RecruitingPhase 2NCT05289687

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

A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL


Sponsor

Eastern Cooperative Oncology Group

Enrollment

20 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called daratumumab can eliminate residual leukemia cells in people with T-cell acute lymphoblastic leukemia (T-cell ALL) who are in remission but still have detectable cancer cells (called minimal residual disease, or MRD) after intensive chemotherapy. **You may be eligible if...** - You have been diagnosed with T-cell ALL - You are currently in blood cancer remission (complete or near-complete) after at least 2 cycles of intensive chemotherapy - You still have detectable cancer cells at a very small level (MRD ≥ 1 in 10,000 cells) confirmed by a central lab test - You are in reasonably good general health - If you had a prior bone marrow transplant, you do not have active graft-versus-host disease requiring immune suppression (other than low-dose prednisone) **You may NOT be eligible if...** - Your T-cell ALL is not confirmed - You are not in remission - MRD has not been confirmed by a central lab - You have active graft-versus-host disease requiring significant immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab / Hyaluronidase Injection

Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22

DRUGDaratumumab / Hyaluronidase Injection

Patients that are MRD Negative on Day 29 will receive daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57.

DRUGDaratumumab / Hyaluronidase Injection

Patients that remain MRD positive on Day 29 will receive a combination of daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57 and chemotherapy selected from the combinations listed below: * Cytarabine 3000 mg/m2, IV, Every 12 hours for 4 doses on Days 37 and 38 * Methotrexate 1000 mg/m2, IV, Over 24 hours on Day 36 OR * Methotrexate, Starting dose 100 mg/m2, IV, Days 36, 46, 56 * Vincristine, 1.5 mg/m2 (2 mg cap), IV, Days 36, 46, 56 * Pegaspargase, 2000 IU/m2 (Capped at 3750 IU), IV Days 37, 57 * Methotrexate 15 mg, IT, Days 36, 56

DRUGDaratumumab / Hyaluronidase Injection

All patients with MRD negative response after completion of previous course are eligible for daratumumab-hyaluronidase 1800mg/ 30,000 units every 2 weeks on Days 1,15, 29, 43, 57, 71, 85, and 99 for 8 doses.


Locations(1)

Northwestern

Chicago, Illinois, United States

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NCT05289687


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