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Cellular Therapy With Cord Blood Cells

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ClinicalTrials.gov Identifier: NCT00427557
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : May 17, 2012
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Leukemia
Lymphoma
Interventions Drug: Fludarabine
Drug: Melphalan
Procedure: Umbilical Cord Blood
Drug: Rituximab
Other: Peripheral Blood Stem Cell Infusion
Enrollment 31
Recruitment Details Recruitment Period: January 05, 2007 to November 05, 2010. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details One participant of the 31 was enrolled but did not receive treatment.
Arm/Group Title Cellular Therapy With Cord Blood Cells
Hide Arm/Group Description Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Cellular Therapy With Cord Blood Cells
Hide Arm/Group Description Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
44  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
11
  36.7%
Male
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Engraftment
Hide Description Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment.
Time Frame Baseline to 100 days post-engraftment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol.
Arm/Group Title Fludarabine + Melphalan + Umbilical Cord Blood Unit
Hide Arm/Group Description:
Fludarabine 30 mg/m^2 given daily for four days. Melphalan 140 mg/m^2 given for one day. Umbilical Cord Blood Unit given on one day.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
27
Time Frame 10 Years and 3 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cellular Therapy With Cord Blood Cells
Hide Arm/Group Description Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
All-Cause Mortality
Cellular Therapy With Cord Blood Cells
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cellular Therapy With Cord Blood Cells
Affected / at Risk (%) # Events
Total   4/30 (13.33%)    
General disorders   
Graft Failure  1  1/30 (3.33%)  1
Nervous system disorders   
Ischemic Stroke  1  1/30 (3.33%)  1
Renal and urinary disorders   
Acute Renal Failure  1  2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure  1  2/30 (6.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cellular Therapy With Cord Blood Cells
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Thrombotic Thrombocytopenia Purpura  1  2/30 (6.67%)  2
Hemolytic Anemia  1  1/30 (3.33%)  1
Cardiac disorders   
Congestive Heart Failure  1  3/30 (10.00%)  3
Myocarditis  1  1/30 (3.33%)  1
Cardiomyopathy  1  1/30 (3.33%)  1
Hypertension  1  6/30 (20.00%)  6
Low Blood Pressure  1  1/30 (3.33%)  1
Tachycardia  1  1/30 (3.33%)  1
Eye disorders   
Blurry Vision  1  2/30 (6.67%)  2
Gastrointestinal disorders   
Diarrhea  1  14/30 (46.67%)  14
Mucositis  1  21/30 (70.00%)  21
GastrointestinaI Bleed  1  2/30 (6.67%)  2
Nausea  1  30/30 (100.00%)  30
General disorders   
Graft vs Host Disease  1  22/30 (73.33%)  41
Delayed Engraftment  1  2/30 (6.67%)  2
Fever  1  21/30 (70.00%)  21
Fatigue  1  2/30 (6.67%)  2
Fluid Overload  1  4/30 (13.33%)  4
Encephalopathy  1  2/30 (6.67%)  2
Headache  1  3/30 (10.00%)  3
Hepatobiliary disorders   
Elevated Liver Function Tests  1  12/30 (40.00%)  12
Veno Occulusive Disease  1  1/30 (3.33%)  1
Infections and infestations   
Infection  1  22/30 (73.33%)  45
Nervous system disorders   
Neuropathy  1  1/30 (3.33%)  1
Renal and urinary disorders   
Elevated Creatinine  1  2/30 (6.67%)  2
Hemorrhagic Cystitis  1  8/30 (26.67%)  8
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1  1/30 (3.33%)  1
Diffuse Alveolar Hemorrhage  1  4/30 (13.33%)  4
Pneumonia  1  5/30 (16.67%)  5
Shortness of Breath  1  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Skin Rash  1  8/30 (26.67%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Partow Kebriaei
Organization: MD Anderson Cancer Center
Phone: 713-563-5174
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00427557     History of Changes
Other Study ID Numbers: 2006-0553
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: April 19, 2012
Results First Posted: May 17, 2012
Last Update Posted: May 28, 2012