Trial Outcomes & Findings for Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia (NCT NCT00623935)
NCT ID: NCT00623935
Last Updated: 2016-04-08
Results Overview
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals \> 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
1 year
Results posted on
2016-04-08
Participant Flow
Participant milestones
| Measure |
Fludarabine Plus Busulfan
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Fludarabine Plus Busulfan
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Patient Declined Transplant
|
1
|
Baseline Characteristics
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Fludarabine Plus Busulfan
n=56 Participants
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals \> 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
Outcome measures
| Measure |
Fludarabine Plus Busulfan
n=50 Participants
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Percentage of Participants With Relapse Free Survival at 1 Year
|
56 percentage of participants
Interval 43.0 to 69.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).
One of the secondary objectives was to determine overall survival for patients \> 55 years in age with AML undergoing full or reduced transplant with the best available donor.
Outcome measures
| Measure |
Fludarabine Plus Busulfan
n=50 Participants
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Percentage of Participants Alive at 1 Year
|
58 percentage of participants
Interval 46.0 to 74.0
|
Adverse Events
Fludarabine Plus Busulfan
Serious events: 21 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fludarabine Plus Busulfan
n=56 participants at risk
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Fever
|
5.4%
3/56 • Number of events 4
|
|
General disorders
Death not associated with CTCAE term
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
5.4%
3/56 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
2/56 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
5.4%
3/56 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/56 • Number of events 2
|
|
Vascular disorders
Hematoma
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Febrile neutropenia
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Blood Infection
|
1.8%
1/56 • Number of events 2
|
|
Infections and infestations
Soft Tissue Infection
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Infection - Other
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Confusion
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
Mental status
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Seizure
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
3.6%
2/56 • Number of events 2
|
|
Gastrointestinal disorders
Abdomen Pain
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Chest/Thorax Pain
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Syndromes - Other
|
1.8%
1/56 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
3.6%
2/56 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.8%
1/56 • Number of events 1
|
Other adverse events
| Measure |
Fludarabine Plus Busulfan
n=56 participants at risk
Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)
Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.
Patients will undergo an allogeneic stem cell transplant from related or unrelated donor.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
8.9%
5/56 • Number of events 6
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
8.9%
5/56 • Number of events 5
|
|
Infections and infestations
Infection
|
7.1%
4/56 • Number of events 7
|
|
Infections and infestations
Blood Infection
|
7.1%
4/56 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
4/56 • Number of events 6
|
|
Vascular disorders
Thrombosis (vascular access related)
|
7.1%
4/56 • Number of events 5
|
Additional Information
Dr. Gregory Yanik, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place