Clinical trial NCT01169363: Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy
Official title: Validation of AML Proteomic Signature Associated With Clinical Response to Ara-C Based Induction Therapy in Patients 60 Years of Age or Older Using Samples From ECOG Studies 3999, 3993 and 1490
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia in remission
recurrent adult acute myeloid 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 myelomonocytic leukemia (M4)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
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)
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E3999 and E3993 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.

Detailed description: OBJECTIVES:

Primary

* To validate a pre-specified proteomic classifier to predict the likelihood of complete response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3 acute myeloid leukemia.

Secondary

* To identify signaling nodes associated with risk of relapse among these patients who achieve a CR to induction chemotherapy.

OUTLINE: This is a multicenter study.

Previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Treated on EST-1490, E-3993, or ECOG-E3999
* Bone marrow and peripheral blood samples collected at diagnosis and before induction chemotherapy available
* No M3 disease

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Proportion of patients achieving a complete response to induction chemotherapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Our Lady of Mercy Medical Center
name: Elisabeth Paietta, PhD
role: PRINCIPAL_INVESTIGATOR
References: