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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454480
First Posted: March 30, 2007
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Leukemia Myelodysplastic Syndromes 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 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival
  • Achievement of complete remission and reasons for failure
  • Duration of remission, relapse rates, and deaths
  • Hematological and nonhematological toxicity
  • Supportive care requirements (and other aspects of health economics)

Estimated Enrollment: 2000
Study Start Date: August 2006
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Acute myeloid leukemia (AML) meeting the following criteria:

      • De novo or secondary AML
      • No acute promyelocytic leukemia
    • High-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
    • No blast transformation of chronic myeloid leukemia
  • Patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial MRC-AMLI5

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • AST and ALT ≤ 2 times upper limit of normal (ULN) (for patients receiving gemtuzumab ozogamicin)
  • Bilirubin ≤ 2 times ULN (for patients receiving gemtuzumab ozogamicin)
  • Creatinine normal (for patients receiving clofarabine)
  • No other concurrent active malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

  • No prior cytotoxic chemotherapy for AML

    • Hydroxyurea or similar low-dose therapy to control WBC count prior to initiation of intensive therapy allowed
  • No concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454480


  Show 96 Study Locations
Sponsors and Collaborators
The University of New South Wales
Investigators
Study Chair: Alan K. Burnett, MD, FRCP University Hospital of Wales
  More Information

ClinicalTrials.gov Identifier: NCT00454480     History of Changes
Other Study ID Numbers: CDR0000526121
UHW-AML16
EU-20677
ISRCTN11036523
EUDRACT-2005-002846-14
MREC-CU106
First Submitted: March 27, 2007
First Posted: March 30, 2007
Last Update Posted: August 26, 2013
Last Verified: August 2008

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
de novo myelodysplastic syndromes
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
previously treated myelodysplastic syndromes
refractory anemia with excess blasts
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myelomonocytic leukemia (M4)
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Fludarabine
Alemtuzumab
Clofarabine
Fludarabine phosphate
Arsenic trioxide
Tipifarnib
Gemtuzumab
Cytarabine
Melphalan
Azacitidine
Busulfan
Daunorubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents