Treatment of advanced, relapsed chronic lymphocytic leukemia (CLL) with fludarabine, miroxantrone and cyclophosphamide combination therapy with or without granulocyte colony stimulating factor (G-CSF)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31486124

Enrollment

165

Registered

2005-10-11

Start date

1999-08-06

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

Relapsed B-cell chronic lymphocytic leukemia (B-CLL) Cancer Lymphoid leukaemia

Interventions

Fludarabine 25 mg/m^2 day 1-3, mitoxantrone 8 mg/m^2 day 1, cyclophosphamide 200 mg/m^2 day 1-3, repeated every 28 days, maximum 6 courses. Arm A with G-CSF: 5 µg/kg bodyweight/day subcutaneously (sc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. B-cell chronic lymphocytic leukemia (B-CLL) 2. Binet stage C, Binet stage B with treatment indication 3. Maximum of 3 previous treatment regimen 4. Age 18-70 years 5. Life expectancy more than 6 months 6. Eastern Cooperative Oncology Group (ECOG) 0-3 7. Normal cardiac function 8. Signed inform consent

Exclusion criteria

Exclusion criteria: 1. Severe organ dysfunction 2. Autoimmune haemolytic anaemia (AIHA) 3. More than 3 chemotherapy regimens 4. Concomitant or previous neoplasm 5. Non-response to previous treatment with Fludarabine + Cyclophosphamide, Fludarabine + Mitoxantrone, Fludarabine + Epirubicine

Design outcomes

Primary

Measure	Time frame
1. Incidence of severe and life threatening infections 2. Incidence of severe side effects 3. Remission rate	—

Secondary

Measure	Time frame
1. Overall survival 2. Progression free survival 3. Quality of remission	—

Countries

Germany

Outcome results

None listed

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