Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Debiopharm International SA
Study ID
NCT02564744
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Debio 1562 — DRUG
    Administered as IV Infusion.
  • Rituximab — DRUG
    Administered as IV Infusion.

Study Details

The primary purpose of the study was to determine the safety and tolerability, anti-tumor activity of the proposed Debio 1562 dose regimens in combination with rituximab.

Key Dates

Start date
Jun 5, 2016
Status verified
May 2024
Primary completion
Jan 13, 2021
Completion
Jun 25, 2021

Study Design

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

Arms

  • Experimental: Part 1: Safety Run-in
    Participants with a diagnosis of relapsed and/or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), and with non-Hodgkin's lymphoma (NHL) including follicular lymphoma (FL), marginal zone lymphoma/mucosa-associated lymphoid tissue (MZL/MALT), mantle cell lymphoma (MCL) or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, intravenous (IV) infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
  • Experimental: Part 1: Cohort 1
    Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
  • Experimental: Part 1: Cohort 2
    Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
  • Experimental: Part 2/3: Cohort A
    Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
  • Experimental: Part 2/3: Cohort B
    Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days after end of treatment (EOT) (Up to 38 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Alabama OncologyBirminghamAlabama35211-
Carle Foundation Hospital, Cancer CenterUrbanaIllinois61801-
Abbott Northwestern Hospital, Virginia Piper Cancer InstituteMinneapolisMinnesota55407-
Novant Health OncologyWinston-SalemNorth Carolina27103-
Cleveland ClinicClevelandOhio44195-
Abramson Cancer Center of The University of PennsylvaniaPhiladelphiaPennsylvania19104-
Spartanburg Regional Healthcare SystemSpartanburgSouth Carolina29303-
Baylor University Medical CenterDallasTexas75246-
Swedish Medical CenterSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
Alabama Oncology· Birmingham, ALCarle Foundation Hospital, Cancer Center· Urbana, ILAbbott Northwestern Hospital, Virginia Piper Cancer Institute· Minneapolis, MNNovant Health Oncology· Winston-Salem, NCCleveland Clinic· Cleveland, OHAbramson Cancer Center of The University of Pennsylvania· Philadelphia, PA

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