Suspended

Molecular Genetic Features of Acute Leukemia

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
OtherDNA Samples
Who is being recruted

Hematologic Diseases+11

+ Hemic and Lymphatic Diseases

+ Immune System Diseases

See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: April 1999
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: August 31, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1999

Actual date on which the first participant was enrolled.

Objectives: To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome. To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome. To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features. To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.

NCT00003861
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: August 31, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

840 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, AcuteLeukemiaLeukemia, Promyelocytic, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on CALGB 8461 is strongly encouraged. Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521 or S0535 must be enrolled on CALGB 9862.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 51 locations

Naval Medical Center - San Diego

San Diego, United StatesOpen Naval Medical Center - San Diego in Google Maps

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, United States

Tunnell Cancer Center at Beebe Medical Center

Lewes, United States

CCOP - Christiana Care Health Services

Newark, United States
Suspended51 Study Centers