Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
University of Medicine and Dentistry of New Jersey
Study ID
NCT00176475
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
    Patients will receive a single day infusion of standard dose rituximab (375 mg/m2) on days -1, 6, 13, 20 approximately every 4 months (in conjunction with alternating doses of the lymphocyte infusion).
  • therapeutic allogeneic lymphocytes — BIOLOGICAL
    The product will then be assigned to the specific patient and the released product will be transported to and administered to the patient at CINJ, after premedication of the patient with acetaminophen 650 mg PO and diphenhydramine- HCl 25 mg PO. Blood product administration will be every 8 weeks and undertaken according to CINJ standard procedures

Study Details

RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease.

Key Dates

Start date
Jan 31, 2005
Status verified
Sep 2013
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008

Study Design

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

Arms

  • Experimental: Therapeutic allogeneic lymphocytes with rituximab

Primary Outcome Measure

Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08903-

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