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Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

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: NCT00440726
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphoblastic Leukemia
Interventions Drug: Bortezomib
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Doxorubicin
Drug: Cytarabine
Drug: Methotrexate
Drug: Vincristine
Drug: Triple IT Therapy
Enrollment 31
Recruitment Details 31 unique individual participants were enrolled into the study collectively for both Phase 1 and 2. The breakdown is as follows: 10 in the Phase I study and 21 in the Phase II study. There was, however, one patient that started on Phase I, Cohort 2 that was later eligible and rolled into the Phase II study.
Pre-assignment Details  
Arm/Group Title Phase 1: Cohort 1 Bortezomib 1mg/m2/Day (Dose Level 1) Phase 1: Cohort 2 Bortezomib 1.3 mg/m2/Day (Dose Level 2) Phase 2: Bortezomib 1.3 mg/m2/Day (Efficacy)
Hide Arm/Group Description The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level. If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level. After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.
Period Title: Phase 1
Started 4 6 0
Completed 3 5 0
Not Completed 1 1 0
Reason Not Completed
Dose-Limiting Toxicity             0             1             0
Physician Decision             1             0             0
Period Title: Phase 2
Started 0 0 22
Completed 0 0 20
Not Completed 0 0 2
Reason Not Completed
Death             0             0             1
Adverse Event             0             0             1
Arm/Group Title Phase 1 Dose Level 1 Phase 1 Dose Level 2 Phase 2 Efficacy Total
Hide Arm/Group Description

Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11, dose-escalation

Dexamethasone: Intravenous or oral administration for 14 days.

PEG-asparaginase: Intramuscular injection

Doxorubicin: Intravenous infusion

Cytarabine: Intrathecal administration on day 1

Methotrexate: Intrathecal administration

Vincristine: Intravenous push on days 1, 8, 15, 22

The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.

If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level

After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.

Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11 at 1.3 mg/m2/day

Dexamethasone: Intravenous or oral administration for 14 days.

