An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Hematologic Malignancies (I-PREDICT Heme)

NCT03955276 | Terminated

• 1 other identifier: 181350
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform a prospective study that is histology-independent personalized navigation approach to cancer therapy based upon tumor molecular profile as determined by Clinical Laboratory Improvement Amendments (CLIA) certified comprehensive genomic analysis. The molecular mutation profile will then be matched to existing, FDA-approved, targeted agents or to existing clinical trials using investigational agents for treatment of patients with incurable hematologic malignancies for whom no effective standard therapy exists or who have either exhausted or are intolerant of standard options.

Conditions

Hematologic Cancer

Keywords

Hodgkin lymphoma; non-Hodgkin lymphoma; Acute leukemia; Chronic leukemia; rare hematologic tumors; Hematopoietic lymphoid/myeloid cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  Assess overall response rates to molecularly targeted matched treatment and physician's choice of unmatched standard-of-care treatment.

  3.5 years

Secondary Outcomes (4)

• Incidence of grade 3-5 adverse event

  3.5 years

• Overall response rate (ORR)

  3.5 years

• Progression free survival (PFS)

  3.5 years

• Overall survival (OS)

  3.5 years

Study Arms (2)

Matched Therapy

Targeted therapy matched to each patient's genomic/immunophenotypic tumor profile (whereby oncogenic alterations are matched with targeted agents)

Other: Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)

Unmatched Therapy

General, unmatched therapy (standard of care)

Interventions

Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician) OTHER

Biologically targeted matched treatment (chosen by treating physician)

Matched Therapy

Eligibility Criteria

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

Study Population

Patients with incurable or relapsed/refractory hematologic malignancies.

You may qualify if:

• Patients with incurable hematologic malignancies with ≥50% 2-year cancer-associated mortality.
• Patients with relapsed/refractory hematologic malignancies, irrespective of 2-year mortality, who, in the opinion of the investigator, have no treatment option expected to yield significant clinical benefit.
• Patients with a rare tumor histology (i.e., fewer than 6 cases per 100,000 per year) with no approved therapies.
• Patients must have measurable disease for malignancies: defined as at least one lesion that can be accurately measured in at least one dimension with spiral CT scan, PET-CT, MRI, or calipers by clinical exam. Or presence of hematologic abnormalities with or without bone marrow involvement.
• Patients must have evaluable tissue/blood with adequate tumor content/purity for testing as specified by the molecular profiling lab. This will be obtained during the standard of care tumor diagnosis and tumor staging evaluation.
• Age ≥ 18 years.
• ECOG Performance Status 0-2.
• New York Heart Association (NYHA) Functional Classification I-II.
• Adequate organ function that reasonably allows for safe administration of therapy.
• At the time of treatment, patients should be off other anti-tumor agents for at least 5 half-lives of the agent or 2 weeks from the last day of treatment, whichever is shorter, so long as there is recovery from clinically significant side effects from previous therapy to less than or equal Grade 1.
• Able to swallow and/or retain oral medication, if needed.
• Ability to understand and the willingness to sign a written informed consent.
• Female patients of childbearing potential must agree to use at least one form of contraception during the study.
• Patients must have at least one of the following for a diagnosis/disease status:
• Advanced symptomatic disease

You may not qualify if:

• Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response or preclude the patient from safely receiving treatment (i.e. substance abuse or psychiatric illness/social situations that would limit compliance with study requirements).
• Pregnancy, breast-feeding women or any patient with childbearing potential not using adequate pregnancy prevention.
• Inadequate end organ function that would preclude safe administration of anti-neoplastic therapy; including hepatic dysfunction (LFTs \> 5 x normal limit, total bilirubin \> 3 and Cr \> 3 x normal limit or GFR \< 20 cc/min, or symptomatic heart failure (EF \< 20%), except when organ function impairment is a consequence of underlying malignancy and there is a reasonable expectation for improvement following initiation of appropriate therapy.
• Uncontrolled infections or sepsis. Patients with chronic viral infections (including HIV, HBV/HCV) that are controlled with appropriate concurrent therapy are allowed to participate in the study, provided ongoing compliance with antiviral therapy can be reasonably expected throughout the duration of the study. Patients with acute infections must start appropriate anti-microbial therapy and demonstrate stabilization of infection prior to study initiation.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moore's Cancer Center

La Jolla, California, 92093, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A sample of the subject's blood and/or tumor specimen will be collected during screening and prior to study treatment. The sample will be reviewed by hematopathology. Genomic /immunophenotypic studies will be performed to guide therapy selection.

MeSH Terms

Conditions

Hematologic Neoplasms; Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Natalie Galanina, MD

  UCSD/MCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: May 20, 2019
• Study Start: February 7, 2019
• Primary Completion: November 20, 2020
• Study Completion: January 13, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)