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Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission

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ClinicalTrials.gov Identifier: NCT00382109
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : February 9, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Childhood Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
Graft Versus Host Disease
L1 Childhood Acute Lymphoblastic Leukemia
L2 Childhood Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Interventions Drug: thiotepa
Drug: cyclophosphamide
Drug: tacrolimus
Drug: methotrexate
Drug: sirolimus
Radiation: total body irradiation
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen Tacro-MTX GVHD Prophylaxis
Hide Arm/Group Description Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207. Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
Period Title: Overall Study
Started 76 70
Completed 64 66
Not Completed 12 4
Reason Not Completed
Adverse Event             3             0
Physician Decision             6             1
Withdrawal by Subject             1             0
ineligible             2             0
Other             0             2
consent withdrawal             0             1
Arm/Group Title Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen Tacro-MTX GVHD Prophylaxis Total
Hide Arm/Group Description Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207. Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors). Total of all reporting groups
Overall Number of Baseline Participants 76 70 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Year
Number Analyzed 76 participants 70 participants 146 participants
9
(1 to 20)
10
(1 to 21)
9
(1 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 70 participants 146 participants
Female
30
  39.5%
29
  41.4%
59
  40.4%
Male
46
  60.5%
41
  58.6%
87
  59.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 70 participants 146 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.6%
1
   1.4%
3
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   6.6%
6
   8.6%
11
   7.5%
White
59
  77.6%
51
  72.9%
110
  75.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
  13.2%
12
  17.1%
22
  15.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 70 participants 146 participants
Hispanic or Latino
23
  30.3%
16
  22.9%
39
  26.7%
Not Hispanic or Latino
51
  67.1%
53
  75.7%
104
  71.2%
Unknown or Not Reported
2
   2.6%
1
   1.4%
3
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 70 participants 146 participants
United States 71 62 133
Canada 3 2 5
Australia 2 6 8
1.Primary Outcome
Title Estimated Percentage of Participants With Event Free Survival
Hide Description An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.
Time Frame at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Two ineligible patients on experimental arm excluded from analysis.
Arm/Group Title Experimental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 74 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45
(34 to 60)
54
(41 to 69)
2.Secondary Outcome
Title Rate of Relapses
Hide Description An event is defined as relapse.
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
Arm/Group Title Experimental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 74 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41
(29 to 57)
33
(23 to 49)
3.Secondary Outcome
Title Estimated Transplant Related Mortality Percentage
Hide Description Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
2 ineligible patients on experimental arm excluded from analysis.
Arm/Group Title Experimental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 74 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13
(7 to 24)
6
(2 to 15)
4.Secondary Outcome
Title Estimated Rate of Acute Graft VS Host Disease (GVHD)
Hide Description Any grade acute graft vs host disease (defined in APPENDIX II study protocol).
Time Frame At 200 days
Hide Outcome Measure Data
Hide Analysis Population Description
2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.
Arm/Group Title Experiemental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 74 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(22 to 45)
49
(38 to 63)
5.Secondary Outcome
Title Estimated Rate of Overall Chronic Graft VS Host Disease
Hide Description Chronic graft vs host disease is defined in APPENDIX III of study protocol.
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.
Arm/Group Title Experimental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 74 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22
(14 to 36)
27
(18 to 40)
6.Secondary Outcome
Title Relative Contribution of Resistance by Acute Lymphoblastic Leukemia (ALL) Blasts to Cytolytic Therapy (e.g., Chemotherapy/Irradiation) as a Cause of Relapse Post-transplantation
Hide Description An event is defined as relapse or transplant-related mortality.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.
Arm/Group Title Experiemental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse)
Hide Description An event is defined as relapse; estimated probability of relapse.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Number at risk among no aGVHD and number at risk among aGVHD at 1 year. The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol, therefore results are not reported for each Arm of study.
