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

This study has been terminated.
(Increased rate of bacterial infections)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01005914
First received: October 30, 2009
Last updated: February 12, 2015
Last verified: February 2015
Results First Received: October 28, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1

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


Participant Flow:   Overall Study
    Group 1  
STARTED     11  
COMPLETED     1  
NOT COMPLETED     10  
Adverse Event                 4  
Death                 4  
Lack of Efficacy                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was not performed due to early termination of the study due to safety concerns.

Reporting Groups
  Description
Group 1

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


Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Mean (Full Range)
  42.9    (22 to 60)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     5  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures

1.  Primary:   Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen   [ Time Frame: After day 4 of treatment ]

2.  Primary:   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.   [ Time Frame: The assessment of safety will be based mainly on the frequency of adverse events ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   2-year Progression-free Survival   [ Time Frame: After completion of 8 cycles ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2   [ Time Frame: An interim analysis of safety is planned after the enrollment of 15 evaluable patients. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Overall Survival   [ Time Frame: At least every 6 months until death. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Rate of Minimal Residual Disease   [ Time Frame: End of cycles 1A and 1B ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Half-life of Pegaspargase   [ 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. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of the study due to adverse events.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Brandon Hayes-Lattin
Organization: Oregon Health & Science University
phone: 503-494-1551
e-mail: hayeslat@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01005914     History of Changes
Other Study ID Numbers: CDR0000642363, P30CA069533, OHSU-4913, ENZON-OHSU-4913
Study First Received: October 30, 2009
Results First Received: October 28, 2014
Last Updated: February 12, 2015
Health Authority: United States: Food and Drug Administration