Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Apr 5, 2004

Keywords

ClinConnect Summary

OBJECTIVES: I. Determine the response rate and disease free survival of HIV seronegative patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when treated with high intensity, brief duration combination chemotherapy: alternating courses of ifosfamide/cytarabine/etoposide and cyclophosphamide/doxorubicin, each with methotrexate/vincristine/dexamethasone. II. Determine the toxicity of these regimens in HIV negative patients.

OUTLINE: Patients are stratified by participating institution and disease type (diffuse small noncleaved cell lymphoma vs L3 ALL). Patie...

Gender

ALL

Eligibility criteria

• • DISEASE CHARACTERISTICS: Histologically documented diffuse small noncleaved cell lymphoma (category J by IWF) of any stage Nodal or abdominal masses with less than 25% lymphoblasts in marrow are defined as lymphoma OR Histologically documented L3 acute lymphocytic leukemia (ALL) Greater than 25% lymphoblasts in marrow is defined as ALL, regardless of presence of bulky nodal disease Lymphoma requirements include: Documentation of lymphadenopathy, splenomegaly, or hepatomegaly, presence or absence of abdominal masses, and presence or absence of B symptoms Measurable disease other than ascites and pleural effusions, bony disease, and CNS lesions Bidimensionally measurable mass on physical exam, x-ray, or CT, or MRI OR Clearly defined hepatic mass greater than 3.5 cm on CT, MRI, or ultrasound considered to represent lymphoma OR Histologically documented hepatic lymphoma with the liver extending more than 5 cm below the costal margin on quiet respiration ALL requirements include: Documentation of monoclonal surface immunoglobulin by surface immunophenotyping Lymph node biopsy strongly recommended for patients with obvious marrow involvement Disease labeled L3 but also manifested by lymphadenopathy must be evaluated as is lymphoma (see above)
• • PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Any status Life expectancy: At least 2 years Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times normal (unless further elevation is directly attributable to malignancy) Renal: Creatinine no greater than 1.5 times normal (unless further elevation is directly attributable to malignancy) Cardiovascular: No uncontrolled or severe cardiovascular disease, e.g.: No myocardial infarction within the past 6 months No congestive heart failure Other: HIV negative No active, uncontrolled bacterial, viral, or fungal infection No active, uncontrolled duodenal ulcer No other serious medical illness No serious psychiatric condition that would preclude informed consent or protocol compliance No second malignancy within 5 years except: Curatively treated carcinoma in situ of the cervix Curatively treated basal cell carcinoma Not pregnant Effective contraception required of fertile patients
• • PRIOR CONCURRENT THERAPY: Biologic: No concurrent growth factors Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified Other: No prior therapy

Trial Officials