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NCT00597714 · ClinicalTrials.gov registry record · Phase 2

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant

A Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma, sponsored by David Rizzieri, MD.

Completed
Registry status
Phase 2
Development phase
264
Enrollment target
1
Study location

NCT00597714: Completed Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma, sponsored by David Rizzieri, MD.

NCT00597714 is a Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma that has completed, run by David Rizzieri, MD. The registered enrollment target is 264 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00597714, a Phase 2 study of Leukemia and Non-Hodgkin's Lymphoma, has completed, sponsored by David Rizzieri, MD.

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

Study Summary

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.

Primary Outcome

Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease rela

Interventions

  • DRUG Non-myeloablative Stem Cell Transplantation

Study Locations (1)

North Carolina

  • Duke University Health System - Durham

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2008-02
Est. Completion 2013-11
Phase Phase 2
David Rizzieri, MD

8 total trials

What the finished NCT00597714 record still lists

NCT00597714 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (46% lower).

The record links to 5 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Non-myeloablative Stem Cell Transplantation is the first listed.

NCT00597714 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT00597714 about?

NCT00597714 is a clinical study titled "Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant". The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease ...

What is the current status of trial NCT00597714?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2008-02. Estimated completion is 2013-11.

What conditions does trial NCT00597714 study?

This clinical trial studies the following conditions: Leukemia, Non-Hodgkin's Lymphoma, Myeloma, Hodgkin's Disease, Myelodysplasia.

What interventions are being tested in trial NCT00597714?

The interventions under investigation include: Non-myeloablative Stem Cell Transplantation (DRUG).

Who is sponsoring clinical trial NCT00597714?

This trial is sponsored by David Rizzieri, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00597714 being conducted?

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

Similar trials for Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00597714's enrollment target sits among peer trials

264 34th of 233 higher than 200 of 233 other Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00597714, the US trial registry maintained by the National Library of Medicine. NCT00597714 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.