Arm/Group Title All Patients
Hide Arm/Group Description:
Relative contribution of ALL blasts to the donor immune response as a cause of relapse post transplantation (correlating development of aGVHD with relapse).
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants
Experienced aGVHD, later relapsed Number Analyzed 35 participants
5
No aGVHD occurence, relapsed Number Analyzed 32 participants
24
8.Secondary Outcome
Title Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Pre-Transplantation (MRD)
Hide Description An event is defined as relapse; relapse risk is reported. Not able to be performed given the low numbers of blast samples available.
Time Frame At 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol. However, we are not able to perform this analysis given the low numbers of blast samples available.
Arm/Group Title All Patients
Hide Arm/Group Description:
Relative contribution of ALL blasts to the donor immune response as a cause of relapse pre transplantation (MRD)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Chimerism
Hide Description Evaluate the relative contribution of resistance by ALL blasts to the donor immune response as a cause of relapse post transplantation.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
We are not able to perform this analysis given the low numbers of blast samples available.
Arm/Group Title Experiemental Control
Hide Arm/Group Description:
Tacro-MTX/Sirolimus GVHD Prophylaxis
Tacro-MTX GVHD Prophylaxis
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). This study did not collect information about grade 1 and 2 AEs. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. 4 experimental patients were excluded (2 ineligible, 2 no data).
 
Arm/Group Title Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen Tacro-MTX GVHD Prophylaxis
Hide Arm/Group Description Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207. Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
All-Cause Mortality
Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen Tacro-MTX GVHD Prophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen Tacro-MTX GVHD Prophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   9/72 (12.50%)   5/70 (7.14%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1/72 (1.39%)  0/70 (0.00%) 
Cardiac disorders     
Cardiac disorders - Other, specify  0/72 (0.00%)  1/70 (1.43%) 
Pericardial effusion  1/72 (1.39%)  0/70 (0.00%) 
Gastrointestinal disorders     
Ascites  1/72 (1.39%)  1/70 (1.43%) 
General disorders     
Death NOS  0/72 (0.00%)  1/70 (1.43%) 
Multi-organ failure  2/72 (2.78%)  1/70 (1.43%) 
Hepatobiliary disorders     
Hepatic failure  0/72 (0.00%)  2/70 (2.86%) 
Hepatobiliary disorders - Other, specify  1/72 (1.39%)  0/70 (0.00%) 
Investigations     
Blood bilirubin increased  1/72 (1.39%)  1/70 (1.43%) 
Nervous system disorders     
Encephalopathy  0/72 (0.00%)  1/70 (1.43%) 
Seizure  0/72 (0.00%)  1/70 (1.43%) 
Renal and urinary disorders     
Acute kidney injury  1/72 (1.39%)  2/70 (2.86%) 
Renal and urinary disorders - Other, specify  1/72 (1.39%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1/72 (1.39%)  1/70 (1.43%) 
Bronchopulmonary hemorrhage  1/72 (1.39%)  0/70 (0.00%) 
Pneumonitis  1/72 (1.39%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  0/72 (0.00%)  1/70 (1.43%) 
Vascular disorders     
Hypotension  0/72 (0.00%)  1/70 (1.43%) 
Thromboembolic event  1/72 (1.39%)  0/70 (0.00%) 
