Not yet recruiting
Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy
NCT07679958
Cellular Therapy, Hematologic Diseases
Vigo, Pontevedra, Spain
View Trial Details
Not yet recruiting
NCT Number: NCT04209829
Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics
Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its microenvironment.
The objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to CAR-T Cells therapy in patients with hematologic malignancies
Not yet recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
15 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patient with hematological malignancy (lymphoma, ALL, MM)
- patient integrated into a CAR-T Cells program treatment
- patient aged 15 years or over
- patient having signed a written consent; as well as his legal representative if <18 years old
Exclusion criteria
- patient with other hematological malignancies than lymphoma, LAL or MM
- patient's weight <58 kg
- patient treated with another treatment than CAR-T Cells
- patient under tutorship or curatorship
- patient not covered by a health system
Treatment and study plan
Primary outcomes
-
Complete response rate
Time frame: 90 days after (CAR)-T cell therapy initiation
Secondary outcomes
-
Overall Survival rate
Time frame: 1 year
-
Objective response rate
Time frame: 30 days
-
Objective response rate
Time frame: 90 days
-
Objective response rate
Time frame: 1 year
-
Objective response rate
Time frame: 2 years
-
Objective response rate
Time frame: 5 years
-
Objective response rate
Time frame: 10 years
-
Progression-free survival
Time frame: at 1 year
-
Incidence of adverse events
Time frame: at 30 days
-
Incidence of adverse events
Time frame: at 90 days
-
Incidence of adverse events
Time frame: at 1 year
-
Incidence of adverse events
Time frame: at 2 years
-
Incidence of adverse events
Time frame: at 5 years
-
Incidence of adverse events
Time frame: at 10 years
-
Proportion of patients with an admission in intensive care
Time frame: at 30 days
-
Proportion of patients with an admission in intensive care
Time frame: at 90 days
-
Severity of neurological toxicities
Time frame: at 30 days
Severity of neurological toxicities will be assessed by physical, and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
-
Severity of neurological toxicities
Time frame: at 90 days
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
-
Severity of neurological toxicities
Time frame: at 6 months
Severity of neurological toxicities will be assessed by physical, cognitive examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
-
Severity of neurological toxicities
Time frame: at 2 years
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
-
Severity of neurological toxicities
Time frame: at 5 years
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
-
Severity of neurological toxicities
Time frame: at 10 years
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
-
Proportion of patients with a cytokine release syndrome
Time frame: at baseline
Cytokine release syndrome will be assessed by CTCAE v5.0
-
Proportion of patients with a cytokine release syndrome
Time frame: at 7 days
Cytokine release syndrome will be assessed by CTCAE v5.0
-
Proportion of patients with a cytokine release syndrome
Time frame: at 30 days
Cytokine release syndrome will be assessed by CTCAE v5.0
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Official study title
Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
Acronym: BIOCART-HM
Important dates
- Study start
- 2019
- Primary completion
- 2025
- Study completion
- 2035
- First posted
- Dec 24, 2019
- Registry last updated
- Dec 24, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Not yet recruiting
Bispecific CD19/CD20-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells With 4-1BB and Mutated CD28 Costimulatory Domains in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies
NCT07701889
Hematologic Diseases, Hemic and Lymphatic Diseases
Buffalo, New York, United States
View Trial Details
Not yet recruiting
Clonal Hematopoiesis of Immunological Significance
NCT05969821
Autoimmune Diseases, Autoinflammatory Diseases
Paris, France
View Trial Details
Not yet recruiting
Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide for Rescuing Patients With Graft Failure
NCT05126186
Allogeneic Hematopoietic Stem Cell Transplantation, Graft Failure
View Trial Details