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NCT00516152 · ClinicalTrials.gov registry record · Phase 2

Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

A Phase 2 study of Multiple Myeloma and Non-Hodgkin's Lymphoma, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
1
Study location

NCT00516152 is a Phase 2 study of Multiple Myeloma and Non-Hodgkin's Lymphoma that has completed, run by University of California, San Francisco. The registered enrollment target is 36 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00516152, a Phase 2 study of Multiple Myeloma and Non-Hodgkin's Lymphoma, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of \< or equal to 40% at 100 days. A TRM of \> or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of \>40% at 1-year following transplant.

Interventions

  • DRUG Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF

Study Locations (1)

California

  • University of California San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2002-11
Est. Completion 2007-11
Phase Phase 2

What the Registry Record Tells You About NCT00516152

The ClinicalTrials.gov registry entry for NCT00516152 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF is the first listed.

NCT00516152 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00516152 about?

NCT00516152 is a clinical study titled "Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT". The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a t...

What is the current status of trial NCT00516152?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2002-11. Estimated completion is 2007-11.

What conditions does trial NCT00516152 study?

This clinical trial studies the following conditions: Multiple Myeloma, Non-Hodgkin's Lymphoma, Acute Myelogenous Leukemia, Chronic Myeloid Leukemia, Acute Lymphocytic Leukemia.

What interventions are being tested in trial NCT00516152?

The interventions under investigation include: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF (DRUG).

Who is sponsoring clinical trial NCT00516152?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00516152 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.