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Acute Myeloid Leukaemia (AML) Trial 12 (modified) for patients aged under 60

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55678797
Enrollment
500
Registered
2002-08-19
Start date
1998-11-01
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

Leukaemia (acute) Cancer Leukaemia

Interventions

Four randomised comparisons: At diagnosis: 1. S-DAT versus H-DAT 2. All-trans-retinoic acid (ATRA) versus not (except for acute promyelocytic leukaemia (APL) patients who will receive ATRA) After

Sponsors

Medical Research Council (MRC) (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Have one of the forms of AML 2. Are considered suitable for intensive chemotherapy 3. Are normally under the age of 60 years, but can be older as long as intensive therapy is considered suitable 4. Have given written informed consent

Exclusion criteria

Exclusion criteria: Added as of 07/03/2007: 1. Previously received any treatment for APL 2. Other forms of AML (including CML in promyelocytic blast crisis) 3. Another concurrent active malignancy 4. Pregnant or consider the possibility of becoming pregnant during the course of treatment

Design outcomes

Primary

MeasureTime frame
Added as of 07/03/2007: Haemorrhagic complications, induction deaths, remission rate, remission duration, overall survival and the role of ATRA in correcting the coagulopathy associated with APL.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026