PEG-asparaginase: Intramuscular injection

Doxorubicin: Intravenous infusion

Cytarabine: Intrathecal administration on day 1

Methotrexate: Intrathecal administration

Vincristine: Intravenous push on days 1, 8, 15, 22

Total of all reporting groups
Overall Number of Baseline Participants 4 6 21 31
Hide Baseline Analysis Population Description
31 unique individual participants were enrolled into the study collectively for both Phase 1 and 2. The breakdown is as follows: 10 in the Phase I study and 21 in the Phase II study. There was, however, one patient that started on Phase I, Cohort 2 that was later eligible and rolled into the Phase II study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 21 participants 31 participants
<=18 years
4
 100.0%
6
 100.0%
19
  90.5%
29
  93.5%
Between 18 and 65 years
0
   0.0%
0
   0.0%
2
   9.5%
2
   6.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 21 participants 31 participants
Female
3
  75.0%
5
  83.3%
7
  33.3%
15
  48.4%
Male
1
  25.0%
1
  16.7%
14
  66.7%
16
  51.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 21 participants 31 participants
Hispanic or Latino
3
  75.0%
1
  16.7%
5
  23.8%
9
  29.0%
Not Hispanic or Latino
1
  25.0%
5
  83.3%
12
  57.1%
18
  58.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
4
  19.0%
4
  12.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 21 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
2
   9.5%
2
   6.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
6
 100.0%
19
  90.5%
29
  93.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lineage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 21 participants 21 participants
B-precursor ALL
19
  90.5%
19
  90.5%
T-cell ALL
2
   9.5%
2
   9.5%
[1]
Measure Analysis Population Description: Patients in the dose escalation group were not stratified by lineage
Prior Treatment Attempts  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 21 participants 31 participants
One
1
  25.0%
4
  66.7%
0
   0.0%
5
  16.1%
Two
3
  75.0%
1
  16.7%
16
  76.2%
20
  64.5%
Three
0
   0.0%
0
   0.0%
5
  23.8%
5
  16.1%
Four
0
   0.0%
1
  16.7%
0
   0.0%
1
   3.2%
Previous Bone Marrow Transplant   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 21 participants 21 participants
None
17
  81.0%
17
  81.0%
Yes
4
  19.0%
4
  19.0%
[1]
Measure Analysis Population Description: Patients in the dose escalation group not stratified by previous BM transplant.
Bone Marrow M3 at study entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 21 participants 21 participants
21
 100.0%
21
 100.0%
[1]
Measure Analysis Population Description: Patients in the dose escalation group not stratified by leukemic blast status
1.Primary Outcome
Title Occurrence of a Dose-Limiting Toxicity (Phase 1)
Hide Description Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4 Non-Hematologic Toxicity excluding the following: Infection (septic shock, typhlitis), Fever/Neutropenia, Fatigue, Electrolyte abnormalities, Hyper/Hypoglycemia, Nausea or Vomiting, AST/ALT/Bilirubin elevations that return to grade 1 by the time of the next course.
Time Frame Beginning with the first dose of investigational product until 30 days following the last dose of bortezomib
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ph 1, Dose Level 1 (1 mg/m2) Ph 1, Dose Level 2 (1.3 mg/m2)
Hide Arm/Group Description:
Phase 1 patients receiving 1 mg/m2 dose of bortezomib
Phase 1 patients receiving 1.3 mg/m2 dose of bortezomib
Overall Number of Participants Analyzed 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
DLT
0
   0.0%
1
  16.7%
No DLT
4
 100.0%
5
  83.3%
2.Primary Outcome
Title Achievement of Complete Remission (CR)
Hide Description
  • Complete Remission (CR): M1 (< 5% blasts) BM with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC>750/uL and platelet count >75 000/uL);
  • Complete Remission without Platelet Recovery (CRp): M1 BM with no circulating blasts or extramedullary disease and recovery of ANC (>750/uL) but insufficient recovery of platelets (<75 000/uL).
  • Partial Remission (PR): the disappearance of circulating blasts and achievement of M2 (5%-25% blasts) marrow status, without new sites of extramedullary disease, and with recovery of ANC (>750/uL).
  • Stable disease (SD): not satisfying the criterion for progressive disease (PD), or a recovery of ANC (>750/uL) but fails to qualify for CR, CRp, or PR.
  • Progressive Disease (PD): increase of at least 25% in the absolute number of circulating leukemia cells, development of new sites of extramedullary disease, or other lab or clinical evidence of PD, with or without recovery of ANC or platelets.
Time Frame Day 29 of Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
One Ph 1 patient received incorrect doses of Dexamethasone, so not evaluable for response. One Phase 2 patient achieved BM M1 but was treated with additional chemotherapy before peripheral recovery, so response to protocol treatment could not be evaluated.
Arm/Group Title Ph 1 Dose Escalation Ph 2 B-Precursor ALL Patients Ph 2 T-Cell ALL Patients
Hide Arm/Group Description:
Patients enrolled into the Phase 1 portion of the study
Patients enrolled into the Phase 2 portion of the study having B-Precursor ALL
Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
Overall Number of Participants Analyzed 9 19 2
Measure Type: Count of Participants
Unit of Measure: Participants
CR
6
  66.7%
14
  73.7%
0
   0.0%
CRp
0
   0.0%
2
  10.5%
0
   0.0%
SD/PD
1
  11.1%
0
   0.0%
2
 100.0%
BM-CR, CNS-SD
1
  11.1%
0
   0.0%
0
   0.0%
Death
1
  11.1%
3
  15.8%
0
   0.0%
3.Post-Hoc Outcome
Title Bone Marrow Response
Hide Description

M1: Less than 5% blasts in a bone marrow aspirate and at least 200 cells counted.

M2: 5-25% blasts in a bone marrow aspirate with at least 200 cells counted. M3: Greater than 25% blasts in a bone marrow aspirate with at least 200 cells counted.

