Treatment of elderly patients with advanced chronic lymphocytic leukemia (CLL) with fludarabine versus chlorambucil

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36294212

Enrollment

200

Registered

2005-10-11

Start date

1999-07-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

B-Chronic Lymphocytic Leukemia (CLL) Cancer Lymphoid leukaemia

Interventions

Fludarabine 25 mg/m^2 for five days intravenously, q 28 days, maximum of six courses. Chlorambucil 0.4 mg/kg bodyweight with increasing of the dose up to 0.8 mg/kg bodyweight, q 15 days, maximum 12 mo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. B-CLL 2. Binet stage C or Binet stage B with symptoms, which require therapy, or Binet stage A with severe B-symptoms 3. Age 66 - 79 years 4. No previous treatment 5. Signed informed-consent 6. Life expectancy of more than six months 7. Eastern Cooperative Oncology Group (ECOG) status zero, one or two

Exclusion criteria

Exclusion criteria: 1. Severe organ dysfunction 2. Concomitant or previous neoplasm

Design outcomes

Primary

Measure	Time frame
Progression free survival, overall survival, duration of remission, quality of remission.	—

Secondary

Measure	Time frame
1. Toxicity 2. Quality of life	—

Countries

Germany

Outcome results

None listed

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