Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

This study has been completed.

Study NCT00046930 Information provided by Eastern Cooperative Oncology Group

First Received on October 3, 2002. Last Updated on June 21, 2011 History of Changes

Results First Received: August 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Leukemia Myelodysplastic Syndromes
Interventions:	Biological: filgrastim Biological: sargramostim Drug: cytarabine Drug: daunorubicin hydrochloride Drug: zosuquidar trihydrochloride Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Zosuquidar	Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo	Induction treatment with daunorubicin, cytarabine and placebo

Participant Flow: Overall Study

	Zosuquidar	Placebo
STARTED	224	225
COMPLETED	212	221
NOT COMPLETED	12	4
Ineligible	12	4

Baseline Characteristics

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Reporting Groups

	Description
Zosuquidar	Induction treatment with daunorubicin, cytarabine and zosuquidar
Placebo	Induction treatment with daunorubicin, cytarabine and placebo

Baseline Measures

	Zosuquidar	Placebo	Total
Number of Participants [units: participants]	212	221	433
Age [units: years] Mean ± Standard Deviation	69.4 ± 5.5	69.2 ± 5.3	69.3 ± 5.4
Gender [units: participants]
Female	103	85	188
Male	109	136	245

Outcome Measures

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1. Primary:

Overall Survival (OS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]

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2. Secondary:

Progression-free Survival (PFS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]

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3. Secondary:

Response [ Time Frame: Assessed at the end of induction ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012

Publications of Results:

Cripe LD, Li X, Litzow M, et al.: A randomized, placebo-controlled, double blind trial of the MDR modulator, zosuquidar, during conventional induction and post-remission therapy for Pts > 60 years of age with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): ECOG 3999. [Abstract] Blood 108 (11): A-423, 2006.

Publications automatically indexed to this study:

Cripe LD, Uno H, Paietta EM, Litzow MR, Ketterling RP, Bennett JM, Rowe JM, Lazarus HM, Luger S, Tallman MS. Zosuquidar, a novel modulator of P-glycoprotein, does not improve the outcome of older patients with newly diagnosed acute myeloid leukemia: a randomized, placebo-controlled trial of the Eastern Cooperative Oncology Group 3999. Blood. 2010 Nov 18;116(20):4077-85. Epub 2010 Aug 17.

Responsible Party:	Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00046930 History of Changes
Obsolete Identifiers:	NCT00046046
Other Study ID Numbers:	CDR0000257122, E3999, U10CA021115
Study First Received:	October 3, 2002
Results First Received:	August 17, 2010
Last Updated:	June 21, 2011
Health Authority:	United States: Food and Drug Administration