Time Frame Day 29 of Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who enrolled and treated under Phase 2 will be evaluated at the end of Course 1 for treatment response as indicated by measure of bone marrow (M1, M2, or M3) or patient survival if death occurred.
Arm/Group Title Phase 2 B-Precursor ALL Patients Phase 2 T-cell ALL Patients
Hide Arm/Group Description:
Patients enrolled into the Phase 2 portion of the study having B-Precursor ALL
Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
Overall Number of Participants Analyzed 20 2
Measure Type: Count of Participants
Unit of Measure: Participants
M1
17
  85.0%
0
   0.0%
M2/M3
0
   0.0%
2
 100.0%
Death
3
  15.0%
0
   0.0%
Time Frame 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib
Adverse Event Reporting Description

The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions.

For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record.

Patients were evaluated regularly by the treating physician.

 
Arm/Group Title 1 mg/m2 Dose Group 1.3 mg/m2 Dose Group
Hide Arm/Group Description Patients receiving a 1 mg/m2 dose of bortezomib (known as Dose Level 1 in the Phase 1 portion). All patients in this group were from the Phase 1 portion of the study. Patients receiving a 1.3 mg/m2 dose of bortezomib (known as Dose Level 2 in the Phase 1 portion). This group includes patients from both the Phase 1 and Phase 2 portions of the study.
All-Cause Mortality
1 mg/m2 Dose Group 1.3 mg/m2 Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   5/27 (18.52%) 
Hide Serious Adverse Events
1 mg/m2 Dose Group 1.3 mg/m2 Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   17/27 (62.96%) 
Blood and lymphatic system disorders     
Bone marrow depression NOS  1  0/4 (0.00%)  1/27 (3.70%) 
Febrile neutropenia  1  1/4 (25.00%)  2/27 (7.41%) 
Gastrointestinal disorders     
Caecitis  1  1/4 (25.00%)  0/27 (0.00%) 
Diarrhea NOS  1  0/4 (0.00%)  1/27 (3.70%) 
Lower gastrointestinal hemorrhage  1  0/4 (0.00%)  1/27 (3.70%) 
Infections and infestations     
Infection w/ Gr 3/4 ANC, Blood  1  1/4 (25.00%)  8/27 (29.63%) 
Infection w/ Gr 3/4 ANC, Brain  1  0/4 (0.00%)  1/27 (3.70%) 
Infection w/ Gr 3/4 ANC, Skin  1  0/4 (0.00%)  1/27 (3.70%) 
Infection w/ norm ANC, Blood  1  0/4 (0.00%)  1/27 (3.70%) 
Infection w/ unk ANC, Mucosa  1  0/4 (0.00%)  1/27 (3.70%) 
Infection-Other  1  0/4 (0.00%)  1/27 (3.70%) 
Investigations     
Activated partial thromboplastin time prolonged  1  0/4 (0.00%)  1/27 (3.70%) 
Blood bilirubin increased  1  0/4 (0.00%)  1/27 (3.70%) 
Lipase increased  1  1/4 (25.00%)  1/27 (3.70%) 
Neutrophil count  1  0/4 (0.00%)  3/27 (11.11%) 
Platelet count decreased  1  0/4 (0.00%)  2/27 (7.41%) 
Metabolism and nutrition disorders     
Dehydration  1  0/4 (0.00%)  1/27 (3.70%) 
Hyperglycemia NOS  1  0/4 (0.00%)  2/27 (7.41%) 
Hypocalcaemia  1  0/4 (0.00%)  1/27 (3.70%) 
Hypokalemia  1  0/4 (0.00%)  1/27 (3.70%) 
