A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04138875
Phase
PHASE2
Status
Withdrawn

Conditions

  • Classical Hodgkin Lymphoma Type PTLD
  • Florid Follicular Hyperplasia PTLD
  • Hematopoietic/Lymphoid Cancer
  • Infectious Mononucleosis
  • Lymphoid Tumor
  • Monomorphic PTLD
  • PTLD
  • Plasmacytic Hyperplasia PTLD
  • Polymorphic PTLD

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab is dosed at 375mg/m2 as an intravenous infusion. No adjustments are necessary for hepatic or renal impairment. Dosing will be done on baseline weight and height, however in patients who experience a \>10% change in weight dosing will be readjusted.
  • Brentuximab Vedotin — DRUG
    Brentuximab vedotin is to be given as intravenous infusion at a dose of 1.2mg/kg during induction and 1.8mg/kg with each cycle. Dose reductions to 1.2mg/kg are allowed at investigator discretion.
  • Bendamustine — DRUG
    Bendamustine is to be given intravenously at a dose of 90mg/m2 on day 1 and day 2 of each high risk cycle. Dose reductions to 60mg/m2 are allowed at investigator discretion.

Study Details

This is an open label, risk-stratified, sequential treatment, phase 2 study of newly diagnosed post-transplant lymphoproliferative disorders with positive CD20 and CD30 expression. It includes an induction phase with rituximab and brentuximab vedotin (RBv), followed by a treatment phase with RBv or RBv in combination with bendamustine (RBvB) based on response to induction. The primary end point is treatment efficacy measured as the overall response rate (ORR) and progression free survival (PFS).

Key Dates

Start date
Jan 31, 2022
Status verified
Jun 2022
Primary completion
Sep 30, 2023
Completion
Dec 31, 2023

Study Design

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

Arms

  • Active Comparator: Low Risk
    Low risk patients (those in complete response (CR) after induction) will receive rituximab (375mg/m2) and brentuximab vedotin (1.8mg/m2) on day 1 of 21 day cycles, for 4 cycles.
  • Active Comparator: High Risk
    High risk patients (those who do not achieve a CR after induction), will receive rituximab (375mg/m2) and brentuximab vedotin (1.8mg/m2) on day 1 and bendamustine (90mg/m2) on day 1-2 of 21 day cycles for up to 8 cycles. Interim imaging will be performed in cycle 4 (days 14-21) and patients achieving CR will receive additional 2 cycles for a total of 6, patients achieving partial response (PR) will receive 4 additional cycles.

Primary Outcome Measure

Overall response rate (ORR) (complete + partial response rate) [ Time Frame: Up to 84 days of treatment (4 cycles of treatment) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06519-
Mayo ClinicRochesterMinnesota55902-

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