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Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00027560
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions Biological: alemtuzumab
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: melphalan
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Enrollment 51
Recruitment Details 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
Pre-assignment Details Enrolled participants receive preparative cytoreduction prior to transplant.
Arm/Group Title TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Hide Arm/Group Description This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
Period Title: Overall Study
Started 51
Completed 50
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Hide Arm/Group Description 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 Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
3
   5.9%
Between 18 and 65 years
46
  90.2%
>=65 years
2
   3.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
42.9  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
15
  29.4%
Male
36
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
1.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 12 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Population is defined as all participants who received transplant as per protocol.
Arm/Group Title TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Hide Arm/Group Description:
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 Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
37
2.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 24 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Population is defined as all participants who received transplant as per protocol.
Arm/Group Title TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Hide Arm/Group Description:
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 Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
30
3.Primary Outcome
Title Acute Graft-versus-Host Disease Matched Related Patients
Hide Description Grade III-IV Acute Graft-versus-Host Disease
Time Frame up to 4 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The number of matched related patients was analyzed as per protocol.
Arm/Group Title Matched Related Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
1
4.Secondary Outcome
Title Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients
Hide Description Grade III-IV Acute Graft-versus-Host Disease
Time Frame up to 4 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The number of unrelated and mismatched patients was analyzed as per protocol.
Arm/Group Title Unrelated and Mismatched Related Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
3
5.Secondary Outcome
Title Extensive Chronic Graft-versus-Host Disease Matched Related Patients
Hide Description [Not Specified]
Time Frame up to 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The number of matched related patients was analyzed as per protocol.
Arm/Group Title Matched Related Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients
Hide Description [Not Specified]
Time Frame up to 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The number of unrelated and mismatched patients was analyzed as per protocol.
Arm/Group Title Unrelated and Mismatched Related Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
2
Time Frame 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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Hide Arm/Group Description This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
All-Cause Mortality
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Affected / at Risk (%) # Events
Total   3/50 (6.00%)    
General disorders   
Constitut symp, other  1  1/50 (2.00%)  1
Infections and infestations   
Infection with grade 3/4 neut  1  1/50 (2.00%)  1
Infection w.out neutropenia  1  1/50 (2.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
Affected / at Risk (%) # Events
Total   43/50 (86.00%)    
Blood and lymphatic system disorders   
Hyperglycemia  1  8/50 (16.00%) 
Transfusion (PLT/BMT)  1  9/50 (18.00%) 
Gastrointestinal disorders   
Stomatitis/BMT  1  9/50 (18.00%) 
Hepatobiliary disorders   
SGOT (AST)  1  8/50 (16.00%) 
Bilirubin increased  1  12/50 (24.00%) 
Alkaline phosphatase  1  8/50 (16.00%) 
SGPT (ALT)  1  10/50 (20.00%) 
Metabolism and nutrition disorders   
Creatinine increased  1  32/50 (64.00%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  13/50 (26.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hugo Castro-Malaspina
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 212-639-8197
EMail: castro-h@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00027560     History of Changes
Other Study ID Numbers: 01-092
MSKCC-01092
NCI-G01-2028
First Submitted: December 7, 2001
First Posted: January 27, 2003
Results First Submitted: November 27, 2012
Results First Posted: January 7, 2013
Last Update Posted: January 7, 2013