Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016302
First received: May 6, 2001
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia


Condition Intervention
T-cell Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Drug: prednisone
Drug: vincristine sulfate
Drug: daunorubicin hydrochloride
Drug: asparaginase
Drug: methotrexate
Drug: cyclophosphamide
Drug: cytarabine
Drug: mercaptopurine
Drug: leucovorin calcium
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: thioguanine
Radiation: radiation therapy
Drug: nelarabine
Drug: pegaspargase
Other: pharmacological study
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: April 2001
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A
See detailed description.
Drug: prednisone
Given orally
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: methotrexate
Given IT and orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cytarabine
Given IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: dexamethasone
Given orally
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: thioguanine
Given orally
Other Name: 6-TG
Radiation: radiation therapy
Undergo cranial irradiation
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Regimen B

Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.

Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.

Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.

Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.

Drug: prednisone
Given orally
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: methotrexate
Given IT and orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cytarabine
Given IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: dexamethasone
Given orally
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: thioguanine
Given orally
Other Name: 6-TG
Radiation: radiation therapy
Undergo cranial irradiation
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Regimen C

Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.

If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.

Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.

Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.

Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.

Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.

Drug: prednisone
Given orally
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: methotrexate
Given IT and orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cytarabine
Given IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: dexamethasone
Given orally
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: thioguanine
Given orally
Other Name: 6-TG
Radiation: radiation therapy
Undergo cranial irradiation
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Regimen D
See detailed description.
Drug: prednisone
Given orally
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: methotrexate
Given IT and orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cytarabine
Given IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: dexamethasone
Given orally
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
Drug: prednisone
Given orally
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: methotrexate
Given IT and orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cytarabine
Given IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: dexamethasone
Given orally
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
Drug: prednisone
Given orally
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: methotrexate
Given IT and orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cytarabine
Given IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: dexamethasone
Given orally
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)

    • High-risk disease, defined as meeting at least 1 of the following criteria:

      • WBC at least 50,000/mm^3
      • Age 10 years or over
  • Patients with WBC at least 25,000/mm^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
  • Concurrent registration to POG 9900 within the past 8 days required
  • Performance status - Karnofsky 50-100% (over 10 years of age)
  • Performance status - Lansky 50-100% (10 years of age and under)
  • See Disease Characteristics
  • Bilirubin no greater than 1.5 mg/dL
  • SGPT less than 5 times normal
  • Creatinine normal
  • Creatinine clearance or glomerular filtration rate at least 60 mL/min
  • No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior biologic therapy
  • No more than 72 hours since prior intrathecal cytarabine
  • No other prior chemotherapy
  • Prior steroids allowed
  • No chronic steroid treatment for another disease
  • Prior emergency radiotherapy to mediastinum for severe respiratory distress allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016302

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Investigators
Principal Investigator: Kimberly Dunsmore Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016302     History of Changes
Other Study ID Numbers: NCI-2012-01857, COG-AALL00P2, U10CA098543, CDR0000068620
Study First Received: May 6, 2001
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014