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RECRUITING
NCT05289687
PHASE2

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

Sponsor: Eastern Cooperative Oncology Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-05-25

Completion Date

2027-06-30

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Daratumumab / Hyaluronidase Injection

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

DRUG

Daratumumab / 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.

DRUG

Daratumumab / 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

DRUG

Daratumumab / 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