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Trial record 82 of 138 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Immunologic Factors"

S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00337168
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : July 10, 2012
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: clofarabine
Drug: cytarabine
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction
Hide Arm/Group Description Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
Period Title: Overall Study
Started 37
Eligible 37
Eligible and Treated 36
Completed 29
Not Completed 8
Reason Not Completed
Death             5
Not protocol specified             2
Did not start therapy             1
Arm/Group Title Induction
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
41
(20 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
13
  36.1%
Male
23
  63.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Number of Patients With Complete Remission
Hide Description Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease
Time Frame Between day 28 and day 35 inclusive
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started therapy
Arm/Group Title Induction
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title Expression of Nucleoside Transporters
Hide Description Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.
Time Frame On average, two weeks before treatment started
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who submitted paraffin-embedded tissue
Arm/Group Title Induction
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
High expression of hENT1 7
High expression of hCNT3 6
High expression of dCK cytoplasmic 4
High expression of dCK nuclear 4
3.Secondary Outcome
Title Number of Patients With Very Poor Risk Cytogenetics
Hide Description [Not Specified]
Time Frame On average, 2 weeks before treatment started
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with acceptable centrally reviewed cytogenetics
Arm/Group Title Induction
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
10
4.Secondary Outcome
Title Toxicity
Hide Description Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Time Frame Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started therapy
Arm/Group Title Induction
Hide Arm/Group Description:
Up to two induction cycles with clofarabine and cytarabine
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: Participants with a given type of AE
ALT, SGPT (serum glutamic pyruvic transaminase) 5
AST, SGOT (serum glut oxaloacetic transaminase) 7
Albumin, serum-low (hypoalbuminemia) 3
Anorexia 1
Ascites (non-malignant) 2
Bilirubin (hyperbilirubinemia) 3
Calcium, serum-low (hypocalcemia) 1
Colitis 1
Colitis, infectious (e.g., Clostridium difficile) 2
Confusion 1
Creatinine 4
DIC (disseminated intravascular coagulation) 1
Death not assoc with CTCAE term-Multi-organ fail 1
Dermatology/Skin-Other (Specify) 1
Diarrhea 2
Dyspnea (shortness of breath) 1
Edema: limb 1
Fatigue (asthenia, lethargy, malaise) 2
Febrile neutropenia 14
Glucose, serum-high (hyperglycemia) 1
Hemoglobin 13
Hypotension 3
Hypoxia 1
INR 1
Infec with Gr 3\4 neutrophils - Bladder (urin 1
IInfec with Gr 3\4 neutrophils - Blood 9
Infec with Gr 3\4 neutrophils - Catheter-rela 1
Infec with Gr 3\4 neutrophils - Colon 2
Infec with Gr 3\4 neutrophils - Conjunctiva 1
Infec with Gr 3\4 neutrophils - Larynx 1
Infec with Gr 3\4 neutrophils - Lung (pneumon 2
Infec with Gr 3\4 neutrophils - Skin (celluli 1
Infec with Gr 3\4 neutrophils - Urinary tract 1
Infec with Gr 3\4 neutrophils - Wound 1
Infection with unknown ANC - Lung (pneumonia) 1
Infection-Other (Specify) 1
Leukocytes (total WBC) 11
Liver dysfunction/failure (clinical) 1
Lymphopenia 7
Mental status 1
Neutrophils/granulocytes (ANC/AGC) 18
PTT (Partial thromboplastin time) 1
Pain - Abdomen NOS 1
Pain - Back 1
Pain - Bone 1
Platelets 20
Pleural effusion (non-malignant) 1
Pneumonitis/pulmonary infiltrates 1
Potassium, serum-high (hyperkalemia) 1
Potassium, serum-low (hypokalemia) 4
Pruritus/itching 1
Renal failure 3
Restrictive cardiomyopathy 1
Sodium, serum-high (hypernatremia) 1
Sodium, serum-low (hyponatremia) 2
Supraventricular and nodal arrhythmia 1
Tumor lysis syndrome 1
Typhlitis (cecal inflammation) 1
Uric acid, serum-high (hyperuricemia) 1
