 • 7 years and 7 months
|
Additional Information
Gabriela Rondon, MD / Assistant Professor
UT MD Anderson Cancer Center
Phone: 713 745-2294
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place