Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia
NCT00016302CI-TRIAL-00008959completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-cell Childhood Acute Lymphoblastic Leukemia | Childhood T Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Untreated Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (17)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| asparaginase | Drug | Asparaginase | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Regimen A
- description
- See detailed description.
- interventionNames
- 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
- Other: pharmacological study
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Regimen B
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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 allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.