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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Eastern Cooperative Oncology Group
Study ID
NCT05289687
Phase
PHASE2
Status
Recruiting
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Conditions

  • T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab / Hyaluronidase Injection — DRUG
    Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22
  • Daratumumab / Hyaluronidase Injection — DRUG
    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.
  • Daratumumab / Hyaluronidase Injection — DRUG
    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
  • Daratumumab / Hyaluronidase Injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 25, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Course 1
    Daratumumab-hyaluronidase

Primary Outcome Measure

Complete Remission (CR) [ Time Frame: Day 29 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NorthwesternChicagoIllinois60611
Shira Dinner, MD
[email protected]
312-695-2120

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By research site
Northwestern· Chicago, IL

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