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Allogeneic Stem Cell Transplantation, Severe Homzygous 0/+Thalassemia or Sever Variants of Beta 0/+ Thalassemia, THALLO (THALLO)

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ClinicalTrials.gov Identifier: NCT00578292
Recruitment Status : Terminated (Stem cell transplant was determined SOC for this disease (study is not relevant))
First Posted : December 21, 2007
Results First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Tami D. John, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thalassemia
Interventions Drug: Busulfan
Drug: Fludarabine
Drug: Campath 1H
Drug: Cyclophosphamide
Drug: MESNA
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Period Title: Overall Study
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Death             1
Graft failure             2
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
Participants received allogeneic hematopoietic stem cell transplantation (SCT) from unrelated donors.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
6
(2 to 13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
1
  10.0%
Not Hispanic or Latino
9
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  70.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
  30.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Engraftment Rate After Transplant
Hide Description Engraftment is defined as an absolute neutrophil count (ANC) >500/microL x 3 days.
Time Frame up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) from unrelated donors.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
1
(0.69 to 1)
2.Primary Outcome
Title Number of Participants With Stable Mixed Hematopoietic Chimerism (HC)
Hide Description Stable hematopoietic chimerism is defined as having 50-99 percent of donor cells.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) from unrelated donors and had mixed chimerism (MC). Six participants were not evaluable at the time point of assessment for this outcome measure due to death or graft failure or full donor.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
3.Primary Outcome
Title Number of Participants With Transient Mixed Hematopoietic Chimerism (HC)
Hide Description Transient mixed hematopoietic chimerism is defined as any mixed chimerism return to 100 percent donor.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) from unrelated donors and had mixed chimerism (MC). Six participants were not evaluable at the time point of assessment for this outcome measure due to death or graft failure or full donor.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Number of Participants With Infectious Complications
Hide Description All AEs and SAEs (including infections) will be collected for evaluation of infectious complications.
Time Frame up to day 100
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) from unrelated donors.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
5.Primary Outcome
Title Hematopoietic Reconstitution
Hide Description Hematopoietic: defined as transfusion independence.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) and were evaluable for the outcome measure. Two participants were not evaluated at the time point of assessment for this outcome measure due to death or graft failure.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
6.Primary Outcome
Title Immune Reconstitution
Hide Description Immune reconstitution: defined as absolute lymphocyte count (ALC) >1000x10e3/microL
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) and were evaluable for the outcome measure. Two participants were not evaluated at the time point of assessment for this outcome measure due to death or graft failure.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
7.Primary Outcome
Title Number of Participants With ACUTE GVHD
Hide Description Acute GVHD is graded by the method of Przepiorka D. et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD
Time Frame Assessed weekly from Day 0 to day 100
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) and were evaluable for acute GVHD. A participant is evaluable for acute GVHD if he/she engrafted and either completed 100 days observation after transplant or experienced acute GVHD.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0
4
  40.0%
Grade I
4
  40.0%
Grade II-IV
2
  20.0%
8.Primary Outcome
Title Number of Participants With CHRONIC GVHD
Hide Description Chronic GVHD is graded by NIH guidelines for chronic GVHD, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3 where 0 means no chronic GVHD, and 3 is the highest stage of chronic GVHD.
Time Frame Assessed monthly from month 3 to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) and were evaluable for chronic GVHD. A participant is evaluable for chronic GVHD if he/she engrafted and survived or remained in the study for more than 100 days after transplant.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  12.5%
9.Primary Outcome
Title Event-free Survival
Hide Description Event-free survival is calculated from the date of transplant to the date of graft failure, disease recurrence or death from any cause.
Time Frame up to 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants who underwent allogeneic hematopoietic stem cell transplantation (SCT) from unrelated donors.
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description:

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of event-free survival
0.7
(0.33 to 0.89)
Time Frame Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
Adverse Event Reporting Description All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
 
Arm/Group Title Bone Marrow or Stem Cell Infusion
Hide Arm/Group Description

Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H

Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.

Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.

Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg

Days -9 through -6

Fludarabine: 30mg/m2 Day -5 through Day -2

Campath 1H: Per institutional guidelines Days -5 through -2

Cyclophosphamide: 50 mg/kg Days -5 through -2

MESNA: 10 mg/kg x 5 Days -5 through -2

All-Cause Mortality
Bone Marrow or Stem Cell Infusion
Affected / at Risk (%)
Total   1/10 (10.00%)    
Hide Serious Adverse Events
Bone Marrow or Stem Cell Infusion
Affected / at Risk (%) # Events
Total   4/10 (40.00%)    
Gastrointestinal disorders   
Diarrhea  1  1/10 (10.00%)  1
Infections and infestations   
Catheter related Infection  1  1/10 (10.00%)  1
Investigations   
Aspartate aminotransferase increased  1  1/10 (10.00%)  1
Alanine aminotransferase increased  1  2/10 (20.00%)  2
Renal and urinary disorders   
Hematuria  1  1/10 (10.00%)  1
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bone Marrow or Stem Cell Infusion
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Cardiac disorders   
Cardiac disorders-Other: Cardiomegaly  1  1/10 (10.00%)  1
Sinus tachycardia  1  1/10 (10.00%)  1
Eye disorders   
Eye disorders -Other: PRES  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Abdominal Pain  1  2/10 (20.00%)  3
Ascites  1  1/10 (10.00%)  1
Diarrhea  1  2/10 (20.00%)  3
Gastric ulcer  1  1/10 (10.00%)  1
Gastritis  1  1/10 (10.00%)  1
Anal hemorrhage  1  2/10 (20.00%)  2
Nausea  1  1/10 (10.00%)  1
Stomatitis/Pharyngitis (oral/pharyngeal mucositis)  1  2/10 (20.00%)  2
Vomiting  1  1/10 (10.00%)  2
General disorders   
Pain  1  1/10 (10.00%)  3
Pelvic Pain  1  1/10 (10.00%)  1
Hepatobiliary disorders   
Hepatobiliary disorders-Other: GVHD  1  1/10 (10.00%)  1
Hepatobiliary disorders-Other: hepatic VOD  1  1/10 (10.00%)  1
Infections and infestations   
Catheter Related Infection  1  3/10 (30.00%)  3
Infections and infestations - Other: Parainfluenza virus  1  1/10 (10.00%)  1
Infections and infestations - Other: CMV reactivation  1  1/10 (10.00%)  1
Infections and infestations - Other: Gram negative rods  1  2/10 (20.00%)  3
Infections and infestations - Other: BK virus  1  3/10 (30.00%)  4
Infections and infestations - Other: HSV  1  1/10 (10.00%)  1
Wound-Infectious  1  1/10 (10.00%)  1
Investigations   
Blood bilirubin increased  1  4/10 (40.00%)  6
GGT increased  1  5/10 (50.00%)  20
Lipase  1  1/10 (10.00%)  1
Partial thromboplastin time (PTT)  1  1/10 (10.00%)  1
Prothrombin time (PT)  1  2/10 (20.00%)  3
Aspartate aminotransferase increased  1  8/10 (80.00%)  31
Alanine aminotransferase increased  1  6/10 (60.00%)  31
Metabolism and nutrition disorders   
Acidosis  1  1/10 (10.00%)  2
Alkalosis  1  1/10 (10.00%)  1
Anorexia  1  1/10 (10.00%)  1
Hyperkalemia  1  2/10 (20.00%)  4
Hypermagnesemia  1  2/10 (20.00%)  2
Hypertriglyceridemia  1  5/10 (50.00%)  11
Hypoalbuminemia  1  6/10 (60.00%)  30
Hypocalcemia  1  1/10 (10.00%)  1
Hypokalemia  1  3/10 (30.00%)  10
Hypomagnesemia  1  1/10 (10.00%)  1
Hyponatremia  1  3/10 (30.00%)  3
Hypophosphatemia  1  3/10 (30.00%)  3
Nervous system disorders   
Headache  1  1/10 (10.00%)  1
Nervous system disorders-Other: Altered mental status  1  1/10 (10.00%)  1
Psychiatric disorders   
Hallucinations  1  2/10 (20.00%)  2
Renal and urinary disorders   
Dysuria (painful urination)  1  3/10 (30.00%)  3
Hematuria  1  2/10 (20.00%)  2
Hemoglobinuria  1  2/10 (20.00%)  2
Cystitis noninfective  1  1/10 (10.00%)  1
Proteinuria  1  4/10 (40.00%)  10
Renal Failure  1  1/10 (10.00%)  1
Renal and urinary disorders-Other: Nitrite in urine  1  1/10 (10.00%)  1
Urine discoloration  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/10 (10.00%)  1
Hypoxia  1  1/10 (10.00%)  2
Pleural Effusion  1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/10 (10.00%)  1
Rash  1  2/10 (20.00%)  3
Vascular disorders   
Hypertension  1  3/10 (30.00%)  3
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
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: Dr. Tami D. John
Organization: Baylor College of Medicine/Texas Children's Hospital
Phone: 832-824-4723
EMail: tdjohn@texaschildrens.org
Layout table for additonal information
Responsible Party: Tami D. John, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00578292    
Other Study ID Numbers: THALLO (H-14539)
H-14539 ( Other Identifier: Baylor College of Medicine IRB )
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: April 3, 2020
Results First Posted: May 1, 2020
Last Update Posted: May 1, 2020