High-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia

Completed

• Conditions: Chronic myeloid leukemia (CML); Cancer; Myeloid leukaemia

• Registration Number: ISRCTN84226319
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Newly diagnosed patients with chronic myeloid leukemia (CML) in first chronic phase less than or equal to 6 months
2. Presence of Philadelphia chromosome or BCR/ABL rearrangement
3. Age 16 - 65 years inclusive
4. World Health Organisation (WHO) performance scale less than or equal to 2

Exclusion Criteria

1. CML in blastic phase
2. CML in accelerated phase
3. Hepatic dysfunction (bilirubin greater than or equal to 2 x normal, and/or alanine aminotransferase [ALAT] greater than 4 x normal)
4. Renal dysfunction (creatinine greater 200 mumol/l or 23 mg/dl)
5. Patients with severe cardiac, pulmonary or neurologic disease
6. Pregnant or lactating females
7. Human immunodeficiency virus (HIV) infection
8. Other malignancies, except stage I cervix carcinoma and basocellular carcinoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival

Secondary Outcome Measures

Name	Time	Method
1. Haematological and cytogenetical remission<br>2. Overall survival<br>3. Remission duration