Clinical trial · Interventional
Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Randomized Trial for Patients With Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over
NCT00005823CI-TRIAL-00013009completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy. PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| hydroxyurea | Drug | Hydroxyurea | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| thioguanine | Drug | Thioguanine | ALIAS |
| tretinoin | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Survival
- measure
- Response achievement
- measure
- Response duration
Secondary outcomes (3)
- measure
- Toxicity by WHO Toxicity Grading after each treatment course
- measure
- Quality of life EORTC QLQ-C30 at 3 days, 1 month, 3 months, and 6 months from study entry
- measure
- Resource use (use of blood products, antibiotics and days in hospital) after each treatment course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Acute myeloid leukemia (de novo or secondary) OR * Myelodysplastic syndrome * More than 10% myeloblasts in the bone marrow * Refractory anemia with excess blasts * Refractory anemia with excess blasts in transformation * Chronic myelomonocytic leukemia * No acute promyelocytic leukemia (FAB type M3) * No blastic phase chronic myeloid leukemia PATIENT CHARACTERISTICS: Age: * 60 and over (younger patients allowed if intensive chemotherapy not indicated) Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No liver function test ≥ 2 times normal (for non-intensive therapy arm) Renal: * Not specified Cardiovascular: * No myocardial infarction within past 6 months in patients receiving daunorubicin or PSC 833 Other: * No other concurrent active malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy for leukemia Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (7)
- BACKGROUNDSeedhouse CH, Grundy M, White P, Li Y, Fisher J, Yakunina D, Moorman AV, Hoy T, Russell N, Burnett A, Pallis M; National Cancer Research Network. Sequential influences of leukemia-specific and genetic factors on p-glycoprotein expression in blasts from 817 patients entered into the National Cancer Research Network acute myeloid leukemia 14 and 15 trials. Clin Cancer Res. 2007 Dec 1;13(23):7059-66. doi: 10.1158/1078-0432.CCR-07-1484. PMID 18056183
- BACKGROUNDBurnett AK, Milligan D, Hills RK, et al.: Does all-transretinoic acid (ATRA) have a role in non-APL acute myeloid leukaemia? Results from 1666 patients in three MRC trials. [Abstract] Blood 104 (11): A-1794, 2004.
- RESULTBurnett AK, Milligan D, Goldstone A, Prentice A, McMullin MF, Dennis M, Sellwood E, Pallis M, Russell N, Hills RK, Wheatley K; United Kingdom National Cancer Research Institute Haematological Oncology Study Group. The impact of dose escalation and resistance modulation in older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome: the results of the LRF AML14 trial. Br J Haematol. 2009 May;145(3):318-32. doi: 10.1111/j.1365-2141.2009.07604.x. Epub 2009 Mar 8. PMID 19291085
- RESULTBurnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24. doi: 10.1002/cncr.22496. PMID 17315155
- RESULTBurnett AK, Milligan DW, Prentice AG, et al.: Modification or dose or treatment duration has no impact on outcome of AML in older patients: preliminary results of the UK NCRI AML14 trial. [Abstract] Blood 106 (11): A-543, 2005.
- RESULTBurnett AK, Milligan D, Prentice AG, et al.: Low dose Ara-C versus hydroxyurea with or without retinoid in older patients not considered fit for intensive chemotherapy: the UK NCRI AML14 trial. [Abstract] Blood 104 (11): A-872, 2004.
- Pallis M, Truran L, Grundy M, et al.: P-Glycoprotein overexpresion and internal tandem duplications of FLT3 are characteristic of discrete populations of elderly AML patients. [Abstract] Blood 104 (11): A-196, 2004.