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

Sponsored by:	The University of New South Wales
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00454480

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: immunologic technique Other: laboratory biomarker analysis Procedure: allogeneic hematopoietic stem cell transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

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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

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

The University of New South Wales

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000526121, UHW-AML16, EU-20677, ISRCTN11036523, EUDRACT-2005-002846-14, MREC-CU106
Study First Received:	March 27, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00454480 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Leukemia, Monocytic, Acute
Anti-Infective Agents
Melphalan
Daunorubicin
Immunologic Factors
Precancerous Conditions
Acute Myelomonocytic Leukemia
Acute Monoblastic Leukemia
Leukemia, Myeloid, Acute
Refractory Anemia
Antibodies, Monoclonal
Anti-Bacterial Agents
Leukemia
Preleukemia

Acute Myelocytic Leukemia
Acute Erythroblastic Leukemia
Anemia, Refractory
Acute Myeloid Leukemia, Adult
Alemtuzumab
Azacitidine
Neoplasm Metastasis
Congenital Abnormalities
Cytarabine
Immunoglobulins
Tipifarnib
Clofarabine
Hematologic Diseases
Myelodysplastic Syndromes
Anemia

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Daunorubicin
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Antibodies, Monoclonal
Leukemia
Preleukemia
Pathologic Processes

Therapeutic Uses
Syndrome
Alemtuzumab
Azacitidine
Cytarabine
Tipifarnib
Clofarabine
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Arsenic trioxide
Enzyme Inhibitors
Leukemia, Myeloid
Fludarabine monophosphate

ClinicalTrials.gov processed this record on September 10, 2009