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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002494
• Date of registration: 01/11/1999
• Primary sponsor: Cancer and Leukemia Group B
• Public title: Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
• Scientific title: HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN
• Date of first enrolment: May 1992
• Target sample size: 134
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002494
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Edward J. Lee, MD
• Affiliation: Central Maryland Oncology Center

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Leukemia

Lymphoma

Intervention(s)

Drug: cyclophosphamide

Drug: cytarabine

Drug: dexamethasone

Drug: doxorubicin hydrochloride

Drug: etoposide

Drug: ifosfamide

Drug: leucovorin calcium

Drug: mesna

Drug: methotrexate

Drug: prednisone

Drug: therapeutic hydrocortisone

Drug: vincristine sulfate

Radiation: low-LET cobalt-60 gamma ray therapy

Radiation: low-LET photon therapy

Secondary ID(s)

CDR0000077643

CLB-9251

U10CA031946

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)