iCare for Cancer Patients

NCT02435550 | Terminated DMC

• 2 other identifiers: IRB201500073OCR14209
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.

Conditions

Myelodysplastic Syndromes; Acute Myeloid Leukemia; Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Leukemia, Acute Lymphoblastic; Multiple Myeloma; Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Overall Response

  The overall response rate (ORR) is defined as achieving a complete remission (CR), partial remission (PR), and/or hematological improvement based on 2006 International Working Group (IWG) criteria (Cheson, et al. Blood 2006).

  Up to 5 years

Secondary Outcomes (3)

• Number of patients with drug-related Grade 3 and Grade 4 adverse events

  Up to 5 years

• Progression-free survival after treatment

  Up to five years

• Overall survival after treatment

  Up to 5 years

Study Arms (5)

Acute Myeloid Leukemia

EXPERIMENTAL

Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Genetic: Molecular diagnostic testing

Acute Lymphoblastic Leukemia

EXPERIMENTAL

Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.

Genetic: Molecular diagnostic testing

Myelodysplastic Syndrome

EXPERIMENTAL

Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Genetic: Molecular diagnostic testing

Myelofibrosis

EXPERIMENTAL

Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Genetic: Molecular diagnostic testing

Multiple Myeloma

EXPERIMENTAL

Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.

Genetic: Molecular diagnostic testing

Interventions

Molecular diagnostic testing GENETIC

Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Multiple Myeloma; Myelodysplastic Syndrome; Myelofibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals known or suspected of having a blood cancer or hematologic disorder
• Individuals with presence of extramedullary disease
• Capable of providing informed consent.

You may not qualify if:

• Does not have a blood cancer or a hematologic disorder

Sponsors & Collaborators

• University of Florida: lead
• Cellworks Group Inc.: collaborator
• Gateway for Cancer Research: collaborator

Study Sites (1)

UF Health Shands Cancer Hospital

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Multiple Myeloma; Primary Myelofibrosis

Interventions

Molecular Diagnostic Techniques

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Myeloproliferative Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques

Study Officials

• Christopher R. Cogle, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 6, 2015
• Study Start: June 26, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)