RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
15 Years
N/A
Both
Lymphoma
Trial Information
RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Fernando Cabanillas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000063574
NCT ID:
NCT00002565
Start Date:
May 1994
Completion Date:
February 2007
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
