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

Sponsor:	Children's Oncology Group
Collaborators:	National Cancer Institute (NCI) Sigma Tau Pharmaceuticals, Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00671034

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 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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Dexamethasone Cyclophosphamide Prednisone Vincristine Methotrexate Cytarabine hydrochloride Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Pegaspargase Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate L-Asparaginase

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pharmacokinetics of SC-PEG E. coli L-asparaginase (EZN-2285) compared to pegaspargase during induction and consolidation therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamics of EZN-2285 compared to pegaspargase during induction and consolidation therapy [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]
Minimal residual disease at day 29 of induction therapy [ Designated as safety issue: No ]
Complete remission rates [ Designated as safety issue: No ]
Immunogenicity of EZN-2285 compared to pegaspargase [ Designated as safety issue: No ]
Toxicities [ Designated as safety issue: Yes ]

Estimated Enrollment:	318
Study Start Date:	July 2008
Estimated Primary Completion Date:	March 2018 (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 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

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

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

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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

ClinicalTrials.gov Identifier:	NCT00671034 History of Changes
Other Study ID Numbers:	CDR0000594340, COG-AALL07P4
Study First Received:	May 1, 2008
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

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 February 12, 2012