Trial Outcomes & Findings for T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies (NCT NCT00683046)
NCT ID: NCT00683046
Last Updated: 2016-11-22
Results Overview
All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
Results posted on
2016-11-22
Participant Flow
Participant milestones
| Measure |
T-cell Depleted Allogeneic Stem Cell Transplantation
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
|
|---|---|
|
Overall Study
STARTED
|
204
|
|
Overall Study
COMPLETED
|
204
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
T-cell Depleted Allogeneic Stem Cell Transplantation
n=204 Participants
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
|
|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 yearsAll patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Outcome measures
| Measure |
T-cell Depleted Allogeneic Stem Cell Transplantation
n=204 Participants
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
|
|---|---|
|
Median Disease-free Survival
|
333 Days
Interval 253.0 to 386.0
|
SECONDARY outcome
Timeframe: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 yearsAll patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Outcome measures
| Measure |
T-cell Depleted Allogeneic Stem Cell Transplantation
n=204 Participants
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
|
|---|---|
|
Median Overall Survival
|
547 Days
Interval 378.0 to 946.0
|
Adverse Events
T-cell Depleted Allogeneic Stem Cell Transplantation
Serious events: 69 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T-cell Depleted Allogeneic Stem Cell Transplantation
n=204 participants at risk
All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3
|
|---|---|
|
Infections and infestations
Abdomial infection
|
0.98%
2/204 • 180 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.49%
1/204 • 180 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
1/204 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory distress syndrome
|
3.9%
8/204 • 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
2/204 • 180 days
|
|
Infections and infestations
Bladder infection
|
0.49%
1/204 • 180 days
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders, other
|
0.98%
2/204 • 180 days
|
|
Infections and infestations
Bone infection
|
0.49%
1/204 • 180 days
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
0.49%
1/204 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.49%
1/204 • 180 days
|
|
Infections and infestations
Catheter related infection
|
2.5%
5/204 • 180 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.49%
1/204 • 180 days
|
|
Nervous system disorders
Cognitive disturbance
|
0.49%
1/204 • 180 days
|
|
Gastrointestinal disorders
Colitis
|
0.98%
2/204 • 180 days
|
|
Psychiatric disorders
Confusion
|
0.98%
2/204 • 180 days
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
3/204 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.98%
2/204 • 180 days
|
|
Nervous system disorders
Encephalopathy
|
0.49%
1/204 • 180 days
|
|
Cardiac disorders
Endocarditis infective
|
0.49%
1/204 • 180 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
3/204 • 180 days
|
|
General disorders
Fever
|
0.49%
1/204 • 180 days
|
|
Cardiac disorders
Heart Failure
|
0.98%
2/204 • 180 days
|
|
Hepatobiliary disorders
Hepatic failure
|
1.5%
3/204 • 180 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.49%
1/204 • 180 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.49%
1/204 • 180 days
|
|
Infections and infestations
Infection and infestations - other, specify
|
11.3%
23/204 • 180 days
|
|
Infections and infestations
Pharyngitis
|
0.49%
1/204 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
3/204 • 180 days
|
|
Injury, poisoning and procedural complications
Post operative hemorrhage
|
0.49%
1/204 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.98%
2/204 • 180 days
|
|
Eye disorders
Retinal detachment
|
0.49%
1/204 • 180 days
|
|
Infections and infestations
Sepsis
|
5.4%
11/204 • 180 days
|
|
Infections and infestations
Skin infection
|
0.49%
1/204 • 180 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.49%
1/204 • 180 days
|
|
General disorders
Syncope
|
0.49%
1/204 • 180 days
|
|
Vascular disorders
Thromboembolic event
|
1.5%
3/204 • 180 days
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.0%
4/204 • 180 days
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.49%
1/204 • 180 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.49%
1/204 • 180 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place