Main info

Identifier:

HO38 CML

Sponsor:

HOVON

Included patients:

102

Active sites:

22

(of 22)

Title:

High-dose Cytarabin versus low-dose Cytarabin plus Interferon-Alpha-2a both followed by maintenance with Interferon-Alpha-2a in Chronic Myeloid Leukemia: A Phase III study by HOVON and the Belgian CMC Study Group.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Newly diagnosed patients with CML in first phase < 6 months.
• Presence of Philadelphia chromosome or BCL/ABL rearrangement.
• Age: 16-65 years inclusive.
• WHO performance scale 0, 1, 2.
• Informed consent.

Exclusion Criteria:

• CML in blastic phase.
• CML in accelerated phase.
• CML without Ph chromosome or BCL/ABL rearrangement.
• Hepatic dysfunction.
• Renal dysfunction.
• Patients with severe cardiac, pulmonary or neurologic disease.
• Pregnant or lactating females.
• Human Immunodeficiency Virus (HIV) infection.
• Other malignancies, except stage I cervix carcinoma and basocellular carcinoma.

Participating Sites

= Active hospitals

= Inactive hospitals