Hyponatremia  1  1/4 (25.00%)  2/27 (7.41%) 
Hypophosphatemia  1  0/4 (0.00%)  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/4 (0.00%)  1/27 (3.70%) 
Myositis  1  0/4 (0.00%)  1/27 (3.70%) 
Nervous system disorders     
Depressed level of consciousness  1  0/4 (0.00%)  1/27 (3.70%) 
Encephalopathy  1  0/4 (0.00%)  1/27 (3.70%) 
Peripheral motor neuropathy  1  0/4 (0.00%)  2/27 (7.41%) 
Peripheral sensory neuropathy  1  0/4 (0.00%)  2/27 (7.41%) 
Syncope  1  0/4 (0.00%)  1/27 (3.70%) 
Psychiatric disorders     
Confusion  1  0/4 (0.00%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  0/4 (0.00%)  2/27 (7.41%) 
Pleural effusion  1  0/4 (0.00%)  1/27 (3.70%) 
Pneumonia NOS  1  0/4 (0.00%)  1/27 (3.70%) 
Pneumonitis NOS  1  0/4 (0.00%)  1/27 (3.70%) 
Vascular disorders     
Cerebral ischaemia  1  0/4 (0.00%)  2/27 (7.41%) 
Hypertension  1  0/4 (0.00%)  1/27 (3.70%) 
Hypotension NOS  1  0/4 (0.00%)  2/27 (7.41%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 mg/m2 Dose Group 1.3 mg/m2 Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   27/27 (100.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/4 (25.00%)  2/27 (7.41%) 
Hemoglobin  1  4/4 (100.00%)  20/27 (74.07%) 
Leukopenia NOS  1  4/4 (100.00%)  22/27 (81.48%) 
Lymphopenia  1  1/4 (25.00%)  5/27 (18.52%) 
Neutrophil count  1  4/4 (100.00%)  12/27 (44.44%) 
Platelet count decreased  1  3/4 (75.00%)  21/27 (77.78%) 
Cardiac disorders     
Sinus bradycardia  1  1/4 (25.00%)  1/27 (3.70%) 
Endocrine disorders     
Cushingoid  1  0/4 (0.00%)  2/27 (7.41%) 
Gastrointestinal disorders     
Abdominal pain NOS  1  1/4 (25.00%)  8/27 (29.63%) 
Constipation  1  2/4 (50.00%)  6/27 (22.22%) 
Diarrhea NOS  1  3/4 (75.00%)  8/27 (29.63%) 
Nausea  1  2/4 (50.00%)  8/27 (29.63%) 
Oral pain  1  1/4 (25.00%)  2/27 (7.41%) 
Pancreatitis NOS  1  1/4 (25.00%)  1/27 (3.70%) 
Proctalgia  1  1/4 (25.00%)  0/27 (0.00%) 
Stomatitis  1  2/4 (50.00%)  3/27 (11.11%) 
Vomiting NOS  1  2/4 (50.00%)  6/27 (22.22%) 
General disorders     
Edema: limb  1  0/4 (0.00%)  2/27 (7.41%) 
Fatigue  1  0/4 (0.00%)  6/27 (22.22%) 
Hypothermia  1  0/4 (0.00%)  2/27 (7.41%) 
Myalgia  1  0/4 (0.00%)  2/27 (7.41%) 
Pain NOS  1  0/4 (0.00%)  3/27 (11.11%) 
Pain, External ear  1  0/4 (0.00%)  2/27 (7.41%) 
Pain-Other  1  0/4 (0.00%)  6/27 (22.22%) 
Pyrexia  1  1/4 (25.00%)  5/27 (18.52%) 
Rigors  1  1/4 (25.00%)  3/27 (11.11%) 
Hepatobiliary disorders     
Hepatobiliary/Pancreas-Other  1  1/4 (25.00%)  0/27 (0.00%) 
Infections and infestations     
Clostridial infection NOS  1  1/4 (25.00%)  0/27 (0.00%) 
Implant site infection  1  1/4 (25.00%)  0/27 (0.00%) 
Infection w/ Gr 3/4 ANC, Blood  1  0/4 (0.00%)  2/27 (7.41%) 
Infection-Other  1  0/4 (0.00%)  2/27 (7.41%) 
Investigations     
Activated partial thromboplastin time prolonged  1  3/4 (75.00%)  3/27 (11.11%) 
Alanine aminotransferase increased  1  3/4 (75.00%)  19/27 (70.37%) 
