Clinical trial · Interventional
S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), and giving the drugs in different combinations may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (17)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allopurinol | Drug | — | UNRESOLVED |
| Asparaginase | Drug | Asparaginase | ALIAS |
| bactrim | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| filgrastim |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induc x2, Consol, Maint
- description
- Induc 1: Allopurinol; Daunorubicin; Vincristine; Prednisone; asparaginase; Bactrim Induc 2: Allopurinol; cytarabine; Dexamethasone; filgrastim; mitoxantrone; Methotrexate; leucovorin Consol: Cyclophosphamide; cytarabine; 6-mercaptopurine; Methotrexate; filgrastim Maint:Course 1: 6-mercaptopurine; Methotrexate Course 2: Vincristine; doxorubicin; Dexamethasone Course 3: Cyclophosphamidee; thioguanine; cytarabine Course 4: 6-mercaptopurine; methotrexate
- interventionNames
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: daunorubicin
- Drug: dexamethasone
- Drug: doxorubicin
- Drug: leucovorin
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: mitoxantrone
- Drug: Asparaginase
- Drug: prednisone
- Drug: thioguanine
- Drug: vincristine
- Radiation: radiation therapy
- Drug: allopurinol
- Drug: bactrim
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologically confirmed acute lymphoblastic leukemia (ALL), meeting any of the following criteria: * FAB class L1 or L2 disease * Mixed lineage ALL * Ph-negative/BCR/ABL-negative * Newly diagnosed disease * Patients with the following diagnoses are not eligible: * FAB class L3 ALL * Non-Hodgkin's lymphoma * Chronic myelogenous leukemia in lymphoid blast crisis * Mixed lineage acute myeloid leukemia * Acute minimally differentiated myeloid leukemia (M0) * Must be registered on protocols SWOG-9007 AND SWOG-S9910 PATIENT CHARACTERISTICS: Age * 18 to 64 Performance status * Zubrod 0-3 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No chronic liver disease * Hepatitis panel, including hepatitis B and C, negative * History of hepatitis A with positive antibody allowed Renal * Creatinine ≤ 1.5 times upper limit of normal OR * Creatinine clearance \> 60 mL/min Cardiovascular * Left ventricular function normal * Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram * No symptomatic congestive heart failure * No coronary artery disease * No cardiomyopathy * No uncontrolled arrhythmia Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior remission induction chemotherapy for ALL * Prior hydroxyurea to control WBC count allowed Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No other prior treatment for ALL
References
Publications (0)
Data not yet available