Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving fludarabine together with rituximab early is more effective than giving fludarabine and rituximab after observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work when given early or after observation in treating patients with previously untreated chronic lymphocytic leukemia.

Timeline

Start

2008-01

Primary completion

2016-06

Completion

2016-06

Outcome

Mixed primary results

Stopped (Enrollment): “Insufficient accrual”

registry analysis (superiority test); Arm A: High Risk Early Intervention vs Arm B: High Risk Observation + Later Treatment; p = 0.1521; Log Rank NCT00513747 ↗

registry MEDIAN Arm A: High Risk Early Intervention: 62.7 (57.3 to 66.5) months NCT00513747 ↗

registry MEDIAN Arm B: High Risk Observation + Later Treatment: 39.2 (33.9 to NA) months NCT00513747 ↗

registry analysis (superiority test); Arm A: High Risk Early Intervention vs Arm B: High Risk Observation + Later Treatment; p = 0.0097; Log Rank NCT00513747 ↗

registry analysis (superiority test); Arm A: High Risk Early Intervention vs Arm B: High Risk Observation + Later Treatment; p = 0.4645; Log Rank NCT00513747 ↗

Publications

• Deshields TL, Dueck AC, Rogers K, Brown JR, Shanafelt T, Mintzer D, Byrd JC. Perceived risk for cancer progression and psychological status in chronic lymphocytic leukemia patients: CALGB 70603 (Alliance). Leuk Lymphoma. 2019 Oct;60(10):2580-2583. doi: 10.1080/10428194.2019.1594218. Epub 2019 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fludarabine	Small molecule	—	Intravenous
Subject	Rituximab	Monoclonal antibody	—	Intravenous

Indications