Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Allogeneic Transplantation From Related Haploidentical Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185692
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Lowsky, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Blood Cancer
Leukemia
Graft Versus Host Disease
Malignancy
CLL
NHL
Hodgkin's Disease
MDS
Interventions Procedure: non-myeloablative hematopoietic cell transplantation
Drug: Anti-Thymocyte Globulin
Drug: Cyclosporine
Drug: Mycophenolate Mofetil
Drug: G-CSF
Drug: Solumedrol
Drug: Acetaminophen
Drug: Diphenydramine
Drug: Hydrocortisone
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transplating of CD34+ Selected Hematopietic Cells
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 16
Completed 0
Not Completed 16
Arm/Group Title Transplating of CD34+ Selected Hematopietic Cells
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
52
(14 to 61)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
4
  25.0%
Not Hispanic or Latino
12
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
  87.5%
More than one race
1
   6.3%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
Hide Description number achieving donor cell engraftment (>95%) by day 90 after transplant.
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplantation of CD34+ Cells
Hide Arm/Group Description:

Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.

Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.

non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.

Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.

Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.

Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).

Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
4
  25.0%
2.Secondary Outcome
Title Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
Hide Description GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplantation of CD34+ Cells
Hide Arm/Group Description:

Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.

Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.

non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.

Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.

Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.

Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).

Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
Time Frame Per the common rule adverse events were not collected for the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplating of CD34+ Selected Hematopietic Cells
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Transplating of CD34+ Selected Hematopietic Cells
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transplating of CD34+ Selected Hematopietic Cells
Affected / at Risk (%) # Events
Total   14/16 (87.50%)    
General disorders   
Death   14/16 (87.50%)  14
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 01%
Transplating of CD34+ Selected Hematopietic Cells
Affected / at Risk (%) # Events
Total   0/0    
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: Robert Lowsky
Organization: Stanford University
Phone: 650-723-0822
EMail: rlowsky@stanford.edu
Layout table for additonal information
Responsible Party: Robert Lowsky, Stanford University
ClinicalTrials.gov Identifier: NCT00185692     History of Changes
Other Study ID Numbers: IRB-13371
75117 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT 124 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: December 1, 2016
Results First Posted: January 26, 2017
Last Update Posted: January 26, 2017