Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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| ClinicalTrials.gov Identifier: NCT00016302 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
- Study Details
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | April 2001 |
| Actual Primary Completion Date : | July 2007 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
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 |
Primary Outcome Measures :
- Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0 [ Time Frame: Up to 6 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
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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
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- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016302
Locations
| United States, California | |
| Children's Oncology Group | |
| Arcadia, California, United States, 91006-3776 | |
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Kimberly Dunsmore | Children's Oncology Group |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016302 |
| Other Study ID Numbers: |
NCI-2012-01857 COG-AALL00P2 U10CA098543 ( U.S. NIH Grant/Contract ) CDR0000068620 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | January 16, 2013 |
| Last Verified: | January 2013 |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leucovorin Cytarabine Dexamethasone Prednisone Cyclophosphamide Doxorubicin |
Liposomal doxorubicin Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Pegaspargase Thioguanine Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |