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CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00176462
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphocytic Leukemia
Interventions Drug: aminopterin
Drug: L-asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunomycin
Drug: dexamethasone
Drug: 6-mercaptopurine
Drug: methotrexate
Drug: 6-thioguanine
Drug: vincristine
Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)
Drug: Leucovorin
Enrollment 60
Recruitment Details 59 patients with ALL were enrolled between March, 2001 and September, 2005 at the Cancer Institute of New Jersey (outpatient clinical research facility) and 1 patient was enrolled at Jersey Shore University Medical Center (a community hospital).
Pre-assignment Details  
Arm/Group Title Arm 1 Standard Risk Arm 2 High Risk
Hide Arm/Group Description 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
Period Title: Induction (4 Weeks)
Started 21 39
Completed 20 34
Not Completed 1 5
Reason Not Completed
Withdrawal by Subject             0             2
Death             1             2
Lack of Efficacy             0             1
Period Title: Consolidation (12 Weeks)
Started 20 34
Completed 20 29
Not Completed 0 5
Reason Not Completed
Patient moved to another state             0             1
Adverse Event             0             1
Lack of Efficacy             0             2
Not documented             0             1
Period Title: Delayed Intensification (8 Weeks)
Started 20 29
Completed 20 29
Not Completed 0 0
Period Title: Intensive Continuation (8X8-week Cycles)
Started 20 29
Completed 19 26
Not Completed 1 3
Reason Not Completed
Death             1             0
Lack of Efficacy             0             3
Period Title: Continuation -up to 30mos Post Remission
Started 19 26
Completed 19 26
Not Completed 0 0
Arm/Group Title Arm 1 Standard Risk Arm 2 High Risk Total
Hide Arm/Group Description 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C Total of all reporting groups
Overall Number of Baseline Participants 21 39 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 39 participants 60 participants
<=18 years
21
 100.0%
30
  76.9%
51
  85.0%
Between 18 and 65 years
0
   0.0%
9
  23.1%
9
  15.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 39 participants 60 participants
3.71  (1.77) 16  (9.8) 11.7  (9.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 39 participants 60 participants
Female
11
  52.4%
18
  46.2%
29
  48.3%
Male
10
  47.6%
21
  53.8%
31
  51.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 39 participants 60 participants
21 39 60
1.Primary Outcome
Title Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years
Hide Description This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of high risk ALL patients treated.
Arm/Group Title Arm 2 High Risk
Hide Arm/Group Description:
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
64.9
2.Secondary Outcome
Title To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.
Arm/Group Title Arm 1 Standard Risk Arm 2 High Risk
Hide Arm/Group Description:
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 7 years, 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Standard Risk Arm 2 High Risk
Hide Arm/Group Description 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
All-Cause Mortality
Arm 1 Standard Risk Arm 2 High Risk
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Standard Risk Arm 2 High Risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/21 (95.24%)      36/39 (92.31%)    
Blood and lymphatic system disorders     
Platelets * 1  5/21 (23.81%)  5 5/39 (12.82%)  7
Hypokalemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hemoglobin * 1  1/21 (4.76%)  1 3/39 (7.69%)  4
Fibrinogen * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Leukocytes (total WBC) - Neutropenia * 1  0/21 (0.00%)  0 3/39 (7.69%)  4
Hyperglycemia * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Hyperbilirubinemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hypoalbuminemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Neutrophils/granulocytes (ANC/AGC) * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Cardiac disorders     
Cardiac troponin I * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Gastrointestinal disorders     
Dehydration * 1  0/21 (0.00%)  0 3/39 (7.69%)  3
Vomiting * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Abdominal pain or cramping * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Stomatitis / pharyngitis * 1  0/21 (0.00%)  0 2/39 (5.13%)  3
Pancreatitis * 1  1/21 (4.76%)  1 1/39 (2.56%)  1
Typhlitis (inflammation of cecum) * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Diarrhea * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
General disorders     
Thrombosis/embolism * 1  1/21 (4.76%)  1 1/39 (2.56%)  1
Fever * 1 [1]  1/21 (4.76%)  1 1/39 (2.56%)  2
Anorexia * 1  0/21 (0.00%)  0 3/39 (7.69%)  3
Fatigue * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Syncope * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Infections and infestations     
Febrile neutropenia * 1  16/21 (76.19%)  29 17/39 (43.59%)  35
Infection with unknown ANC * 1  1/21 (4.76%)  1 3/39 (7.69%)  3
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia * 1  1/21 (4.76%)  1 2/39 (5.13%)  2
Infection without neutropenia * 1  3/21 (14.29%)  3 1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders     
Muscle weakness (not due to neuropathy) * 1  0/21 (0.00%)  0 5/39 (12.82%)  7
Joint pain * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Muscle Pain * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Bone pain * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Osteonecrosis * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Relapsed leukemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Nervous system disorders     
