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Trial record 16 of 16 for:    "Acute T Cell Leukemia" | "Autonomic Agents"

Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT01005914
Recruitment Status : Terminated (Increased rate of bacterial infections)
First Posted : November 2, 2009
Results First Posted : February 11, 2015
Last Update Posted : March 4, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: imatinib mesylate
Drug: methotrexate
Drug: methylprednisolone
Drug: pegaspargase
Drug: vincristine sulfate
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1
Hide Arm/Group Description

Drug:cyclophosphamide-Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 & 11: 2 mg IV

cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3

cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4

dexamethasone: Day 1-4; 11-14: 40 mg daily

doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours

imatinib mesylate: 600 mg/day

methotrexate: D

Period Title: Overall Study
Started 11
Completed 1
Not Completed 10
Reason Not Completed
Adverse Event             4
Death             4
Lack of Efficacy             1
Withdrawal by Subject             1
Arm/Group Title Group 1
Hide Arm/Group Description

Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily

Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours

Drug:imatinib mesylate 600 mg/day

Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion

Drug: methylprednisolone Day 1-3: 50mg IV BID

Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV

Drug: vincristine sulfate Day 4 & 11: 2 mg IV

cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3

cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4

dexamethasone: Day 1-4; 11-14: 40 mg daily

doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours

imatinib mesylate: 600 mg/day

methotrexate: D

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
Analysis was not performed due to early termination of the study due to safety concerns.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
42.9
(22 to 60)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen
Hide Description The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.
Time Frame After day 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measure analysis was not performed due to early termination of the study due to safety concerns
Arm/Group Title Group 1
Hide Arm/Group Description:
Cy D1- 3: 300 m g/m2 IV- 6 doses, mesna 600 mg/ m2 /day continuous IV D 1-3, ARAC D 2 & 3: 3g/m2 IV q12 X 4, Dex D1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV, imatinib mesylate 600 mg/day, MTX D1: 1g/ m2 200 mg/ m2 load IV plus 800 mg/ m2, methylprednisolone D 1-3: 50mg IV BID, pegaspargase D3/D4: 2,500 IU/ m2 IV, vincristine sulfate D4 & 11: 2 mg IV, Cy: D 1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day, continuous infusion D 1-3. ARAC D 2 & 3: 3g/m2 IV q12 X 4, dex: D 1-4; 11-14: 40 mg daily, doxorubicin hydrochloride: D 4: 50 mg/m2 IV, imatinib mesylate: 600 mg/day, MTX: D 1: 1g/ m2 200 mg/ m2load IV plus 800 mg/ m2 IV, methylprednisolone: D 1-3: 50mg IV BID, pegaspargase: D 3/D4: 2,500 IU/ m2 IV, vincristine sulfate: D 4 & 11: 2 mg IV, pharmacological study: C1A: pre-dose between Days 1 to 4, C1A: D11 or 12., C1A: D18 or 19, C 1A: D25 or 26, C1A: D32 or 33 C1B: pre-dose between D1-3, C1B: D1 or 11 C1B: D17 or 18, C1B: D24 or 25 C1B: D31 or 32
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.
Hide Description [Not Specified]
Time Frame The assessment of safety will be based mainly on the frequency of adverse events
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 2-year Progression-free Survival
Hide Description [Not Specified]
Time Frame After completion of 8 cycles
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2
Hide Description [Not Specified]
Time Frame An interim analysis of safety is planned after the enrollment of 15 evaluable patients.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame At least every 6 months until death.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Rate of Minimal Residual Disease
Hide Description Cycle 1A: Days 1 through 14 Cycle 1B: Days 1 through 8, after the first 14 days of cycle 1A
Time Frame End of cycles 1A and 1B
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Half-life of Pegaspargase
Hide Description [Not Specified]
Time Frame The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.
Outcome Measure Data Not Reported
Time Frame All unexpected adverse events (AEs) related, probably related or possibly related to the study drug which are equal or greater than Grade 3 and serious adverse events (SAEs) were collected from first patient enrollment on 10/21/09 through 2010.
Adverse Event Reporting Description

Adverse events collected:

  1. Unexpected AEs (when type or severity isn't listed in Expected AE List)
  2. Deaths within 30 days of drug admin.
  3. Grade ≥ 3 (related to the following):

    • Allergic reactions
    • CNS thrombosis/embolism
    • Coagulopathy
    • Elevated AST, ALT
    • Hyperbilirubinemia
    • Hyperglycemia
    • Hypertriglyceridemia
    • Pancreatitis
 
Arm/Group Title Group 1
Hide Arm/Group Description

cyclophosphamide D1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day cont. IV D1-3, cytarabine D2 & 3: 3g/m2 IV, dexD1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV

Drug:imatinib mesylate 600 mg/day

Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion

Drug: methylprednisolone Day 1-3: 50mg IV BID

Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV

Drug: vincristine sulfate Day 4 & 11: 2 mg IV

cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3

cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4

dexamethasone: Day 1-4; 11-14: 40 mg daily

doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours

imatinib mesylate: 600 mg/day

methotrexate: D

All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%) # Events
Total   9/11 (81.82%)    
Blood and lymphatic system disorders   
neutropenic fever   4/11 (36.36%)  7
hypokalemia, hyponatremia   1/11 (9.09%)  2
Cardiac disorders   
Chest pain   1/11 (9.09%)  1
Cardiac Arrest   1/11 (9.09%)  1
Gastrointestinal disorders   
Abdominal pain   1/11 (9.09%)  1
gastoenteritis   1/11 (9.09%)  1
General disorders   
Death   1/11 (9.09%)  1
Immune system disorders   
anaphylaxis   1/11 (9.09%)  1
Infections and infestations   
Bacillus species sepsis with encephalitis   1/11 (9.09%)  1
Septic shock   2/11 (18.18%)  2
fungemia, staph bacteremia   1/11 (9.09%)  1
gnr bacteremia   1/11 (9.09%)  1
acute epiglottitis   1/11 (9.09%)  1
klebsiella bacteremia   1/11 (9.09%)  1
pneumonia (streptoccocus bacteremia)   1/11 (9.09%)  1
lung infection (fungal)   1/11 (9.09%)  1
alpha-hemolytic streptococcal bacteremia   1/11 (9.09%)  1
Vascular disorders   
Pulmonary embolism   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Early termination of the study due to adverse events.
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. Brandon Hayes-Lattin
Organization: Oregon Health & Science University
Phone: 503-494-1551
EMail: hayeslat@ohsu.edu
Layout table for additonal information
Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01005914     History of Changes
Other Study ID Numbers: CDR0000642363
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-4913 ( Other Identifier: OHSU IRB )
ENZON-OHSU-4913 ( Other Identifier: OHSU )
First Submitted: October 30, 2009
First Posted: November 2, 2009
Results First Submitted: October 28, 2014
Results First Posted: February 11, 2015
Last Update Posted: March 4, 2015