CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
rituximab +8 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00577278
NCT00577278Phase 2Completed

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for B-Cell Non-Hodgkin Lymphoma Using Zevalin, Fludarabine and Melphalan

City of Hope Medical Center·interventional·Posted Dec 20, 2007·Updated Feb 16, 2024

In Brief

A Phase 2 clinical trial evaluating rituximab, fludarabine phosphate, and 7 other interventions for Graft Versus Host Disease and 2 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2007
Enrollment StartOct 3, 2007
Primary CompletionMay 30, 2019
Study CompletionDec 14, 2023
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 18.5 years ago

Interventions

rituximabbiological

Given IV

fludarabine phosphatedrug

Given IV

melphalandrug

Given IV

sirolimusdrug

Given PO

tacrolimusdrug

Given PO or IV

allogeneic hematopoietic stem cell transplantationprocedure

Undergo APBSCT

indium In 111 ibritumomab tiuxetanradiation

Given IV

yttrium Y 90 ibritumomab tiuxetanradiation

Given IV

laboratory biomarker analysisother

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