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EZN-2285 or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Sigma Tau Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00671034
First received: May 1, 2008
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized clinical trial is studying giving EZN-2285 together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia.


Condition Intervention
Leukemia
 Drug: calaspargase pegol
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Pharmacokinetics of SC-PEG E. coli L-asparaginase (EZN-2285) compared to pegaspargase during induction and consolidation therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine the PK of EZN-2285 and Oncaspar® during Induction and during Consolidation therapy in patients with high-risk ALL receiving augmented BFM therapy and receiving EZN-2285 or Oncaspar®.


Secondary Outcome Measures:
  • Pharmacodynamics of EZN-2285 compared to pegaspargase during induction and consolidation therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Pharmacodynamics of EZN-2285 and of Oncaspar® during Induction and during Consolidation will be assessed.

  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    End of Induction therapy Day 29 MRD results as well as the response rates of the EZN-2285 containing regimen and the Oncaspar® containing regimen also be assessed.

  • Event-free survival [ Time Frame: from the date of diagnosis to the date of the first documented progression/relapse event, (including Induction failure), diagnosis of a second malignant neoplasm, or death from any cause ] [ Designated as safety issue: No ]
    Estimates of median EFS and the corresponding 95% CI will be calculated after minimum follow-up of 3 years


Estimated Enrollment: 318
Study Start Date: July 2008
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive SC-PEG E. coli L-asparaginase (EZN-2285) together with combination chemotherapy. Patients receive chemotherapy by mouth, infusion, injection, and intrathecally. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years. (As of 12/22/2010, patients do not receive EZN-2285. They receive pegaspargase as in arm II.) (As of amendment #6, patients receive EZN-2285 again.)
 Drug: calaspargase pegol
Given IV
Other Names:
  • CALASPARGASE PEGOL
  • EZN-2285
  • SC-PEG E. coli L-asparaginase
  • IND# 100594
Drug: cyclophosphamide
All drugs are given IV
Drug: cytarabine
Given IV, intrathecally, and subcutaneously
Drug: daunorubicin hydrochloride
All drugs are given IV
Drug: dexamethasone
Both are given IV or orally
Drug: doxorubicin hydrochloride
All drugs are given IV
Drug: methotrexate
Given IV, intrathecally, and orally
Drug: prednisone
Both are given IV or orally
Drug: vincristine sulfate
All drugs are given IV
Radiation: radiation therapy
Some patients undergo cranial radiotherapy
Active Comparator: Arm II
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy by mouth, infusion, injection, and intrathecally. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.
 Drug: cyclophosphamide
All drugs are given IV
Drug: cytarabine
Given IV, intrathecally, and subcutaneously
Drug: daunorubicin hydrochloride
All drugs are given IV
Drug: dexamethasone
Both are given IV or orally
Drug: doxorubicin hydrochloride
All drugs are given IV
Drug: methotrexate
Given IV, intrathecally, and orally
Drug: pegaspargase
Given IV
Drug: prednisone
Both are given IV or orally
Drug: vincristine sulfate
All drugs are given IV
Radiation: radiation therapy
Some patients undergo cranial radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed high-risk B lymphoblastic leukemia (WHO 2008 classification) (also termed B-precursor acute lymphoblastic leukemia
  • No Down syndrome
  • No testicular leukemia
  • Enrolled on COG-AALL08B1 study or the successor classification study
  • Enrolled on COG-AALL07P4 study before systemic treatment begins

PATIENT CHARACTERISTICS:

  • WBC ≥ 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior cytotoxic chemotherapy except for steroid therapy or intrathecal cytarabine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671034

  Show 25 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Sigma Tau Pharmaceuticals, Inc.
Investigators
Study Chair: Anne Angiolillo, MD Children's Research Institute
Principal Investigator: Taha Keilani, MD Sigma Tau Pharmaceuticals, Inc.
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00671034     History of Changes
Other Study ID Numbers: AALL07P4, CDR0000594340, NCI-2009-00317, COG-AALL07P4
Study First Received: May 1, 2008
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
B-cell adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
 Doxorubicin
Methotrexate
Prednisone
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 23, 2013