Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT03788291
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    100 mg by mouth twice a day starting on day 8 of cycle 1
  • Rituximab — DRUG
    Administered 2 times weekly for 6 cycles. Initial dose day 1: 50 mg IV, then 50 mg SQ thereafter.

Study Details

The main purpose of this research study is to find out if the combination of acalabrutinib and high frequency low dose subcutaneous rituximab is safe and effective in patients who have previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Key Dates

Start date
Mar 25, 2019
Status verified
Sep 2024
Primary completion
May 19, 2023
Completion
May 19, 2023

Study Design

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

Arms

  • Experimental: Acalabrutinib and Rituximab treatment
    Rituximab: administered 2 times weekly for 6 cycles. Initial dose day 1: 50 mg IV, Then 50 mg SQ thereafter. Acalabrutinib: 100 mg po BID starting on day 8 of cycle 1. * Patients who have attained a complete response who are also MRD negative at cycle 12 will undergo a BM biopsy to confirm CR and MRD negatively. If confirmed, the patient will stop therapy and be followed until disease progression. * Patients not in a MRD negative CR, will continue acalabrutinib. * Repeat response assessments (CTs, MRD testing in blood) will be performed at 24 cycles of therapy for those continuing on acalabrutinib. If both negative the patient will undergo a BM biopsy to confirm CR and MRD negativity. If confirmed, the patient will stop therapy and be followed until disease progression. In the absence of a CR or if MRD +, acalabrutinib may be continued until disease progression, unacceptable toxicity or physician/patient discretion.

Primary Outcome Measure

Proportion of Subjects With a Complete Response Rate (CR) at 1 Year of Therapy [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642-

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By research site
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