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Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil

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ClinicalTrials.gov Identifier: NCT00608517
Recruitment Status : Terminated (slow accrual)
First Posted : February 6, 2008
Results First Posted : November 10, 2010
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methylprednisolone
Radiation: total-body irradiation
Enrollment 6

Recruitment Details Recruitment period = 9/23/2005 through 8/15/2008
Pre-assignment Details A total of 7 people signed consent to take part in this study. Of those, 1 was determined to be ineligible.
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1. Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1. Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Period Title: Overall Study
Started 2 3 1
Completed 1 3 1
Not Completed 1 0 0
Reason Not Completed
Death             1             0             0
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning Total
Hide Arm/Group Description Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1. Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1. Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1. Total of all reporting groups
Overall Number of Baseline Participants 2 3 1 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 1 participants 6 participants
<=18 years
2
 100.0%
0
   0.0%
0
   0.0%
2
  33.3%
Between 18 and 65 years
0
   0.0%
3
 100.0%
1
 100.0%
4
  66.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 1 participants 6 participants
8  (1) 31  (1) 42  (1) 31  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 1 participants 6 participants
Female
1
  50.0%
1
  33.3%
1
 100.0%
3
  50.0%
Male
1
  50.0%
2
  66.7%
0
   0.0%
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 1 participants 6 participants
2 3 1 6
1.Primary Outcome
Title Number of Participants With 100-day Non-relapse Mortality
Hide Description Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).
Time Frame 100 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 2 3 1
Measure Type: Number
Unit of Measure: participants
1 0 0
2.Secondary Outcome
Title Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells
Hide Description Recovery of the neutrophil portion of white blood cells and showing complete donor cells.
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment and who did not die before day 42.
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 1 2 0
Measure Type: Number
Unit of Measure: participants
1 1
3.Secondary Outcome
Title Number of Participants With Acute Graft-versus-host Disease (GVHD)
Hide Description Participants who exhibit acute GVHD.
Time Frame 100 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 2 3 1
Measure Type: Number
Unit of Measure: participants
0 1 0
4.Secondary Outcome
Title Number of Participants Who Relapsed at 1 Year
Hide Description [Not Specified]
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 2 3 1
Measure Type: Number
Unit of Measure: participants
0 0 0
5.Secondary Outcome
Title Number of Subjects With All-cause Mortality
Hide Description Death from any cause at 100 days
Time Frame at 100 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 2 3 1
Measure Type: Number
Unit of Measure: participants
1 0 0
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival at 1 year
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 2 3 1
Measure Type: Number
Unit of Measure: participants
1 3 1
7.Secondary Outcome
Title Number of Participants With Chronic Graft Versus Host Disease (GVHD)
Hide Description As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement
Time Frame 100 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description:
Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Overall Number of Participants Analyzed 2 3 1
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Hide Arm/Group Description Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1. Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1. Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
All-Cause Mortality
Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/3 (33.33%)      0/1 (0.00%)    
Infections and infestations       
MRSE  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Gram negative rods septicemia  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pediatric Myeloablative Conditioning Adult Myeloablative Conditioning Reduced-intensity Conditioning
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      2/3 (66.67%)      0/1 (0.00%)    
Blood and lymphatic system disorders       
Abnormal PTT  0/2 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0
Cardiac disorders       
Pericarditis  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Gastrointestinal disorders       
Mucositis (functional/symptomatic)  0/2 (0.00%)  0 2/3 (66.67%)  4 0/1 (0.00%)  0
Mucositis (clinical exam)  0/2 (0.00%)  0 2/3 (66.67%)  3 0/1 (0.00%)  0
Infections and infestations       
Catheter-related infection Grade 3-4 neutrophils (ANC < 1.0 x 10e9/L)  0/2 (0.00%)  0 2/3 (66.67%)  2 0/1 (0.00%)  0
Infection with normal ANC or Grade 1-2 neutrophils  0/2 (0.00%)  0 2/3 (66.67%)  4 0/1 (0.00%)  0
Infection with grade 3-4 neutrophils (ANC< 1.0 x 10e9/L)  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Bladder infection  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Catheter-related infection grade 1-2 neutrophils  0/2 (0.00%)  0 1/3 (33.33%)  3 0/1 (0.00%)  0
Infection with nomral ANC or grade 1-2 joint  0/2 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0
Urinary tract infection  0/2 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0
Investigations       
Creatinine increased  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  0/2 (0.00%)  0 2/3 (66.67%)  2 0/1 (0.00%)  0
Hyperglycemia  0/2 (0.00%)  0 2/3 (66.67%)  9 0/1 (0.00%)  0
Hyponatremia  0/2 (0.00%)  0 2/3 (66.67%)  3 0/1 (0.00%)  0
Hypophosphatemia  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Hyperkalemia  0/2 (0.00%)  0 1/3 (33.33%)  5 0/1 (0.00%)  0
Hyperuricemia  0/2 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteonecrosis  0/2 (0.00%)  0 1/3 (33.33%)  3 0/1 (0.00%)  0
Limb pain  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Joint pain  0/2 (0.00%)  0 1/3 (33.33%)  3 0/1 (0.00%)  0
Renal and urinary disorders       
Cystitis  0/2 (0.00%)  0 2/3 (66.67%)  4 0/1 (0.00%)  0
Bladder spasms  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Renal failure  0/2 (0.00%)  0 1/3 (33.33%)  3 0/1 (0.00%)  0
Urinary bleeding  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Reproductive system and breast disorders       
Testical pain  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Errectile dysfunction  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Libido  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia  0/2 (0.00%)  0 1/3 (33.33%)  5 0/1 (0.00%)  0
Hypoxia  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Pneumonitis  0/2 (0.00%)  0 1/3 (33.33%)  4 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders       
Cellulitis  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Vascular disorders       
Hypertension  0/2 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0
Thrombosis  0/2 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Brian Engelhardt, M.D.
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-936-1803
Responsible Party: Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00608517     History of Changes
Obsolete Identifiers: NCT00244036
Other Study ID Numbers: VICC BMT 0552
VU-VICC-BMT-0552
First Submitted: January 31, 2008
First Posted: February 6, 2008
Results First Submitted: October 11, 2010
Results First Posted: November 10, 2010
Last Update Posted: May 20, 2014