Search / Trial NCT00002565

Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma

Launched by M.D. ANDERSON CANCER CENTER · Jun 29, 2004

Trial Information

Current as of December 27, 2024

Completed

Keywords

Stage I Grade 3 Follicular Lymphoma Stage I Adult Diffuse Mixed Cell Lymphoma Stage I Adult Diffuse Large Cell Lymphoma Stage I Adult Immunoblastic Large Cell Lymphoma Stage Ii Grade 3 Follicular Lymphoma Stage Ii Adult Diffuse Mixed Cell Lymphoma Stage Ii Adult Diffuse Large Cell Lymphoma Stage Ii Adult Immunoblastic Large Cell Lymphoma Stage Iii Grade 3 Follicular Lymphoma Stage Iii Adult Diffuse Mixed Cell Lymphoma Stage Iii Adult Diffuse Large Cell Lymphoma Stage Iii Adult Immunoblastic Large Cell Lymphoma Stage Iv Grade 3 Follicular Lymphoma Stage Iv Adult Diffuse Mixed Cell Lymphoma Stage Iv Adult Diffuse Large Cell Lymphoma Stage Iv Adult Immunoblastic Large Cell Lymphoma Contiguous Stage Ii Grade 3 Follicular Lymphoma Contiguous Stage Ii Adult Diffuse Mixed Cell Lymphoma Contiguous Stage Ii Adult Immunoblastic Large Cell Lymphoma Contiguous Stage Ii Adult Diffuse Large Cell Lymphoma Noncontiguous Stage Ii Grade 3 Follicular Lymphoma Noncontiguous Stage Ii Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage Ii Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage Ii Adult Diffuse Large Cell Lymphoma

ClinConnect Summary

OBJECTIVES:

I. Compare, in a randomized setting, the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) versus the new alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide).

II. Compare the complete response rate achieved with ATT versus standa...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Previously untreated non-Hodgkin's lymphoma (NHL) of one of the following histologies: Diffuse large cell Follicular large non-cleaved cell Diffuse mixed cell Immunoblastic At least 2 of the following poor-prognosis factors required: Age over 60 Performance status greater than 1 Any elevation of LDH More than 1 extranodal site Ann Arbor stage III or IV T- and B-cell NHL eligible if meeting all above criteria No primary CNS lymphoma Brain involvement eligible if not primary
  • PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Any status Hematopoietic: (unless secondary to tumor) Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Elevation secondary to tumor discussed with study chairman Renal: (unless secondary to tumor) Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 55% by echocardiography Pulmonary: No chronic obstructive or restrictive lung disease Pulmonary consultation required in cases of doubt Other: No HIV infection No prior malignancy with less than a 90% 5-year survival probability No patients unable or unlikely to adhere to treatment because of geographic, economic, emotional, or social factors No unwillingness to accept blood product transfusions or other supportive measures (e.g., antibiotics)
  • PRIOR CONCURRENT THERAPY: No prior therapy

Trial Officials

Fernando Cabanillas, MD

Study Chair

M.D. Anderson Cancer Center

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Sao Paulo, , Brazil

Santiago, , Chile

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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