Phase 2
N=79
S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00109837 ↗Enrolled (actual)
79
Serious AEs
2.8%
Results posted
Aug 2012
Primary outcome: Primary: Continuous Complete Remission at 1 Year — 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); 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 (Drug); radiation therapy (Radiation); allopurinol (Drug); bactrim (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Complete Remission at 1 Year |
21 | — |
| SECONDARY Toxicity |
17; 13; 3; 2; 2; 1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00109837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.