Status:
COMPLETED
S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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 c...
Detailed Description
OBJECTIVES: Primary * Determine the probability of 1-year continuous complete remission in patients with newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy compri...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00109837
Start Date
April 1 2005
End Date
November 1 2014
Last Update
March 25 2015
Active Locations (78)
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1
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
2
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
4
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801