Fludarabine versus Fludarabine plus Cyclophosphamide in first line therapy of younger patients (up to 65 years) with advanced Chronic Lymphocytic Leukemia

Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75653261

Enrollment

375

Registered

2005-04-26

Start date

1999-07-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukemia (CLL), advanced stage Cancer Chronic lymphocytic leukemia

Interventions

Fludarabine 25 mg/m^2/day intravenously for five days, repeated every 28 days, maximum of six courses. Fludarabine 30 mg/m^2/day for three days intravenously plus cyclophosphamide 250

Eligibility

Inclusion criteria

Inclusion criteria: Patients with an age of up to 65 years with untreated CLL in advanced stage (all Binet stage C patients; Binet stage B with symptoms, which require therapy; Binet stage A with severe B-symptoms).

Exclusion criteria

Exclusion criteria: Patients with an age less than 18 and more than 65 years were excluded as well as patients with any previous treatment of CLL, life expectancy less than six months and an Eastern Cooperative Oncology Group performance status of more than two. Patients were also excluded if they had severe organ dysfunction, concomitant or previous other neoplasms or an autoimmune hemolytic anemia or thrombocytopenia.

Design outcomes

Primary

Measure	Time frame
Repsonse rates, quality of responses as well as progression free survival.	—

Secondary

Measure	Time frame
Survival, as well as toxicity and quality of life.	—

Countries

Austria, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026