Acute Lymphoblastic Leukemia, Adult B-CellNCT04545333
The clonoSEQ® Watch Registry
An observational study of Acute Lymphoblastic Leukemia, Adult B-Cell and Chronic Lymphocytic Leukemia, run by Adaptive Biotechnologies at 14 sites in United States.
Trial summary
This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult B-Cell, Chronic Lymphocytic Leukemia, Multiple Myeloma
- What is being tested?
- clonoSEQ Assay
- How many people
- 465 participants
- Where
- 14 sitesUnited States
- Study dates
- 13 Oct 2020to 1 Oct 2023
- How long will I take part?
- 2 Years
- 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: Adult patients with a diagnosis of ALL, MM, CLL, or NHL whose SOC response assessments will include monitoring of MRD status by clonoSEQ Assay
Who may be able to join
- Patients must be able to provide written informed consent
- A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care
- Age ≥ 18 years;
- Documented hematologic malignancy (any of the below):
- MM
- ALL (B and T-cell subtypes)
Show all 9Show fewer
- B-cell NHL (all sub types)
- CLL
- Other lymphoid malignancies (upon review and approval by study chair)
Who cannot join
- Patients must not meet any of the following criteria in order to be enrolled into the study:
- Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol
- A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
American Oncology Partners of Maryland
Bethesda, Maryland, 20817
Novant Health
Charlotte, North Carolina, 28204
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Bon Secours St Francis
Greenville, South Carolina, 29607
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, 97239
University of Washington, Seattle Cancer Care Alliance
Seattle, Washington, 98102
Swedish Cancer Institute
Seattle, Washington, 98104
Edward H. Kaplan MD & Associates
Skokie, Illinois, 60076
Washington University
St Louis, Missouri, 63130
Stanford Hospital
Stanford, California, 94305
Northwest Medical Specialties
Tacoma, Washington, 98405
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). This study will enroll up to 528 patients in up to 50 sites in the United States and collect data with regard to use of the clonoSEQ MRD assay in the management of lymphoid malignancies.
Read the detailed description
Data show that detection of MRD may be important to guide treatment decisions in ALL, MM, CLL, and NHL. However, there remains a lack of real-world evidence for making therapeutic decisions based upon MRD status. This study is designed to understand when in a patient's treatment continuum the assay is used and how clonoSEQ MRD data impact the treatment decisions made by investigators.
All patients enrolled in the study will be followed for at least 2 yrs. Demographic data and disease status will be captured at study enrollment. Patients must be >/= 18 yrs of age and able to sign informed consent. A given patient is eligible to enroll in the study if the treating physician has made the decision to use the clonoSEQ assay as part of that patient's routine cancer care. Reasons for placing a clonoSEQ order and subsequent decisions made as a result of MRD data will be tracked. Patient treatment will also be tracked over the course of the study in order to understand how clonoSEQ use is incorporated into current treatment regimens.
Participating centers will include sites that actively use clonoSEQ to manage their patients with lymphoid malignancies.
- Conditions
- Acute Lymphoblastic Leukemia, Adult B-Cell, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-hodgkin Lymphoma
- Being tested
- clonoSEQ Assay
- Keywords
- Minimal residual disease, measurable residual disease, MRD, clonoSEQ, ALL, CLL, MM, NHL, Watch Registry
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Lymphoma, Non-Hodgkin, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonoSEQ AssayDiagnostic test
minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
| Study group | Role | What they receive |
|---|---|---|
| ALL | patients diagnosed with acute lymphoblastic leukemia Receives: Diagnostic Test: clonoSEQ Assay | |
| CLL | patients diagnosed with chronic lymphocytic leukemia Receives: Diagnostic Test: clonoSEQ Assay | |
| MM | patients diagnosed with multiple myeloma Receives: Diagnostic Test: clonoSEQ Assay | |
| NHL | patients diagnosed with non-Hodgkin lymphoma Receives: Diagnostic Test: clonoSEQ Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
Data will be collected to determine at what points lymphoid malignancy patients are in their treatment continuums when the clonoSEQ Assay is used to monitor MRD levels
Measured: up to 3 yrs
Secondary outcomes (2)
Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results
Data will be collected with regard to changes to treatment/drug regimens in order to determine how clonoSEQ Assay MRD results inform and impact routine clinical practice
Measured: up to 3 yrs
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
Data will be collected with regard to changes to treatment/drug regimens in order to determine how clonoSEQ Assay MRD results inform and impact routine clinical practice
Measured: up to 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start13 Oct 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Sufficient data collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, Adult B-CellStudies of the same condition, open and under way.
