Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasm, Residual

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

patients diagnosed with acute lymphoblastic leukemia

patients diagnosed with chronic lymphocytic leukemia

patients diagnosed with non-Hodgkin lymphoma

minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells

clonoSEQ Assay

Heidi Simmons, PhD

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.

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.

Remaining samples will be stored for potential use in future assay development research.

The clonoSEQ® Watch Registry

Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry

Data will be collected to determine how the clonoSEQ Assay is used as part of routine disease response assessments in lymphoid malignancy patients

Data will be collected to assess the following, as applicable, depending upon distribution of patients that enroll in this study:

* Response to treatment, duration of response, time to next therapy, duration of maintenance therapy, and survival
* Numbers of patients who proceed to transplant in the ALL and MM cohorts

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

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

Adaptive Biotechnologies

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Mantle Cell Lymphoma

Follicular Lymphoma

For DLBCL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, and potentially at relapse following CAR infusion. For DLBCL, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells

For FL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, Day+365, and potentially D+547 and at relapse following CAR infusion. For FL patients, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells

For MCL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, Day+365, and potentially D+547 and at relapse following CAR infusion. For MCL patients, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells

Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples.

ClonoSEQ

Monica Gallucci

Paul Hanson

David Miklos, MD, PhD

In this study, invesigators propose to analyze 150 DLBCL patients, 50 MCL patients, and 100 FL patients to determine the clinical utility of ctDNA- as well as circulating tumor cell (CTC)-based MRD assessment in CAR therapy patients. The project detailed in this protocol will utilize the clonoSEQ platform as specific quantification of residual DLBCL/FL/MCL and correlate its results with radiologic assessment of disease and clinical outcomes. Invesitgators predict there will be a strong correlation between ctDNA and PET/CT and dynamic changes in ctDNA will precede radiologic evidence of disease recurrence in patients following CAR therapy.

Patients will prospectively have blood samples collected prior to lymphodepleting chemotherapy and during the first 6-12 months after CAR infusion for MRD analysis. Patients will have their original tissue biopsy or bone marrow (which shows evidence of disease) analyzed to determine their clonotype for future assessments on peripheral blood sample.

Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy

Ability of ctDNA MRD assessment to predict progression-free survival (PFS) at 6 months following CAR infusion in DLBCL, FL and MCL patients.

-Determine the correlation between quantified MRD and metabolic tumor volume (MTV)

-Determine the clinical utility of MRD assessments in an exploratory analysis

-Determine the correlation between ctDNA-based and CTC-based MRD assessments in DLBCL/FL/MCL

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The clonoSEQ® Watch Registry	NCT04545333	Acute Lymphobla... Chronic Lymphoc... Multiple Myelom... Non-hodgkin Lym...	clonoSEQ Assay	18 Years -	Adaptive Biotechnologies
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy	NCT05255354	Follicular Lymp... Diffuse Large B... Mantle Cell Lym...	ClonoSEQ	18 Years -	Adaptive Biotechnologies
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy	NCT05255354	Follicular Lymp... Diffuse Large B... Mantle Cell Lym...	ClonoSEQ	18 Years -	Adaptive Biotechnologies
The clonoSEQ® Watch Registry	NCT04545333	Acute Lymphobla... Chronic Lymphoc... Multiple Myelom... Non-hodgkin Lym...	clonoSEQ Assay	18 Years -	Adaptive Biotechnologies

Spots Global Cancer Trial Database for clonoseq

Every month we try and update this database with for clonoseq cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for clonoseq

Every month we try and update this database with for clonoseq cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for clonoseq cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.