Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), January 2009

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416598

Purpose

RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.

PURPOSE: This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: busulfan Drug: cytarabine Drug: daunorubicin hydrochloride Drug: decitabine Drug: etoposide Drug: filgrastim Procedure: autologous bone marrow transplantation Procedure: cytogenetic analysis Procedure: peripheral blood stem cell transplantation	Phase II

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Filgrastim Cytarabine Cytarabine hydrochloride Etoposide Daunorubicin hydrochloride Daunorubicin Etoposide phosphate 5-Aza-2'-deoxycytidine Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Maintenance Therapy With Decitabine (NSC #127716, IND #50733) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years.

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

Primary Outcome Measures:

Response [ Designated as safety issue: No ]
Length of response [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	November 2006
Estimated Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	15 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed acute myeloid leukemia (AML)
- More than 20% blasts in the bone marrow
- Antecedent myelodysplasia allowed provided there is no bone marrow biopsy showing myelodysplastic syndromes more than 3 months prior to study entry
- Therapy-related AML allowed provided patient has not had primary disease or received chemotherapy within the past 2 years
- No M3 disease (acute promyelocytic leukemia)
Registered on CALGB-8461 and CALGB-20602

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No prior azacitidine or decitabine
No prior treatment for leukemia or myelodysplastic syndromes, except in the following circumstances:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiation therapy for CNS leukostasis (one dose only)
- Growth factor/cytokine support
No other concurrent chemotherapy
No concurrent hormonal therapy except steroids for nausea, adrenal failure, or septic shock or hormones administered for nondisease-related conditions
No concurrent palliative radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416598

Show 42 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

William G. Blum, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

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

Study ID Numbers:	CDR0000521603, CALGB-10503
Study First Received:	December 27, 2006
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00416598
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

untreated adult acute myeloid leukemia
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
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 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)
secondary acute myeloid leukemia

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Daunorubicin
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Decitabine
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Etoposide phosphate
Leukemia, Myelomonocytic, Acute
Leukemia

Leukemia, Erythroblastic, Acute
Busulfan
Neoplasm Metastasis
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Etoposide
Acute monoblastic leukemia
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009