Prognostic factors and early risk-adapted therapy in patients with chronic lymphocytic leukemia in Binet stage A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31378214

Enrollment

320

Registered

2005-10-06

Start date

1997-07-01

Completion date

Unknown

Last updated

2020-03-03

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

Conditions

Chronic Lymphocytic Leukemia (CLL) Binet stage A, untreated Cancer Lymphoid leukaemia

Interventions

1. Intervention: randomised treatment with fludarabine (25 mg/m^2, days one to five, every 28 days, for a maximum of six courses) in high risk patients 2. Control: Watch and wait

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) in Binet stage A 2. Initial diagnosis within the last three years 3. No previous therapy 4. Age between 18 and 75 years 5. Eastern Cooperative Oncology Group (ECOG) status zero to two 6. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Autoimmune cytopenia 2. Severe concommitant disease 3. Concomitant secondary neoplasia 4. Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
1. Overall survival 2. Quality of life 3. Incidence of infections	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026