Lymphoma Clinical Trial
Official title:
RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
not yet known which combination chemotherapy regimen is more effective for intermediate-grade
or immunoblastic non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic
non-Hodgkin's lymphoma.
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 standard CHOP.
III. Assess the feasibility of delivering full standard doses of chemotherapy to patients
over 60 years of age who receive granulocyte colony stimulating factor support.
IV. Compare the predictive capability of the M.D. Anderson Tumor Score System versus the
International Index System.
OUTLINE: Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO
Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DHAD
Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating
Factor (source unspecified) IDA Idarubicin, NSC-256439 IFF Ifosfamide, NSC-109724 MePRDL
Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 PRED Prednisone,
NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540
Arm I: Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL;
followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16.
Arm II: 4-Drug Combination Chemotherapy. CHOP: CTX/DOX/VCR/PRED.
PROJECTED ACCRUAL: 218 evaluable patients will be accrued over approximately 31 months to
this multicenter study. If either arm is significantly inferior at interim analyses after 31
and 60 treatment failures, consideration will be given to early closure.
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