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Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder

NCT04337827 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-10

Study results available
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Summary

The purpose of this study is to evaluate how effective rituximab and acalabrutinib are when given as a combination treatment for newly diagnosed B cell post transplant lymphoproliferative disorder (PTLD). Currently there is no approved therapy for PTLD. Rituximab alone is commonly used and works in some cases, but not others. In addition, participants with PTLD have trouble tolerating therapies with large amounts of side effects due to their health conditions and medications for their transplant. Due to these reasons the study team is looking for a new treatment with novel targeted agents in order to improve outcomes and to minimize toxicity.

Based on emerging data of clinical efficacy of acalabrutinib in B cell malignancies and an unmet need for novel therapies in PTLD, this study will investigate the use of rituximab and acalabrutinib in participants with newly diagnosed B cell PTLD.

Conditions

  • Post-transplant Lymphoproliferative Disorder

Interventions

DRUG

Rituximab

Weekly x 4 weeks. If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto Long Term Follow Up (LTFU).

DRUG

Acalabrutinib

100mg twice per day (BID) x 4 weeks (28 day cycle) If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto LTFU.

DIAGNOSTIC_TEST

CT scans

2 weeks (day 36 ± 5 days) after end of cycle 1 treatment.

Sponsors & Collaborators

  • Deepa Jagadeesh

    lead OTHER

Principal Investigators

  • Deepa Jagadeesh, MD, MPH · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2022-06-27
Completion
2022-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04337827 on ClinicalTrials.gov