To evaluate hydroxyurea and imatinib treatment for chronic myeloid leukemia

Prospective study on an effective treatment for chronic myeloid leukemia with hydroxyurea and imatinib

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54990932

Enrollment

2000

Registered

2016-01-14

Start date

2003-05-01

Completion date

Unknown

Last updated

2017-11-27

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

Conditions

Chronic myeloid leukemia (CML) Cancer Chronic myeloid leukemia

Interventions

Chronic myeloid leukemia (CML) patients who give written consent are enrolled. First stage is to control leukocytosis, which includes daily oral hydroxyurea 1-3 g for 3-7 days. A total of three treatm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Any age CML patients at different disease stages, who are responsive or non-responsive to conventional treatments are all included in this trial 2. Patients agreed to receive the treatment

Exclusion criteria

Exclusion criteria: 1. Previous history of severe cardiovascular disease (coronary arterial disease, stroke, etc.) 2. Severe chronic disease with poor prognosis (liver disease, kidney disease, etc.) 3. Illegal drug use or chronic alcoholism 4. Physical limitations, mental or intellectual disabilities 5. Any condition that may affect the development of this trial

Design outcomes

Primary

Measure	Time frame
1. Overall survival (OS): It is calculated from the start of the treatment until the last follow up or death 2. Disease-free survival (DFS): It is calculated as time of MR until the last follow-up, relapse, death from any cause, or occurrence of severe side effects. Assessed with an interval of every 6 months clinical follow up.	—

Secondary

Measure	Time frame
1. Complete hematologic remission (CHR) - Normal complete blood count and normal physical examination 2. Complete cytogenetic remission (CCR) - Normal chromosome examination with no Ph positive cells detectable on metaphase cytogenetic of bone marrow with 20-25 cells analyzed 3. Molecular remission (MR) - Negative RT-PCR evidence of the BCR-ABL mRNA All measured with clinical examination, peripheral blood test, bone marrow cell count, cytogenetic study, FISH, and QRT-PCR at an interval of 3 months 4. Quality of life (QOL) – Using “Professional Quality of Life Scale” at each 6 month clinical follow up visit	—

Measure

Time frame

1. Complete hematologic remission (CHR) - Normal complete blood count and normal physical examination 2. Complete cytogenetic remission (CCR) - Normal chromosome examination with no Ph positive cells detectable on metaphase cytogenetic of bone marrow with 20-25 cells analyzed 3. Molecular remission (MR) - Negative RT-PCR evidence of the BCR-ABL mRNA All measured with clinical examination, peripheral blood test, bone marrow cell count, cytogenetic study, FISH, and QRT-PCR at an interval of 3 months 4. Quality of life (QOL) – Using “Professional Quality of Life Scale” at each 6 month clinical follow up visit

—

Countries

China

Outcome results

None listed

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