Neurology * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Neuropathy * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Neuropathic pain * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Psychiatric disorders     
Psychosis * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Renal and urinary disorders     
Melena/GI bleeding - Hemorrhage * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Renal failure * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  2/21 (9.52%)  2 1/39 (2.56%)  1
Pneumonitis/pulmonary infiltrates * 1  3/21 (14.29%)  4 2/39 (5.13%)  2
Cough * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Broncohspasm * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hypoxia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Pleural effusion * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Skin and subcutaneous tissue disorders     
Allergic reaction/hypersensitivity * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Rash/desquamation * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Vascular disorders     
DIC (disseminated intravascular coagulation) * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Arm 1 Standard Risk Arm 2 High Risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/21 (100.00%)      39/39 (100.00%)    
Blood and lymphatic system disorders     
Platelets * 1  1/21 (4.76%)  1 3/39 (7.69%)  4
Pancytopenia * 1  0/21 (0.00%)  0 3/39 (7.69%)  4
Hypokalemia * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Hemoglobin * 1  2/21 (9.52%)  3 0/39 (0.00%)  0
Hyperammonemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hyperglycemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hypercalcemia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hyperbilirubinemia * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Cardiac disorders     
Tachycardia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Ventricular arrythmia * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Hypotension * 1  1/21 (4.76%)  1 1/39 (2.56%)  1
Ear and labyrinth disorders     
Otitis middle ear * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Gastrointestinal disorders     
Dehydration * 1  1/21 (4.76%)  1 5/39 (12.82%)  6
Nausea * 1  0/21 (0.00%)  0 3/39 (7.69%)  9
Vomiting * 1  2/21 (9.52%)  2 7/39 (17.95%)  17
Gastritis * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Abdominal pain or cramping * 1  1/21 (4.76%)  1 4/39 (10.26%)  4
Stomatitis / pharyngitis * 1  1/21 (4.76%)  1 4/39 (10.26%)  5
Appendicitis * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Bowel obstruction * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Pancreatitis * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Weight gain * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
GI other (Elevated liver enzymes) * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Diarrhea * 1  0/21 (0.00%)  0 1/39 (2.56%)  2
Excessive thirst * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Amylase * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
General disorders     
Fever * 1  12/21 (57.14%)  22 15/39 (38.46%)  21
Headache - Pain-Head * 1  0/21 (0.00%)  0 7/39 (17.95%)  10
Other Toxicity * 1  3/21 (14.29%)  3 5/39 (12.82%)  5
Chest pain * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Pain * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Rigors * 1  0/21 (0.00%)  0 1/39 (2.56%)  2
Immune system disorders     
Allergic reaction/hypersensitivity * 1  3/21 (14.29%)  4 0/39 (0.00%)  0
Infections and infestations     
Infection with unknown ANC * 1  1/21 (4.76%)  1 4/39 (10.26%)  4
Infection without neutropenia * 1  1/21 (4.76%)  1 1/39 (2.56%)  1
Infection / Febrile neutropenia * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Extremity pain * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Joint pain * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Muscle Pain * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Fracture * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ascites * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Nervous system disorders     
Neuropathy * 1  0/21 (0.00%)  0 3/39 (7.69%)  3
Speech impairment * 1  0/21 (0.00%)  0 1/39 (2.56%)  3
Seizure(s) * 1  0/21 (0.00%)  0 1/39 (2.56%)  2
Neurology - Mood Alteration * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Renal and urinary disorders     
Urinary freqency * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/21 (0.00%)  0 2/39 (5.13%)  2
Rhinitis * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Upper respiratory infection * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Edema (Pulmonary) * 1  1/21 (4.76%)  2 0/39 (0.00%)  0
Tachypnea * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Pneumothorax * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Wheezing * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Fever & pneumonia * 1  1/21 (4.76%)  1 0/39 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash/desquamation * 1  1/21 (4.76%)  1 1/39 (2.56%)  1
Phlebitis (superficial) * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
Vascular disorders     
Cerebrovascular accident * 1  0/21 (0.00%)  0 1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Antifolate therapy was non-randomly assigned, therefore, we do not have a statistical basis to compare the toxicity observed among patients on the standard risk and high risk treatment arms.
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: Richard Drachtman, MD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: drachtri@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00176462     History of Changes
Other Study ID Numbers: 020101
0220003389 ( Other Identifier: IRB Number )
P30CA072720 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: November 15, 2013
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014