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Trial record 20 of 376 for:    cord blood stem cells

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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: NCT01093586
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : January 4, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Erythroleukemia (M6a)
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Adult Pure Erythroid Leukemia (M6b)
B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Blastic Phase Chronic Myelogenous Leukemia
Burkitt Lymphoma
Childhood Acute Erythroleukemia (M6)
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloid Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
de Novo Myelodysplastic Syndromes
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Juvenile Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Previously Treated Myelodysplastic Syndromes
Prolymphocytic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Anaplastic Large Cell Lymphoma
Recurrent Childhood Grade III Lymphomatoid Granulomatosis
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Small Noncleaved Cell Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Secondary Myelofibrosis
Splenic Marginal Zone Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
T-cell Large Granular Lymphocyte Leukemia
Waldenstrom Macroglobulinemia
Interventions Procedure: double-unit umbilical cord blood transplantation
Other: cytogenetic analysis
Procedure: bone marrow aspiration
Other: fluorescence in situ hybridization
Drug: busulfan
Drug: cyclophosphamide
Drug: anti-thymocyte globulin
Drug: methylprednisolone
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: flow cytometry
Procedure: allogeneic hematopoietic stem cell transplantation
Enrollment 14
Recruitment Details Participants recruited from medical hospital from 9/2007 thru 2/2013.
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Reason Not Completed
Failed to engraft             3
Arm/Group Title Arm I
Hide Arm/Group Description PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
10-19 yrs
2
  14.3%
20-29 yrs
2
  14.3%
30-39 yrs
3
  21.4%
40-49 yrs
5
  35.7%
50-59 yrs
2
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
8
  57.1%
Male
6
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
13
  92.9%
Unknown or Not Reported
1
   7.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  21.4%
White
11
  78.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Overall Survival
Hide Description Number of participants alive at 180 days post engraftment.
Time Frame On day +180
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that went on study, whether completing engraftment or not.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
8
  57.1%
2.Secondary Outcome
Title Hematologic Engraftment
Hide Description Number of participants that were able to complete engraftment by day 42.
Time Frame On day +42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that went on study.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
10
  71.4%
3.Secondary Outcome
Title Overall Survival
Hide Description Number of participants that were alive.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
6
  54.5%
4.Secondary Outcome
Title Overall Survival
Hide Description Number of participants that were alive.
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  36.4%
5.Secondary Outcome
Title Disease Free
Hide Description Number of participants that were disease free
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  36.4%
6.Secondary Outcome
Title Disease Free
Hide Description Number of participants that were disease free
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  36.4%
7.Secondary Outcome
Title Recurrence or Relapse
Hide Description Number of subjects that had disease recurrence
Time Frame one year in patients post UCBT
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
8.Secondary Outcome
Title Recurrence or Relapse
Hide Description Number of subjects that had disease recurrence
Time Frame two years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had completed engraftment
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
9.Secondary Outcome
Title Transplant Related Mortality
Hide Description Number of subjects that died because of transplant
Time Frame On day 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that went on study
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
2
  14.3%
10.Secondary Outcome
Title Transplant Related Mortality
Hide Description Number of subjects that died because of transplant
Time Frame On day 180 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that went on study
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
6
  42.9%
11.Secondary Outcome
Title Occurrence of Serious Infections
Hide Description Number of participants that had infections
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that went on study
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
13
  92.9%
12.Secondary Outcome
Title Immune Reconstitution
Hide Description Immunodificency panel to see recovery of immune system. Number of participants that recovered.
Time Frame Periodically for 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected, panel not done because of funding.
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
Hide Description Number of participants that experienced toxicity related to the transplant
Time Frame by day +42
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received transplant
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
8
  72.7%
14.Secondary Outcome
Title Incidence of Acute Graft-versus-host Disease (GVHD)
Hide Description Number of participants that had acute GVHD
Time Frame At 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who went on study
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
11
  78.6%
15.Secondary Outcome
Title Incidence of Chronic GVHD
Hide Description Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that went on study
Arm/Group Title Arm I
Hide Arm/Group Description:
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
1
   7.1%
Time Frame Adverse Events were collected from participant start on study to going off study up to a period of 2 years.
Adverse Event Reporting Description Non serious events were not collected. The protocol was assessing efficacy of cord blood in transplants, therefore the research was only gathering SAEs of grade 3 or 4.
 
Arm/Group Title Arm I
Hide Arm/Group Description PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   11/14 (78.57%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   9/14 (64.29%)    
Blood and lymphatic system disorders   
Bone marrow cellularity - Primary graft failure * 3  1/14 (7.14%)  1
Cardiac disorders   
Supraventricular and nodal arrhythmia - Sinus tachycardia * 2  1/14 (7.14%)  1
Hypotension * 3  1/14 (7.14%)  1
Gastrointestinal disorders   
Diarrhea * 1  3/14 (21.43%)  4
Colitis, infectious (e.g., Clostridium difficile) * 3  1/14 (7.14%)  1
General disorders   
Death not associated with CTCAE term - Multi-organ failure * 3  3/14 (21.43%)  3
Death not associated with CTCAE term - Death NOS * 3  2/14 (14.29%)  2
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 3  1/14 (7.14%)  1
Hepatobiliary disorders   
Bilirubin (hyperbilirubinemia) * 3  1/14 (7.14%)  1
Nervous system disorders   
Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious) * 3  1/14 (7.14%)  1
Product Issues   
Infection with normal ANC or Grade 1 or 2 neutrophils * 3 [1]  2/14 (14.29%)  2
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory - Nose * 3  1/14 (7.14%)  1
Hypoxia * 3  4/14 (28.57%)  5
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) * 3  1/14 (7.14%)  1
1
Term from vocabulary, CTCAEv3
2
Term from vocabulary, CTCAE v3
3
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
Catheter related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%) # Events
Total   0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Brenda Cooper MD
Organization: Case Comprehensive Cancer Center
Phone: 216-844-3213
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01093586     History of Changes
Other Study ID Numbers: CASE3Z07
NCI-2009-01319 ( Other Identifier: NCI/CTRP )
CASE3Z07 ( Other Identifier: Case Comprehensive Cancer Center )
First Submitted: March 24, 2010
First Posted: March 26, 2010
Results First Submitted: December 13, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 23, 2019