Trial Outcomes & Findings for Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers (NCT NCT00619645)
NCT ID: NCT00619645
Last Updated: 2018-01-10
Results Overview
Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 months after day 100 transplant
Results posted on
2018-01-10
Participant Flow
Participant milestones
| Measure |
RIST for Heme Malignancies
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RIST for Heme Malignancies
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers
Baseline characteristics by cohort
| Measure |
RIST for Heme Malignancies
n=8 Participants
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
59.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months after day 100 transplantPatients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.
Outcome measures
| Measure |
RIST for Heme Malignancies
n=8 Participants
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
|
|---|---|
|
Number of Patients With Day 100 Transplant-related Mortality
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 months after day 100 transplantPopulation: This outcome was not collected/analyzed
All patients will be followed for progression for 24 months after their day 100 transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post day 100 transplantPatients will be followed for survival for 24 months post day 100 transplant.
Outcome measures
| Measure |
RIST for Heme Malignancies
n=8 Participants
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
|
|---|---|
|
Number of Patients Alive 24 Months Post Day 100 Transplant
|
3 Participants
|
Adverse Events
RIST for Heme Malignancies
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RIST for Heme Malignancies
n=8 participants at risk
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
busulfan
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
62.5%
5/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
4/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
62.5%
5/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
blood bicarbonate decreased
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
constipation
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
diarrhea
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Nervous system disorders
dizziness
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Edema: head and neck
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Edema: trunk/genital
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
esophageal pain
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Eye disorders
Eye disorder
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Fatigue
|
87.5%
7/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Fatigue-lower mobility
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Fever
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • Adverse events were collected through Day 100 of treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
87.5%
7/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Hyperbilirubinemia
|
37.5%
3/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
4/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Cardiac disorders
Hypertension
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
75.0%
6/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • Adverse events were collected through Day 100 of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Leukocytes
|
75.0%
6/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Leukopenia
|
37.5%
3/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Lymphopenia
|
75.0%
6/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Mucositis
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Muscle weakness
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Myalgia
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Nervous system disorders
Myelitis
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Adverse events were collected through Day 100 of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Neutrophil count decreased
|
75.0%
6/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain-lower extremity
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
Petechia
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Investigations
Platelet count decreased
|
62.5%
5/8 • Adverse events were collected through Day 100 of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desuamating
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
2/8 • Adverse events were collected through Day 100 of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Taste alteration
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
|
General disorders
weight loss
|
12.5%
1/8 • Adverse events were collected through Day 100 of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place