Clinical trials: Daratumumab
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR…
- Trial name
- RADIA (NCT06867991)
- Testing
- Ofatumumab combined with daratumumab, Ofatumumab, Repeated intravenous immunoglobulin/plasma exchange therapy
- Where
- 2 sites in China
- Volunteers
- 200 people
- Sponsor
- The First People's Hospital of Changzhou
Sickle Cell Disease
Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody
This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell…
- Trial name
- SUN-RAY (NCT06358638)
- Testing
- Daratumumab, Alemtuzumab, Sirolimus
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Children's National Research Institute
Amyloidosis; Systemic, AL Amyloidosis
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%.
- Trial name
- NCT06192979
- Testing
- Daratumumab, Bortezomib, Dexamethasone
- Where
- 7 sites in China
- Volunteers
- 41 people
- Sponsor
- Jin Lu, MD
T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: To evaluate the safety profile of isatuximab. To evaluate the duration of response (DOR).
- Trial name
- ISLAY (NCT02999633)
- Testing
- Isatuximab SAR650984, dexamethasone, acetaminophen
- Where
- 17 sites in United States, Finland and 5 more
- Volunteers
- 14 people
- Sponsor
- Sanofi
Acute Myeloid Leukemia, Myeloid Leukemia
FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia
This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with…
- Conditions
- Acute Myeloid Leukemia, Myeloid Leukemia, Monocytic Leukemia
- Trial name
- NCT04714372
- Testing
- Daratumumab/rHuPH20, FT538, Fludarabine
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Multiple Myeloma in Relapse
Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma
The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the…
- Trial name
- SCILLA (NCT07191379)
- Testing
- The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting.
- Volunteers
- 50 people
- Sponsor
- Odense University Hospital
Plasma Cell Myeloma
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and…
- Trial name
- NCT05561387
- Testing
- Bortezomib, Daratumumab and Hyaluronidase-fihj, Dexamethasone
- Where
- 397 sites in United States
- Volunteers
- 510 people
- Sponsor
- SWOG Cancer Research Network
AL Amyloidosis
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04304144
- Testing
- CAEL-101, SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD), Daratumumab
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Aplastic Anemia, Platelet Transfusion Refractoriness
Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia
This is a phase 1, prospective, single-arm, open-label study. The aim of this study is to evaluate the transfusion responses of platelet increment by using Daratumumab among aplastic anemia patients with platelet transfusion…
- Trial name
- NCT05832216
- Testing
- Daratumumab
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Multiple Myeloma
A Study of Daratumumab
The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies…
- Trial name
- NCT05438043
- Testing
- Daratumumab, Carfilzomib, Dexamethasone
- Where
- 92 sites in United States, Belgium and 15 more
- Volunteers
- 214 people
- Sponsor
- Janssen Research & Development, LLC
T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for…
- Trial name
- ALLO-T-DART (NCT04972942)
- Testing
- Daratumumab
- Where
- 16 sites in United States
- Volunteers
- 30 people
- Sponsor
- New York Medical College
Stage II T Lymphoblastic Leukemia/Lymphoma, Stage III T Lymphoblastic Leukemia/Lymphoma
Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)
This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies.
- Conditions
- Stage II T Lymphoblastic Leukemia/Lymphoma, Stage III T Lymphoblastic Leukemia/Lymphoma, Stage IV T Lymphoblastic Leukemia/Lymphoma, T Acute Lymphoblastic Leukemia
- Trial name
- NCT07072585
- Testing
- Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration
- Volunteers
- 1,708 people
- Sponsor
- Children's Oncology Group
T-cell Acute Lymphoblastic Leukemia, Lymphoma
Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma
This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL
- Trial name
- NCT07513129
- Testing
- Venetoclax, Dexamethasone, Bortezomib
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- M.D. Anderson Cancer Center
Hemophilia A With Inhibitor
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer…
- Trial name
- NCT05888870
- Testing
- SCT800 and Daratumumab, SCT800
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab
The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.
- Trial name
- NCT04264884
- Testing
- Daratumumab
- Sponsor
- Janssen Research & Development, LLC
Nephrotic Syndrome in Children
A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.
- Trial name
- NCT07087314
- Testing
- SG301 Subcutaneous injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Mao Jianhua
Lymphoma
A Study of Isatuximab-based Therapy in Participants With Lymphoma
Primary Objectives: Phase 1 -To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma…
- Trial name
- NCT03769181
- Testing
- isatuximab SAR650984, cemiplimab REGN2810
- Where
- 20 sites in France, Italy and 5 more
- Volunteers
- 58 people
- Sponsor
- Sanofi
Immune Thrombocytopenia, Treatment
Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not…
- Trial name
- NCT07362238
- Testing
- Rituximab, Daratumumab
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Precursor Cell Lymphoblastic Leukemia-Lymphoma
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL)…
- Trial name
- NCT03384654
- Testing
- Daratumumab, Vincristine, Prednisone
- Where
- 53 sites in United States, Belgium and 8 more
- Volunteers
- 47 people
- Sponsor
- Janssen Research & Development, LLC
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic…
- Trial name
- ISAKIDS (NCT03860844)
- Testing
- Isatuximab, Dexamethasone or equivalent, Fludarabine
- Where
- 41 sites in United States, Argentina and 14 more
- Volunteers
- 67 people
- Sponsor
- Sanofi