Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02109224
Phase
PHASE1
Status
Terminated

Conditions

  • Adult B Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Cutaneous B-Cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • HIV Infection
  • Intraocular Lymphoma
  • Multicentric Angiofollicular Lymphoid Hyperplasia
  • Nodal Marginal Zone Lymphoma
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Immunoblastic Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Refractory Plasma Cell Myeloma
  • Small Intestinal Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Testicular Lymphoma
  • Waldenstrom Macroglobulinemia

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of ibrutinib in treating B-cell non-Hodgkin lymphoma that has returned or does not respond to treatment in patients with human immunodeficiency virus (HIV) infection. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether it is safe for patients with HIV infection to receive ibrutinib while also taking anti-HIV drugs.

Key Dates

Start date
Sep 30, 2014
Status verified
Apr 2015
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Treatment (ibrutinib)
    Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to 30 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
UCLA Center for Clinical AIDS Research and EducationLos AngelesCalifornia90035-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Albert Einstein College of MedicineThe BronxNew York10461-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-2490-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)HIV
By specialty
OncologyBlood cancerInfectious disease
By research site
UCLA Center for Clinical AIDS Research and Education· Los Angeles, CAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDSiteman Cancer Center at Washington University· St Louis, MOMemorial Sloan-Kettering Cancer Center· New York, NYAlbert Einstein College of Medicine· The Bronx, NYMontefiore Medical Center - Moses Campus· The Bronx, NY

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