Allo Non-Myeloablative SCT Utilizing Mis-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:
NCT00580034
First received: December 20, 2007
Last updated: May 2, 2014
Last verified: May 2014
Results First Received: February 5, 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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in February, 2003 and ended in February, 2008. Recruitment took place at Duke and Florida hospitals in the Bone Marrow Transplant clinics during time of clinical appointments in a private location.

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. Prior to treatment, disease progression and insurance denial led to removal from the study.

Reporting Groups
  Description
Campath Purged Non-myeloablative ASCT

Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors

Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.

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.

Donor Apheresis

Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:

  1. Adequate cardiac function by history and physical examination
  2. bilirubin and hepatic transaminases < 2.5 x upper limit of normal
  3. normal hematologic parameters Females should have a negative serum pregnancy test.

Participant Flow:   Overall Study
    Campath Purged Non-myeloablative ASCT     Donor Apheresis  
STARTED     88     88  
COMPLETED     78     88  
NOT COMPLETED     10     0  
Toxicity                 10                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 patients 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 ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors

Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.

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]
  88  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     80  
>=65 years     8  
Age  
[units: years]
Mean ± Standard Deviation
  49  ± 24  
Gender  
[units: participants]
 
Female     34  
Male     54  
Region of Enrollment  
[units: participants]
 
United States     88  



  Outcome Measures
  Show All Outcome Measures

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

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

3.  Secondary:   Response   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


Publications of Results:

Responsible Party: David Rizzieri, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00580034     History of Changes
Other Study ID Numbers: Pro00009528
Study First Received: December 20, 2007
Results First Received: February 5, 2014
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board