# Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Clinical trial · The University of New South Wales

- Archive id: nct:NCT00454480
- Published: 2007-03-30
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT00454480
- Source URL: https://clinicaltrials.gov/study/NCT00454480
- Provenance: clinicaltrials

## Abstract

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells. PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- status: COMPLETED
- phase: PHASE2, PHASE3
- study type: INTERVENTIONAL
- enrollment: 2000
- sponsor: The University of New South Wales
- conditions: Leukemia; Myelodysplastic Syndromes
- interventions: BIOLOGICAL: alemtuzumab; DRUG: arsenic trioxide; DRUG: azacitidine; DRUG: busulfan; DRUG: clofarabine; DRUG: cytarabine; DRUG: daunorubicin hydrochloride; DRUG: fludarabine phosphate; DRUG: gemtuzumab ozogamicin; DRUG: melphalan
- start date: 2006-08-01
- primary completion date: 2012-08-01
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Gene & Cell Therapy](https://space-kitty.com/topics/gene-cell-therapy)

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