Hematologic CancerI-PREDICT HemeNCT03955276
An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Hematologic Malignancies (I-PREDICT Heme)
An observational study of Hematologic Cancer, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer
- What is being tested?
- Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 13 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with incurable or relapsed/refractory hematologic malignancies.
Who may be able to join
- 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.
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- 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
- Medically unfit for standard therapy
- Disease where no conventional therapy leads to a survival benefit > 3 months in the respective cohort and line of therapy for which the patient is otherwise eligible
- Actionable biologically informed targets determined by certified genomic profiling, immunophenotyping or other clinically validated techniques.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moore's Cancer Center
La Jolla, California, 92093
About this study
Official title: An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Hematologic Malignancies and Poor Prognoses (I-PREDICT Heme)
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
- Being tested
- Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)
- Keywords
- Hodgkin lymphoma, non-Hodgkin lymphoma, Acute leukemia, Chronic leukemia, rare hematologic tumors, Hematopoietic lymphoid/myeloid cancer
- Medical subject headings
- Hematologic Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)Other
Biologically targeted matched treatment (chosen by treating physician)
| Study group | Role | What they receive |
|---|---|---|
| Matched Therapy | Targeted therapy matched to each patient's genomic/immunophenotypic tumor profile (whereby oncogenic alterations are matched with targeted agents) Receives: Other: Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician) | |
| Unmatched Therapy | General, unmatched therapy (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Assess overall response rates to molecularly targeted matched treatment and physician's choice of unmatched standard-of-care treatment.
Measured: 3.5 years
Secondary outcomes (4)
Incidence of grade 3-5 adverse event
Incidence of grade 3-5 adverse events in all groups according to CTCAE v4.03
Measured: 3.5 years
Overall response rate (ORR)
Overall response rate (ORR) defined as partial response (PR) or complete response (CR) according to disease specific NCCN response criteria
Measured: 3.5 years
Progression free survival (PFS)
Progression free survival (PFS) defined as time from first dose to disease progression or death whichever occurs first
Measured: 3.5 years
Overall survival (OS)
Overall survival (OS) defined as time from first dose to death due to any cause
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start7 Feb 2019
- Primary completion20 Nov 2020
- Study completion13 Jan 2021
Why it stopped: PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Galanina, MD, Principal investigator, UCSD/MCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955276
- Sponsor's protocol ID
- 181350
- Acronym
- I-PREDICT Heme
- Status last verified
- Jan 2022
- First submitted
- 1 Apr 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Hematologic Malignancies and Poor Prognoses (I-PREDICT Heme)
- ClinicalTrials.gov ID
- NCT03955276
- Acronym / sponsor ID
- I-PREDICT Heme / 181350
- Conditions
- Hematologic Cancer
- Keywords
- Hodgkin lymphoma, non-Hodgkin lymphoma, Acute leukemia, Chronic leukemia, rare hematologic tumors, Hematopoietic lymphoid/myeloid cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched Therapy | – | Other: Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)Targeted therapy matched to each patient's genomic/immunophenotypic tumor profile (whereby oncogenic alterations are matched with targeted agents) |
| Unmatched Therapy | – | –General, unmatched therapy (standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with incurable or relapsed/refractory hematologic malignancies.
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)Biologically targeted matched treatment (chosen by treating physician) | Other | Matched Therapy |
Primary outcome
Response rate
Time frame: 3.5 years
Assess overall response rates to molecularly targeted matched treatment and physician's choice of unmatched standard-of-care treatment.
4 secondary outcomes
Incidence of grade 3-5 adverse event
Time frame: 3.5 years
Overall response rate (ORR)
Time frame: 3.5 years
Progression free survival (PFS)
Time frame: 3.5 years
Overall survival (OS)
Time frame: 3.5 years
Results and safety
The study was stopped early (reason given: PI left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Galanina, MD principal investigator
UCSD/MCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.