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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00027560
First received: December 7, 2001
Last updated: December 3, 2012
Last verified: December 2012
Results First Received: November 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants receive preparative cytoreduction prior to transplant.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES  
STARTED     51  
COMPLETED     50  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES  
Number of Participants  
[units: participants]
  51  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     46  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  42.9  ± 15  
Gender  
[units: participants]
 
Female     15  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     51  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 12 months post transplant ]

2.  Primary:   Overall Survival   [ Time Frame: 24 months post transplant ]

3.  Primary:   Acute Graft-versus-Host Disease Matched Related Patients   [ Time Frame: up to 4 months post transplant ]

4.  Secondary:   Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients   [ Time Frame: up to 4 months post transplant ]

5.  Secondary:   Extensive Chronic Graft-versus-Host Disease Matched Related Patients   [ Time Frame: up to 2 years post transplant ]

6.  Secondary:   Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients   [ Time Frame: up to 2 years post transplant ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Hugo Castro-Malaspina
Organization: Memorial Sloan-Kettering Cancer Center
phone: 212-639-8197
e-mail: castro-h@mskcc.org


No publications provided


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
Study First Received: December 7, 2001
Results First Received: November 27, 2012
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board