CompletedPhase 2ACTRN12605000105640
A phase-II study of a modified Hyper-CVAD frontline therapy for patients with poor prognosis diffuse large B-cell and peripheral T-cell non-Hodgkins lymphoma to evaluate safety and improve remission rate.
Sponsor
Australasian Leukaemia and Lymphoma Group
Enrollment
70 participants
Start Date
Sep 7, 2001
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 15 YearssMax Age: 70 Yearss
Inclusion Criteria1
- (1)Patients with previously untreated mature (post-thymic) T-cell or NK-cell NHL and an IPI score of greater than or equal to 2 OR Patients with previously untreated diffuse large B-cell NHL (2)ECOG performance status 0 to 3 inclusive.(3)A serum creatinine of less than or equal to 0.15 mmol/L. Adequate hepatic function (bilirubin less than or equal to 2.5 x ULN), and haemopoietic indices (haemoglobin greater than or equal to 90, absolute neutrophil count greater than or equal to 1.0, platelets greater than or equal to 100), unless due to lymphomatous infiltration.(4)Seronegativity for antibodies to HIV (see 7.6)(5)Normal left ventricular ejection fraction, according to institutional criteria.(6)Written informed consent
Exclusion Criteria1
- (1)Prior diagnosis of "low-grade" NHL, although patients with discordant bone marrow histology (i.e. small cell lymphomatous infiltrate of marrow) are eligible.(2)Prior treatment for NHL.(3)Past history of serious cardiac, pulmonary, hepatic or renal disease, (4)A past history of cancer (other than non-melanoma skin cancer or carcinoma of the cervix in situ).(5)Contraindication to the use of the study drugs, including known sensitivity to E. Coli derived preparations. This includes agreement to use a medically acceptable and effective means of contraception throughout the treatment period for both male and female patients of childbearing potential.(6)Pregnant women or breast-feeding mothers. History of solid-organ transplantation.
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Interventions
A dose and time intensive chemotherapy regimen comprising alternating A and B cycles. A cycles comprise hyperfractionate cyclophosphamide, vincristine, doxorubicin and dexamethasone, and B cycles comp
A dose and time intensive chemotherapy regimen comprising alternating A and B cycles. A cycles comprise hyperfractionate cyclophosphamide, vincristine, doxorubicin and dexamethasone, and B cycles comprise high-dose methotrexate and high-dose cytosine arabinoside. A total of 6 cycles are to be delivered.
Locations(1)
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ACTRN12605000105640