Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Daratumumab SC, Daratumumab, DARATUMUMAB (DARZALEX®), DARATUMUMAB, Daratumumab (Subcutaneously), Daratumumab Injection, Daratumumab and Hyaluronidase-fihj
Daratumumab/ Hyaluronidase · 1 trial · 1 indication
Requires that all of the following be present. * Peripheral Blood Counts * Neutrophil count ≥ 1,000/µL. * Platelet count ≥ 100,000/µL. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Bone Marrow Aspirate and Biopsy * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines. * ≤ 5% T lymphoblasts by flow cytometry. * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
The same as for CR except with unsupported platelets \> 50,000/μL, hemoglobin \> 7 g/dL, and absolute neutrophil count \> 500/μL.
All the same response criteria in peripheral blood and bone marrow as CR with the exception that there is incomplete platelet recovery (platelets \> 75,000/uL but \< 100,000/μL independent of platelet transfusions) or incomplete neutrophil count recovery \> 750/uL but \< 1000/μL.
Bone marrow lymphoblast percent \< 0.01% (\< 10-4) by flow cytometry in a patient that fulfills count requirements for CR/CRh/CRi..
Bone Marrow Aspirate and Biopsy * Presence of \> 5% T lympho-blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.
• Relapse following MRD negativity is defined as bone marrow T lymphoblast percent ≥ 0.01% (10-4).
Failure to achieve MRD negativity as defined by bone marrow with CR/CRh/CRi with T lymphoblast percent ≥ 0.01% (10-4).
| Arm | Type | Description |
|---|---|---|
| Course 1 | EXPERIMENTAL | Daratumumab-hyaluronidase |
| Name | Type | Description |
|---|---|---|
| Daratumumab / Hyaluronidase Injection | DRUG | Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22 |
Inclusion Criteria: * Patient must have documented T cell ALL and must be in first or later hematologic CR or CRi after a minimum of 2 blocks of intensive chemotherapy. * Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10-4. * Institution must have received central MRD sta...
Daratumumab is an investigational antibody being studied for Plasma Cell Disorder, T-cell Acute Lymphoblastic Leukemia, Amyloidosis, Toxic Epidermal Necrolysis, High-risk Smoldering Multiple Myeloma, and Multiple Myeloma. It is in Phase 1 development for these oncology indications.
Daratumumab is a monoclonal antibody, classified as a -mab (antibody) targeting class. It is being studied in oncology for conditions such as Multiple Myeloma and Amyloidosis.
Daratumumab is developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. It is currently in Phase 1 clinical development.
Daratumumab is in Phase 1 clinical development. It is an investigational drug and not yet approved by the FDA. It is being studied for multiple oncology indications including Multiple Myeloma and Amyloidosis.
Daratumumab has 22 total trials, with 4 active and 18 completed. Notable trials include NCT03201965 (Phase 3, completed, in Amyloidosis), NCT03320707 (Phase 1, completed, in healthy participants), NCT04915248 (Phase 2, recruiting, in Plasmablastic Lymphoma), and NCT05250973 (Phase 2, active, in Amyloidosis).
Yes, Daratumumab is also known as Daratumumab SC, Daratumumab (DARZALEX®), Daratumumab (Subcutaneously), Daratumumab Injection, Daratumumab / Hyaluronidase Injection, Daratumumab/ Hyaluronidase, and Daratumumab and Hyaluronidase-fihj.