Aspartate aminotransferase increased  1  2/4 (50.00%)  17/27 (62.96%) 
Blood alkaline phosphatase increased  1  1/4 (25.00%)  7/27 (25.93%) 
Blood amylase increased  1  1/4 (25.00%)  2/27 (7.41%) 
Blood bicarbonate decreased  1  1/4 (25.00%)  1/27 (3.70%) 
Blood bilirubin increased  1  1/4 (25.00%)  7/27 (25.93%) 
Blood creatinine increased  1  0/4 (0.00%)  4/27 (14.81%) 
Blood fibrinogen  1  2/4 (50.00%)  4/27 (14.81%) 
Electrocardiogram QT prolonged  1  1/4 (25.00%)  0/27 (0.00%) 
Lipase increased  1  0/4 (0.00%)  2/27 (7.41%) 
Metabolic/Lab-Other  1  0/4 (0.00%)  2/27 (7.41%) 
Prothrombin time prolonged  1  1/4 (25.00%)  6/27 (22.22%) 
Metabolism and nutrition disorders     
Anorexia  1  0/4 (0.00%)  3/27 (11.11%) 
Dehydration  1  0/4 (0.00%)  2/27 (7.41%) 
Hypercalcemia  1  1/4 (25.00%)  3/27 (11.11%) 
Hyperglycemia NOS  1  3/4 (75.00%)  18/27 (66.67%) 
Hyperkalemia  1  0/4 (0.00%)  9/27 (33.33%) 
Hypermagnesemia  1  2/4 (50.00%)  5/27 (18.52%) 
Hypernatraemia  1  0/4 (0.00%)  2/27 (7.41%) 
Hypertriglyceridemia  1  1/4 (25.00%)  2/27 (7.41%) 
Hypoalbuminemia  1  2/4 (50.00%)  23/27 (85.19%) 
Hypocalcemia  1  3/4 (75.00%)  20/27 (74.07%) 
Hypoglycemia NOS  1  2/4 (50.00%)  8/27 (29.63%) 
Hypokalaemia  1  3/4 (75.00%)  11/27 (40.74%) 
Hypomagnesemia  1  1/4 (25.00%)  4/27 (14.81%) 
Hyponatremia  1  3/4 (75.00%)  21/27 (77.78%) 
Hypophosphatemia  1  2/4 (50.00%)  14/27 (51.85%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/4 (0.00%)  3/27 (11.11%) 
Nervous system disorders     
Convulsions NOS  1  0/4 (0.00%)  2/27 (7.41%) 
Dizziness  1  0/4 (0.00%)  3/27 (11.11%) 
Headache  1  1/4 (25.00%)  2/27 (7.41%) 
Hypotension NOS  1  1/4 (25.00%)  7/27 (25.93%) 
Peripheral sensory neuropathy  1  0/4 (0.00%)  3/27 (11.11%) 
Tremor  1  0/4 (0.00%)  2/27 (7.41%) 
Psychiatric disorders     
Depression  1  1/4 (25.00%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/4 (25.00%)  2/27 (7.41%) 
Epistaxis  1  2/4 (50.00%)  4/27 (14.81%) 
Pleural effusion  1  1/4 (25.00%)  0/27 (0.00%) 
Pleuritic pain  1  1/4 (25.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/4 (0.00%)  2/27 (7.41%) 
Dermatitis exfoliative NOS  1  0/4 (0.00%)  2/27 (7.41%) 
Dermatology-Other  1  0/4 (0.00%)  2/27 (7.41%) 
Dry skin  1  0/4 (0.00%)  4/27 (14.81%) 
Pruritus  1  0/4 (0.00%)  2/27 (7.41%) 
Vascular disorders     
Hypertension  1  0/4 (0.00%)  7/27 (25.93%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peggy Romano, BA, CCRP
Organization: Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles
Phone: 323-361-5505
EMail: promano@chla.usc.edu
Layout table for additonal information
Responsible Party: Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier: NCT00440726    
Other Study ID Numbers: T2005-003
First Submitted: February 23, 2007
First Posted: February 27, 2007
Results First Submitted: October 2, 2018
Results First Posted: February 19, 2020
Last Update Posted: February 19, 2020