Trial Outcomes & Findings for Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer (NCT NCT00027560)
NCT ID: NCT00027560
Last Updated: 2013-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
12 months post transplant
Results posted on
2013-01-07
Participant Flow
Protocol Open to Accrual 07/31/2001 Protocol Closed to Accrual 05/23/2006 Primary Completion Date 04/14/2009 Recruitment Location is medical clinic
Enrolled participants receive preparative cytoreduction prior to transplant.
Participant milestones
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
Baseline characteristics by cohort
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=51 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
42.9 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months post transplantPopulation: Population is defined as all participants who received transplant as per protocol.
Outcome measures
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=50 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Overall Survival
|
37 participants
|
PRIMARY outcome
Timeframe: 24 months post transplantPopulation: Population is defined as all participants who received transplant as per protocol.
Outcome measures
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=50 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Overall Survival
|
30 participants
|
PRIMARY outcome
Timeframe: up to 4 months post transplantPopulation: The number of matched related patients was analyzed as per protocol.
Grade III-IV Acute Graft-versus-Host Disease
Outcome measures
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=25 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Acute Graft-versus-Host Disease Matched Related Patients
|
1 participants
|
SECONDARY outcome
Timeframe: up to 4 months post transplantPopulation: The number of unrelated and mismatched patients was analyzed as per protocol.
Grade III-IV Acute Graft-versus-Host Disease
Outcome measures
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=25 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients
|
3 participants
|
SECONDARY outcome
Timeframe: up to 2 years post transplantPopulation: The number of matched related patients was analyzed as per protocol.
Outcome measures
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=25 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Extensive Chronic Graft-versus-Host Disease Matched Related Patients
|
0 participants
|
SECONDARY outcome
Timeframe: up to 2 years post transplantPopulation: The number of unrelated and mismatched patients was analyzed as per protocol.
Outcome measures
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=25 Participants
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients
|
2 participants
|
Adverse Events
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=50 participants at risk
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Infections and infestations
Infection with grade 3/4 neut
|
2.0%
1/50 • Number of events 1 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Infections and infestations
Infection w.out neutropenia
|
2.0%
1/50 • Number of events 1 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
General disorders
Constitut symp, other
|
2.0%
1/50 • Number of events 1 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
Other adverse events
| Measure |
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
n=50 participants at risk
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
|
|---|---|
|
Hepatobiliary disorders
SGOT (AST)
|
16.0%
8/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Hepatobiliary disorders
Bilirubin increased
|
24.0%
12/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Gastrointestinal disorders
Stomatitis/BMT
|
18.0%
9/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
16.0%
8/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Metabolism and nutrition disorders
Creatinine increased
|
64.0%
32/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
16.0%
8/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.0%
13/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Blood and lymphatic system disorders
Transfusion (PLT/BMT)
|
18.0%
9/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
|
Hepatobiliary disorders
SGPT (ALT)
|
20.0%
10/50 • Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
|
Additional Information
Dr. Hugo Castro-Malaspina
Memorial Sloan-Kettering Cancer Center
Phone: 212-639-8197
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place