Vascular disorders - Other, specify  1/72 (1.39%)  0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen Tacro-MTX GVHD Prophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   38/72 (52.78%)   30/70 (42.86%) 
Blood and lymphatic system disorders     
Anemia  5/72 (6.94%)  3/70 (4.29%) 
Blood and lymphatic system disorders - Other, specify  0/72 (0.00%)  1/70 (1.43%) 
Cardiac disorders     
Pericardial effusion  2/72 (2.78%)  0/70 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1/72 (1.39%)  0/70 (0.00%) 
Anal pain  1/72 (1.39%)  0/70 (0.00%) 
Ascites  2/72 (2.78%)  0/70 (0.00%) 
Diarrhea  1/72 (1.39%)  0/70 (0.00%) 
Gastrointestinal disorders - Other, specify  0/72 (0.00%)  1/70 (1.43%) 
Mucositis oral  1/72 (1.39%)  0/70 (0.00%) 
Vomiting  1/72 (1.39%)  0/70 (0.00%) 
General disorders     
Death NOS  0/72 (0.00%)  1/70 (1.43%) 
Localized edema  1/72 (1.39%)  0/70 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  0/72 (0.00%)  1/70 (1.43%) 
Immune system disorders     
Anaphylaxis  1/72 (1.39%)  0/70 (0.00%) 
Infections and infestations     
Bladder infection  0/72 (0.00%)  1/70 (1.43%) 
Infections and infestations - Other, specify  6/72 (8.33%)  1/70 (1.43%) 
Sepsis  1/72 (1.39%)  0/70 (0.00%) 
Investigations     
Alanine aminotransferase increased  2/72 (2.78%)  0/70 (0.00%) 
Aspartate aminotransferase increased  2/72 (2.78%)  2/70 (2.86%) 
Blood bilirubin increased  1/72 (1.39%)  0/70 (0.00%) 
Lymphocyte count decreased  12/72 (16.67%)  8/70 (11.43%) 
Neutrophil count decreased  22/72 (30.56%)  21/70 (30.00%) 
Platelet count decreased  22/72 (30.56%)  20/70 (28.57%) 
White blood cell decreased  23/72 (31.94%)  21/70 (30.00%) 
Metabolism and nutrition disorders     
Hypercalcemia  3/72 (4.17%)  1/70 (1.43%) 
Hyperglycemia  1/72 (1.39%)  2/70 (2.86%) 
Hyperkalemia  2/72 (2.78%)  2/70 (2.86%) 
Hypocalcemia  1/72 (1.39%)  0/70 (0.00%) 
Hypokalemia  8/72 (11.11%)  1/70 (1.43%) 
Hyponatremia  0/72 (0.00%)  1/70 (1.43%) 
Nervous system disorders     
Ataxia  1/72 (1.39%)  0/70 (0.00%) 
Encephalopathy  1/72 (1.39%)  0/70 (0.00%) 
Peripheral sensory neuropathy  0/72 (0.00%)  1/70 (1.43%) 
Seizure  1/72 (1.39%)  0/70 (0.00%) 
Tremor  1/72 (1.39%)  0/70 (0.00%) 
Psychiatric disorders     
Confusion  1/72 (1.39%)  0/70 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  2/72 (2.78%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1/72 (1.39%)  0/70 (0.00%) 
Atelectasis  1/72 (1.39%)  0/70 (0.00%) 
Dyspnea  1/72 (1.39%)  0/70 (0.00%) 
Hypoxia  3/72 (4.17%)  1/70 (1.43%) 
Laryngeal edema  1/72 (1.39%)  0/70 (0.00%) 
Pleural effusion  3/72 (4.17%)  0/70 (0.00%) 
Pneumonitis  2/72 (2.78%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1/72 (1.39%)  0/70 (0.00%) 
Skin and subcutaneous tissue disorders     
Stevens-Johnson syndrome  1/72 (1.39%)  0/70 (0.00%) 
Vascular disorders     
Capillary leak syndrome  1/72 (1.39%)  0/70 (0.00%) 
Hypertension  1/72 (1.39%)  0/70 (0.00%) 
Outcome Measures 6, 7, 8 and 9 are exploring in nature and did not investigate the actual relapse rates of the 2 treatment regiments.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00382109     History of Changes
Other Study ID Numbers: ASCT0431
NCI-2009-01068 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000500131 ( Other Identifier: Clinical Trials.gov )
COG-PBMTC-ONCO51 ( Other Identifier: Children's Oncology Group )
COG-ASCT0431 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: October 6, 2015
Results First Posted: February 9, 2017
Last Update Posted: August 7, 2019