Time Frame While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Adverse Event Reporting Description Regular investigator assessments are reported after each cycle of protocol treatment
 
Arm/Group Title Induction
Hide Arm/Group Description Up to two induction cycles with clofarabine and cytarabine
All-Cause Mortality
Induction
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Induction
Affected / at Risk (%)
Total   5/36 (13.89%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/36 (2.78%) 
Gastrointestinal disorders   
Colitis  1  1/36 (2.78%) 
General disorders   
Death not associated with CTCAE term - Multi-organ failure  1  1/36 (2.78%) 
Infections and infestations   
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood  1  1/36 (2.78%) 
Renal and urinary disorders   
Renal failure  1  1/36 (2.78%) 
Vascular disorders   
Hypotension  1  1/36 (2.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction
Affected / at Risk (%)
Total   31/36 (86.11%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  14/36 (38.89%) 
Hemoglobin  1  18/36 (50.00%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia - Sinus tachycardia  1  3/36 (8.33%) 
Gastrointestinal disorders   
Ascites (non-malignant)  1  2/36 (5.56%) 
Constipation  1  3/36 (8.33%) 
Diarrhea  1  11/36 (30.56%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  2/36 (5.56%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  2/36 (5.56%) 
Nausea  1  17/36 (47.22%) 
Pain - Abdomen NOS  1  6/36 (16.67%) 
Typhlitis (cecal inflammation)  1  2/36 (5.56%) 
Vomiting  1  5/36 (13.89%) 
General disorders   
Edema: limb  1  6/36 (16.67%) 
Fatigue (asthenia, lethargy, malaise)  1  10/36 (27.78%) 
Rigors/chills  1  3/36 (8.33%) 
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  2/36 (5.56%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood  1  9/36 (25.00%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon  1  2/36 (5.56%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon  1  3/36 (8.33%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  11/36 (30.56%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  11/36 (30.56%) 
Alkaline phosphatase  1  5/36 (13.89%) 
Bilirubin (hyperbilirubinemia)  1  10/36 (27.78%) 
Creatinine  1  7/36 (19.44%) 
INR (International Normalized Ratio of prothrombin time)  1  2/36 (5.56%) 
Leukocytes (total WBC)  1  11/36 (30.56%) 
Lymphopenia  1  7/36 (19.44%) 
Metabolic/Laboratory-Other (Specify)  1  2/36 (5.56%) 
Neutrophils/granulocytes (ANC/AGC)  1  18/36 (50.00%) 
PTT (Partial thromboplastin time)  1  3/36 (8.33%) 
Platelets  1  20/36 (55.56%) 
Weight loss  1  2/36 (5.56%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  9/36 (25.00%) 
Anorexia  1  5/36 (13.89%) 
Calcium, serum-low (hypocalcemia)  1  7/36 (19.44%) 
Glucose, serum-high (hyperglycemia)  1  4/36 (11.11%) 
Magnesium, serum-low (hypomagnesemia)  1  2/36 (5.56%) 
Potassium, serum-high (hyperkalemia)  1  3/36 (8.33%) 
Potassium, serum-low (hypokalemia)  1  9/36 (25.00%) 
Sodium, serum-low (hyponatremia)  1  5/36 (13.89%) 
Musculoskeletal and connective tissue disorders   
Pain - Back  1  3/36 (8.33%) 
Pain - Bone  1  3/36 (8.33%) 
Nervous system disorders   
Pain - Head/headache  1  10/36 (27.78%) 
Psychiatric disorders   
Confusion  1  4/36 (11.11%) 
Insomnia  1  4/36 (11.11%) 
Mood alteration - depression  1  2/36 (5.56%) 
Renal and urinary disorders   
Renal failure  1  2/36 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/36 (8.33%) 
Dyspnea (shortness of breath)  1  3/36 (8.33%) 
Hiccoughs (hiccups, singultus)  1  2/36 (5.56%) 
Pain - Throat/pharynx/larynx  1  2/36 (5.56%) 
Pneumonitis/pulmonary infiltrates  1  2/36 (5.56%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify)  1  4/36 (11.11%) 
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  2/36 (5.56%) 
Rash/desquamation  1  6/36 (16.67%) 
Rash: hand-foot skin reaction  1  3/36 (8.33%) 
Sweating (diaphoresis)  1  3/36 (8.33%) 
Vascular disorders   
Hypotension  1  3/36 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: SWOG Leukemia Statistician
Organization: SWOG Statistical Office
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00337168     History of Changes
Other Study ID Numbers: S0530
U10CA032102 ( U.S. NIH Grant/Contract )
SWOG-S0530 ( Other Identifier: SWOG )
First Submitted: June 13, 2006
First Posted: June 15, 2006
Results First Submitted: June 5, 2012
Results First Posted: July 10, 2012
Last Update Posted: March 25, 2015