Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

January 15, 2013 updated by: National Cancer Institute (NCI)

The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia

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

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the feasibility of the addition of nelarabine to modified multiagent Berlin-Frankfurt-Muenster-86 chemotherapy in patients with newly diagnosed T-cell acute lymphoblastic leukemia.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics and intracellular pharmacology of nelarabine in these patients.

OUTLINE: This is a pilot, multicenter study.

Prednisone Response Pre-Induction: All patients receive oral prednisone three times daily on days -7 to -1 and methotrexate intrathecally (IT) on day -7* of week 0. Good prednisone responders proceed to induction on regimen A. Poor prednisone responders proceed to induction on regimen C.

NOTE: *Patients who have received cytarabine IT within the week prior to study entry receive methotrexate IT on day -6.

Regimen A (good prednisone responders) (closed as of 2/27/03):

Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone three times daily on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; asparaginase intramuscularly (IM) on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.

If bone marrow is M1, week 6 of induction therapy begins 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. Those patients with minimal residual disease (MRD) on day 36 proceed to regimen B.

Induction (weeks 6-9): Patients receive cyclophosphamide IV over 1 hour on days 36 and 63; cytarabine IV over 72 hours on days 38-40, 45-47, 52-54, and 59-61; oral mercaptopurine daily on days 36-63; and methotrexate IT on days 45 and 59.

Consolidation (weeks 10-19): Patients receive oral mercaptopurine on days 64-119; methotrexate IV over 24 hours and leucovorin calcium IV, or orally as tolerated, on days 71, 85, 99, and 113; and methotrexate IT on days 71, 85, 99, and 113. (Patients begin methotrexate once blood counts recover and only if bone marrow is M1).

Reinduction (weeks 20-29): Patients receive oral dexamethasone three times daily on days 134-154; vincristine IV on days 141 and 148; doxorubicin IV over 15 minutes on days 134, 141, 148, and 155; and asparaginase IM on days 141, 144, 148, 151, 154, and 157. Beginning on day 169 or when blood counts recover, patients receive cyclophosphamide IV on day 169, cytarabine IV over 72 hours on days 171-173 and 178-180; oral thioguanine daily on days 169-182; and methotrexate IT on days 171 and 178. Patients also receive cranial irradiation for up to 10 days beginning on day 189.

Maintenance (weeks 30-101): 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 9 courses.

Regimen B (patients with MRD on day 36 of regimen A) (closed as of 2/27/03):

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.

Regimen C (poor prednisone responders from stage 1 of study and all patients entered during stage 2 of study) (closed as of 2/27/03):

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.

Regimen D (effective 5/2004):

Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone 3 times a day on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; nelarabine IV over 1 hour on days 29-33; asparaginase IM on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.

Induction (weeks 6-9): Patients receive cyclophosphamide IV over 1 hour on days 36 and 50; cytarabine IV or SC on days 36-39, 43-46, 50-53, and 57-60; oral mercaptopurine once daily on days 36-63; and methotrexate IT on days 43 and 57.

Patients who are poor responders to prednisone in induction therapy proceed to regimen F. Patients who are good responders to prednisone but have MRD after induction therapy proceed to regimen E. Patients who are good responders to prednisone and have no MRD after induction therapy continue therapy on regimen D.

Consolidation (weeks 10-19): Patients must have M1 marrow to proceed. Patients receive oral mercaptopurine on days 70-126; methotrexate IV over 24 hours on days 77, 84, 91, and 98; leucovorin calcium IV or orally every 6 hours on days 78-79, 85-86, 92-93, and 99-100; and methotrexate IT on days 77, 84, 91, and 98.

Reinduction (weeks 20-29): Patients < 13 years old receive dexamethasone 3 times daily on days 140-161. Patients ≥ 13 years old receive oral dexamethasone on days 140-146 and 155-161; nelarabine IV on days 169-173; vincristine IV over 15 minutes on days 140, 147, and 153; pegaspargase IM on day 143; cyclophosphamide IV on day 176; cytarabine IV or SC on days 176-179 and 183-186; oral thioguanine on days 176-189; and methotrexate IT on days 176 and 183. Patients with CNS disease undergo craniocervical radiotherapy beginning on day 196 and continuing for 7-10 days.

Maintenance (weeks 30-61): Patients receive oral mercaptopurine on days 1-28 and 36-56; oral methotrexate on days 1, 8, 15, 22, 36, 43, and 50; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses.

Maintenance (weeks 62-101): Patients receive vincristine IV on day 1; oral dexamethasone twice daily on days 1-5; oral mercaptopurine on days 1-56; and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, and 50. Treatment repeats every 8 weeks for 5 courses.

Regimen E (good responders to induction prednisone but with MRD) (effective 5/2004): Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.

Regimen F (poor responders to induction prednisone) (effective 5/2004): Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients (30 for regimens A, B, and C; 70 for regimens D, E, and F) will be accrued for this study within 9-29 months.

Study Type

Interventional

Enrollment (Actual)

100

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Arcadia, California, United States, 91006-3776
    - Children's Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0 Time Frame: Up to 6 years	Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Kimberly Dunsmore, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2012-01857
U10CA098543 (U.S. NIH Grant/Contract)
COG-AALL00P2
CDR0000068620 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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