Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT04189952
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
  • Rituximab — DRUG
    Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
  • Ifosfamide — DRUG
    Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
  • Carboplatin — DRUG
    Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
  • Etoposide — DRUG
    Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.

Study Details

The purpose of this study is to test a combination treatment of acalabrutunib when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) to evaluate if it will be able to improve durable responses and cure some patients.

Key Dates

Start date
Sep 22, 2020
Status verified
May 2025
Primary completion
Jun 30, 2021
Completion
Mar 1, 2022

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib + R-ICE
    Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.

Primary Outcome Measure

Percentage of Participants Achieving Complete Response (CR) [ Time Frame: 9 weeks (End of Cycle 3) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami· Miami, FL

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