Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies

Part of paid clinical trials in Dallas, Texas.

Sponsor
Medical College of Wisconsin
Study ID
NCT05270057
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • B-cell Lymphoma
  • Burkitt Lymphoma

Eligibility Criteria

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

Interventions

  • Etoposide — DRUG
    Dose level -2=50 mg/m\^2; dose level -1=50 mg/m\^2; dose level 1=50 mg/m\^2; dose level 2=60 mg/m\^2; dose level 3=72 mg/m\^2; dose level 4=86.4 mg/m\^2; dose level 5=103.7 mg/m\^2; dose level 6=124.4 mg/m\^2; dose level 7=149.3 mg/m\^2
  • Doxorubicin — DRUG
    Dose level -2=10 mg/m\^2; dose level -1; dose level -1=10 mg/m\^2; dose level 1=10 mg/m\^2; dose level 2=12 mg/m\^2; dose level 3=14.4 mg/m\^17.3 mg/m\^2; dose level 4=17.3 mg/m\^2; dose level 5=20.7 mg/m\^2; dose level 6=24.8 mg/m\^2; dose level 7=29.8 mg/m\^2.
  • Cyclophosphamide — DRUG
    Dose level -2=480 mg/m\^2; dose -1=600 mg/m\^2; dose level 1=750 mg/m\^2; level 2=900 mg/m\^2; level 3=1080 mg/m\^2; level 4=1296 mg/m\^2; level 5=1555 mg/m\^2; level 6=1866 mg/m\^2; level 7=2239 mg/m\^2.
  • Rituximab — DRUG
    Level -2 through level 7: 375 mg/m\^2
  • Vincristine — DRUG
    Level -2 through level 7: 0.4 mg/m\^2/day
  • Prednisone — DRUG
    Level -2 through level 7: 60 mg/m\^2/twice daily (BID)
  • Loncastuximab Tesirine 0.075 mg/kg by IV — DRUG
    Cohort 1: 0.075 mg/kg by IV. The dose-expansion phase will use the maximum-tolerated dose.
  • Loncastuximab tesirine 0.12 mg/kg by IV — DRUG
    Cohort 2: 0.12 mg/kg by IV. The dose-expansion phase will use the maximum-tolerated dose.
  • Loncastuximab tesirine 0.15 mg/kg by IV — DRUG
    Cohort 3: 0.15 mg/kg by IV The dose-expansion phase will use the maximum-tolerated dose.

Study Details

The overarching hypothesis for this study is that a safe and tolerable dose (i.e., the maximum tolerated dose) will be identified for loncastuximab tesirine in combination with dose-adjusted etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), and rituximab (DA-EPOCH-R) for patients with previously untreated aggressive B-cell lymphoid malignancies.

Key Dates

Start date
Jan 26, 2023
Status verified
Oct 2025
Primary completion
May 28, 2025
Completion
Oct 11, 2027

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Loncastuximab Tesirine Dose Escalation 0.075 mg/kg by IV.
    The study uses a classic 3+3 dose-escalation design. Three patients will be enrolled into a cohort receiving 0.075 mg/kg by IV. If there is no dose-limiting toxicity (DLT) seen in any of these participants, the trial will enroll additional participants into the next higher dose cohort, which is 0.12 mg/kg by IV. If one patient experiences a DLT at a specific dose, an additional three individuals will be accrued into that same dose cohort. The third dose level is 0.15 mg/kg by IV. DLTs in two or more at a specific dose level indicates that the MTD has been exceeded; dose escalation will not be pursued, and the prior dose level will be expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD.
  • Experimental: Loncastuximab Tesirine Dose Escalation 0.12 mg/kg by IV.
    The study uses a classic 3+3 dose-escalation design. Three patients will be enrolled into a cohort receiving 0.075 mg/kg by IV. If there is no dose-limiting toxicity (DLT) seen in any of these participants, the trial will enroll additional participants into the next higher dose cohort, which is 0.12 mg/kg by IV. If one patient experiences a DLT at a specific dose, an additional three individuals will be accrued into that same dose cohort. The third dose level is 0.15 mg/kg by IV. DLTs in two or more at a specific dose level indicates that the MTD has been exceeded; dose escalation will not be pursued, and the prior dose level will be expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD.
  • Experimental: Loncastuximab Tesirine Dose Escalation 0.15 mg/kg by IV.
    The study uses a classic 3+3 dose-escalation design. Three patients will be enrolled into a cohort receiving 0.075 mg/kg by IV. If there is no dose-limiting toxicity (DLT) seen in any of these participants, the trial will enroll additional participants into the next higher dose cohort, which is 0.12 mg/kg by IV. If one patient experiences a DLT at a specific dose, an additional three individuals will be accrued into that same dose cohort. The third dose level is 0.15 mg/kg by IV. DLTs in two or more at a specific dose level indicates that the MTD has been exceeded; dose escalation will not be pursued, and the prior dose level will be expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD.
  • Experimental: Loncastuximab Tesirine Dose Escalation Maximum Tolerated Dose
    The study uses a classic 3+3 dose-escalation design. Three patients will be enrolled into a cohort receiving 0.075 mg/kg by IV. If there is no dose-limiting toxicity (DLT) seen in any of these participants, the trial will enroll additional participants into the next higher dose cohort, which is 0.12 mg/kg by IV. If one patient experiences a DLT at a specific dose, an additional three individuals will be accrued into that same dose cohort. The third dose level is 0.15 mg/kg by IV. DLTs in two or more at a specific dose level indicates that the MTD has been exceeded; dose escalation will not be pursued, and the prior dose level will be expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD. This dose will be added to this record when it is determined.
  • Experimental: Dose Expansion Phase
    Subjects will receive the recommended phase 2 dose (RP2D) identified from dose-escalation phase. This dose will be added to this record when it is determined.

Primary Outcome Measure

The maximum tolerated dose (MTD). [ Time Frame: Up to 21 days (one cycle) for each dosing cohort. ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Texas SouthwesternDallasTexas75390-
University of Wisconsin School of Medicine and Public HealthMadisonWisconsin53705-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Dallas, TX

By research site
University of Texas Southwestern· Dallas, TXUniversity of Wisconsin School of Medicine and Public Health· Madison, WIFroedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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