Intensive compared with nonintensive chemotherapy in treating older patients with acute myeloid leukaemia or myelodysplastic syndrome

Phase 4

Completed

• Conditions: Cancer; Myeloid leukaemia; Acute myeloid leukaemia or high-risk myelodysplastic syndrome

• Registration Number: ISRCTN62207270
• Lead Sponsor: eukaemia Research Fund (UK)

Brief Summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17315155

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-01
• Study Completion: 2003-11-01
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

Patients are eligible for AML 14 if:
1. They have one of the forms of acute myeloid leukaemia (this can be any type of the de novo or secondary AML, except acute promyelocytic leukaemia) or myelodysplastic syndrome (refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEB-t], chronic myelomonocytic leukemia [CMML]) with more than 10% myeloblasts in the bone marrow
2. They should normally be aged 60 or over, but patients under this age are eligible if the more intensive therapy employed in the current trial for younger patients with AML is not considered a suitable option
3. They have given informed consent

Exclusion Criteria

Added as of 10/12/2009:
1. Previously received cytotoxic chemotherapy for leukaemia
2. Acute promyelocytic leukaemia
3. In blast transformation of chronic myeloid leukaemia
4. Concurrent active malignancy
5. Patients with liver function test elevation greater than twice normal cannot receive Gemtuzumab Ozogamicin (Mylotarg) and are therefore not eligible for the non-intensive randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added as of 10/12/2009:<br>1. Survival<br>2. Response achievement<br>3. Response duration

Secondary Outcome Measures

Name	Time	Method
Added as of 10/12/2009:<br>1. Toxicity by WHO Toxicity Grading after each treatment course<br>2. Quality of life EORTC QLQ-C30 at 3 days, 1 month, 3 months, and 6 months from study entry<br>3. Resource use (use of blood products, antibiotics and days in hospital) after each treatment course