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

Summary

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.

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

DRUG

tipifarnib

GENETIC

DNA methylation analysis

GENETIC

cytogenetic analysis

GENETIC

gene expression analysis

GENETIC

mutation analysis

OTHER

diagnostic laboratory biomarker analysis

OTHER

immunologic technique

PROCEDURE

allogeneic hematopoietic stem cell transplantation

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Sponsors & Collaborators

• The University of New South Wales

  lead OTHER

Principal Investigators

• Alan K. Burnett, MD, FRCP · University Hospital of Wales

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-08-31

Primary Completion

2012-08-31

Countries

• United Kingdom

Study Locations