Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Kami Maddocks, MD
Study ID
NCT01479842
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia

Eligibility Criteria

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

Interventions

  • BTK inhibitor PCI-32765 — DRUG
    Given PO
  • rituximab — BIOLOGICAL
    Given IV
  • bendamustine hydrochloride — DRUG
    Given IV
  • pharmacogenomic studies — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine hydrochloride may kill more cancer cells.

Key Dates

Start date
Mar 26, 2014
Status verified
Mar 2026
Primary completion
Jul 1, 2026
Completion
Sep 1, 2026

Study Design

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

Arms

  • Experimental: Treatment (enzyme inhibitor, chemo, monoclonal antibody)
    Patients receive BTK inhibitor PCI-32765 PO QD on days 1-28. Patients also receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue receiving BTK inhibitor PCI-32765 PO in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) as determined by the incidence of dose limiting toxicities (DLT) of BTK inhibitor PCI-32765 when given in combination with rituximab and bendamustine hydrochloride [ Time Frame: during first course of therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Ohio State University Medical Center· Columbus, OH

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