Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEastern Cooperative Oncology Group

About this trial

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

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Daratumumab / Hyaluronidase Injection
  • Daratumumab / Hyaluronidase Injection
  • Daratumumab / Hyaluronidase Injection
  • Daratumumab / Hyaluronidase Injection

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators