A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia.

Abstract

OBJECTIVE:

Fludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety of FCR in this single-arm, multicenter study designed as a bridging study to the CLL8 study by the German CLL Study Group.

METHODS:

The study enrolled previously untreated patients with CLL of Binet stage B or C with active disease. Patients with a Cumulative Illness Rating Scale score of ≤6 and creatinine clearance of ≥70 ml/min were eligible. Patients received 6 cycles of FCR every 28 days and were followed for up to 1 year.

RESULTS:

Seven patients were enrolled. The best overall response rate according to the 1996 NCI-WG Guidelines, the primary endpoint of the study, was 71.4% (95% confidence interval, 29.0-96.3%), with one patient achieving complete response. No deaths or progression occurred during follow-up. The main adverse event was hematotoxicity. CD4-positive T-cell count decreased in all patients; most patients showed no reduction in serum immunoglobulin G.

CONCLUSION:

Although the number of patients was limited, FCR appears to be effective with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL.

CLINICAL TRIAL NUMBER:

JapicCTI-132285.

• Authors: Koji Izutsu, Tomohiro Kinoshita, Jun Takizawa, Suguru Fukuhara, Go Yamamoto, Yasuo Ohashi, Junji Suzumiya, Kensei Tobinai
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 51 Issue 3 Pg. 408-415 (Mar 03 2021) ISSN: 1465-3621 [Electronic] England
• PMID: 33244584 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Antibodies, Neoplasm
• Rituximab
• Cyclophosphamide
• Vidarabine
• fludarabine

Topics

• Aged
• Antibodies, Neoplasm (immunology)
• Antineoplastic Combined Chemotherapy Protocols (pharmacokinetics, therapeutic use)
• Area Under Curve
• Cyclophosphamide (adverse effects, pharmacokinetics, therapeutic use)
• Disease Progression
• Endpoint Determination
• Female
• Humans
• Immunosuppression Therapy
• Japan
• Leukemia, Lymphocytic, Chronic, B-Cell (blood, drug therapy, immunology)
• Male
• Middle Aged
• Remission Induction
• Rituximab (adverse effects, blood, pharmacokinetics, therapeutic use)
• Treatment Outcome
• Vidarabine (adverse effects, analogs & derivatives, pharmacokinetics, therapeutic use)