Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath

This study has been completed.
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
David Rizzieri, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00578942
First received: December 19, 2007
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: April 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma
Myeloma
Leukemia
Myelodysplasia
Solid Tumors
Interventions: Drug: Campath Purged Non-myeloablative ASCT
Procedure: Donor Apheresis

  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
This study was opened and first consent obtained on 9/11/2002 and was closed to accrual on 2/18/2008 as enrollment goal was met. Recruitment took place at Duke hospital in the Bone Marrow Transplant clinic during time of clinical appointments in a private location. Follow up for survival was discontinued in April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to selecting a donor: donor and subjects had history and physical exam, labs and chest x-ray performed per program and FACT requirements. Female donors should have a negative pregnancy test. Subjects also had bone marrow aspirate/biopsy. Subjects were premedicated with Benadryl and acetaminophen.

Reporting Groups
  Description
Campath Purged Non-myeloablative ASCT

Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors

Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.

Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.


Participant Flow:   Overall Study
    Campath Purged Non-myeloablative ASCT  
STARTED     48  
COMPLETED     47  
NOT COMPLETED     1  
Lost to Follow-up                 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.

Cohort of subjects who actually received at least 1 donor lymphocyte infusion (DLI).

DLI dosages thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.


Reporting Groups
  Description
Campath Purged Non-myeloablative ASCT

Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors

Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.

Patient Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.


Baseline Measures
    Campath Purged Non-myeloablative ASCT  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     41  
>=65 years     6  
Gender  
[units: participants]
 
Female     17  
Male     31  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     42  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     47  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
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1.  Primary:   Toxicity   [ Time Frame: 1 year ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: 8 years ]

3.  Secondary:   Response   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: David Rizzieri, MD
Organization: Duke University Medical Center
phone: 919-668-1040
e-mail: david.rizzieri@duke.edu


No publications provided


Responsible Party: David Rizzieri, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00578942     History of Changes
Other Study ID Numbers: Pro00008380
Study First Received: December 19, 2007
Results First Received: April 25, 2014
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board