Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL

Part of paid clinical trials in Seattle, Washington.

Sponsor
Swedish Medical Center
Study ID
NCT03736616
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Chemotherapy
  • Ifosfamide — DRUG
    Chemotherapy
  • Etoposide — DRUG
    Chemotherapy
  • Rituximab — BIOLOGICAL
    Anti-CD20 mAb
  • Carmustine — DRUG
    Chemotherapy
  • Cytarabine — DRUG
    Chemotherapy
  • Melphalan — DRUG
    Chemotherapy
  • Autologous HSCT — OTHER
    Cellular Therapy
  • Acalabrutinib — DRUG
    Bruton's Tyrosine Kinase Inhibitor

Study Details

To evaluate the tolerability,feasibility, and efficacy of combining acalabrutinib with RICE chemotherapy as second line therapy in relapsed/refractory DLBCL patients with separate primary objectives in each of in two cohorts: Cohort A: Hematopoeitic stem cell transplantation (HSCT) eligible patients undergoing second-line salvage chemoimmunotherapy \[Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE)\] plus acalabrutinib:. Cohort B: Individuals not eligible for HSCT undergoing second-line salvage chemoimmunotherapy \[Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE)\] plus acalabrutinib followed by acalabrutinib as a maintenance therapy

Key Dates

Start date
Aug 16, 2019
Status verified
Jul 2022
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
47 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Transplant eligible
    Patients receive RICE: Rituximab 375mg/m2 IV d1, Ifosfamide 5000mg/m2, Carboplatin area under curve (AUC) 5 IV d2, Etoposide (VP16) 100mg/m2 IV d1-3 \& Acalabrutinib 100mg oral BID d1-21. Cycle is 21 days for up to 3 cycles of treatment. BEAM chemotherapy \& autoHSCT: BEAM given as Carmustine (BCNU) 300mg/m2 IV day -6 respective to stem cell infusion, VP16 200mg/m2 IV BID day -5 to day-2, Cytarabine (Ara-C) 200mg/m2 IV BID day -5 to day -2, and Melphalan 140mg/m2 IV day -1. Autologous hematopoietic stem cell infusion on day 0. Only patients with CR/PR after RICE acalabrutinib will undergo BEAM and autoHSCT Maintenance therapy: Post autoHSCT patients will receive Acalabrutinib 100mg oral BID starting on day +30 for 12 consecutive months or until progression or intolerance if occurs within those 12 months.
  • Experimental: Cohort B: Transplant ineligible
    Patients receive RICE chemoimmunotherapy + Acalabrutinib Salvage therapy: RICE: Rituximab 375mg/m2 IV d1, Ifosfamide 5000mg/m2, Carboplatin AUC 5 IV d2, Etoposide 100mg/m2 IV d1-3. Acalabrutinib 100mg oral BID d1-21. Cycle is 21 days for up to 3 cycles of treatment. Maintenance therapy: Patients will receive Acalabrutinib 100mg oral BID for 12 consecutive months or until progression or intolerance if occurs within those 12 months. Maintenance therapy will only be given to patients with stable disease or better response after 3 cycles of RICE+ acalabrutinib

Primary Outcome Measure

Cohort A: Complete Response Rate [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Swedish Cancer InstituteSeattleWashington98104
Neil Bailey
Krish Patel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Swedish Cancer Institute· Seattle, WA

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