- 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
- 465 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heidi Simmons, PhD, Study director, Adaptive Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545333
- Sponsor's protocol ID
- ADAP-008
- Status last verified
- Jul 2024
- First submitted
- 31 Aug 2020
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
- ClinicalTrials.gov ID
- NCT04545333
- Acronym / sponsor ID
- ADAP-008
- Conditions
- Acute Lymphoblastic Leukemia, Adult B-Cell, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-hodgkin Lymphoma
- Keywords
- Minimal residual disease, measurable residual disease, MRD, clonoSEQ, ALL, CLL, MM, NHL
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient data collected.
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 Sep 2020 (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.
This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). This study will enroll up to 528 patients in up to 50 sites in the United States and collect data with regard to use of the clonoSEQ MRD assay in the management of lymphoid malignancies.
Detailed description
Data show that detection of MRD may be important to guide treatment decisions in ALL, MM, CLL, and NHL. However, there remains a lack of real-world evidence for making therapeutic decisions based upon MRD status. This study is designed to understand when in a patient's treatment continuum the assay is used and how clonoSEQ MRD data impact the treatment decisions made by investigators.
All patients enrolled in the study will be followed for at least 2 yrs. Demographic data and disease status will be captured at study enrollment. Patients must be >/= 18 yrs of age and able to sign informed consent. A given patient is eligible to enroll in the study if the treating physician has made the decision to use the clonoSEQ assay as part of that patient's routine cancer care. Reasons for placing a clonoSEQ order and subsequent decisions made as a result of MRD data will be tracked. Patient treatment will also be tracked over the course of the study in order to understand how clonoSEQ use is incorporated into current treatment regimens.
Participating centers will include sites that actively use clonoSEQ to manage their patients with lymphoid malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALL | – | Diagnostic Test: clonoSEQ Assaypatients diagnosed with acute lymphoblastic leukemia |
| CLL | – | Diagnostic Test: clonoSEQ Assaypatients diagnosed with chronic lymphocytic leukemia |
| MM | – | Diagnostic Test: clonoSEQ Assaypatients diagnosed with multiple myeloma |
| NHL | – | Diagnostic Test: clonoSEQ Assaypatients diagnosed with non-Hodgkin lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of ALL, MM, CLL, or NHL whose SOC response assessments will include monitoring of MRD status by clonoSEQ Assay
Key inclusion criteria (9 listed)
- Patients must be able to provide written informed consent
- A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care
- Age ≥ 18 years;
- Documented hematologic malignancy (any of the below):
Key exclusion criteria (3 listed)
- Patients must not meet any of the following criteria in order to be enrolled into the study:
- Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol
- A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care
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 |
|---|---|---|
| clonoSEQ Assayminimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells | Diagnostic test | ALL, CLL, MM, NHL |
Primary outcome
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings
Time frame: up to 3 yrs
Data will be collected to determine at what points lymphoid malignancy patients are in their treatment continuums when the clonoSEQ Assay is used to monitor MRD levels
2 secondary outcomes
Numbers of lymphoid malignancy patients with intensifications to their drug regimens based upon clonoSEQ MRD results
Time frame: up to 3 yrs
Numbers of lymphoid malignancy patients with de-intensifications to their drug regimens based upon clonoSEQ MRD results
Time frame: up to 3 yrs
Results and safety
The study was stopped early (reason given: Sufficient data collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Heidi Simmons, PhD study director
Adaptive Biotechnologies
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, Adult B-Cell and Chronic Lymphocytic Leukemia, run by Adaptive Biotechnologies at 14 sites 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 9 inclusion and 3 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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: Sufficient data collected.). 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?
Distribution of timepoints at which MRD is monitored using the clonoSEQ Assay in lymphoid malignancy patients in real world settings (time frame: up to 3 yrs). 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 1 Aug 2024.