A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT00577278
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • fludarabine phosphate — DRUG
    Given IV
  • melphalan — DRUG
    Given IV
  • sirolimus — DRUG
    Given PO
  • tacrolimus — DRUG
    Given PO or IV
  • allogeneic hematopoietic stem cell transplantation — PROCEDURE
    Undergo APBSCT
  • indium In 111 ibritumomab tiuxetan — RADIATION
    Given IV
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative Studies

Study Details

RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111 ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab, fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Oct 3, 2007
Status verified
Feb 2024
Primary completion
May 30, 2019
Completion
Dec 14, 2023

Study Design

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

Arms

  • Experimental: Treatment (chemo, monoclonal antibody therapy, transplant)
    REDUCED-INTENSITY CONDITIONING: Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. STEM CELL TRANSPLANTATION: Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.

Primary Outcome Measure

Relapse/Progression Rate at Two Years [ Time Frame: From the initial treatment to the last disease assessment, up to two years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-3000-

Find similar trials in Duarte, CA

By condition
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By specialty
OncologyBlood cancer
By research site
City of Hope Medical Center· Duarte, CA

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