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.

Phase 2

Completed

• Conditions: Histologically aggressive non-Hodgkins lymphoma; B- or T-cell lineage with a poor prognosis (International Prognostic Factors Index score of 2 or greater).; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12605000105640
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

(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 Criteria

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified