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
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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:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Prednisone
Methotrexate
Cytarabine
Thioguanine
Dexamethasone acetate
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Asparaginase
Sulfate ion
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Levoleucovorin
Nelarabine
Pegaspargase
Daunorubicin citrate
U.S. FDA Resources
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:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: methotrexate
Given IT and orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV or SC
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Radiation: radiation therapy
Undergo cranial irradiation
Other Names:
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:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: methotrexate
Given IT and orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV or SC
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Radiation: radiation therapy
Undergo cranial irradiation
Other Names:
Drug: nelarabine
Given IV
Other Names:
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:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: methotrexate
Given IT and orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV or SC
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Radiation: radiation therapy
Undergo cranial irradiation
Other Names:
Drug: nelarabine
Given IV
Other Names:
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
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:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: methotrexate
Given IT and orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV or SC
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: nelarabine
Given IV
Other Names:
Drug: pegaspargase
Given IM
Other Names:
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
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:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: methotrexate
Given IT and orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV or SC
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: nelarabine
Given IV
Other Names:
Drug: pegaspargase
Given IM
Other Names:
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
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:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: asparaginase
Given IM
Other Names:
Drug: methotrexate
Given IT and orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV or SC
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: dexamethasone
Given orally
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: nelarabine
Given IV
Other Names:
Drug: pegaspargase
Given IM
Other Names:
Radiation: radiation therapy
Undergo craniocervical radiotherapy
Other Names:
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 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:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Pegaspargase |
Asparaginase Daunorubicin Dexamethasone Doxorubicin Prednisone Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013