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:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00454480
First received: March 27, 2007
Last updated: August 23, 2013
Last verified: August 2008
  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 [ Designated as safety issue: No ]
  • Achievement of complete remission and reasons for failure [ Designated as safety issue: No ]
  • Duration of remission, relapse rates, and deaths [ Designated as safety issue: No ]
  • Hematological and nonhematological toxicity [ Designated as safety issue: Yes ]
  • Supportive care requirements (and other aspects of health economics) [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00454480     History of Changes
Other Study ID Numbers: CDR0000526121, UHW-AML16, EU-20677, ISRCTN11036523, EUDRACT-2005-002846-14, MREC-CU106
Study First Received: March 27, 2007
Last Updated: August 23, 2013
Health Authority: Unspecified

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:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Arsenic trioxide
Daunorubicin
Fludarabine
Fludarabine phosphate
Gemtuzumab
Tipifarnib
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014