Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
Trial Parameters
Brief Summary
In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.
Eligibility Criteria
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 status test results confirming persistent or recurrent MRD ≥ 10-4 by flow cytometry. * Patient may have undergone a prior allogeneic stem cell transplant, but patient may not have Grafts Versus Host Disease (GVHD) that requires ongoing immunosuppressive therapy. Patient may receive prednisone if the dose is ≤ 10 mg per day. * Patient must have an ECOG performance status 0-2. * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 registration to rule out pregnancy. * Patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of