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NCT00580034 · ClinicalTrials.gov registry record · Phase 2

Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath

A Phase 2 study of Lymphoma and Leukemia, sponsored by David Rizzieri, MD.

Completed
Registry status
Phase 2
Development phase
176
Enrollment target
1
Study location

NCT00580034: Completed Phase 2 study of Lymphoma and Leukemia, sponsored by David Rizzieri, MD.

NCT00580034 is a Phase 2 study of Lymphoma and Leukemia that has completed, run by David Rizzieri, MD. The registered enrollment target is 176 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (64% 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

NCT00580034, a Phase 2 study of Lymphoma and Leukemia, has completed, sponsored by David Rizzieri, MD.

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

Study Summary

Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though the potential toxicities of the procedure remain high. We and others have shown that a less toxic preparative regimen allows reliable allogeneic engraftment for allogeneic transplantation. The primary purpose of this treatment trial is to follow patients undergoing allogeneic transplantation for long term outcomes. The regimen used has been tested in our prior phase I / II trial which has completed accrual. The issues of engraftment and rate of graft versus host disease have been answered and our success has led to this regimen being a standard approach for less toxic allogeneic therapy.

Primary Outcome

Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 day

Interventions

  • DRUG Campath Purged Non-myeloablative ASCT
  • PROCEDURE Donor Apheresis

Study Locations (1)

North Carolina

  • Duke University Health Systems - Durham

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2003-02
Est. Completion 2013-04
Phase Phase 2
David Rizzieri, MD

8 total trials

What the finished NCT00580034 record still lists

NCT00580034 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (64% lower).

The record links to 5 conditions, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Campath Purged Non-myeloablative ASCT is the first listed.

NCT00580034 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT00580034 about?

NCT00580034 is a clinical study titled "Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath". Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though the potential toxicities of the procedure remain high. We and others have shown that a less toxic preparative regimen allows reliable allogeneic engraftment for allogeneic transplantation. The primary purp...

What is the current status of trial NCT00580034?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2003-02. Estimated completion is 2013-04.

What conditions does trial NCT00580034 study?

This clinical trial studies the following conditions: Lymphoma, Leukemia, Solid Tumors, Myeloma, Myelodysplasia.

What interventions are being tested in trial NCT00580034?

The interventions under investigation include: Campath Purged Non-myeloablative ASCT (DRUG), Donor Apheresis (PROCEDURE).

Who is sponsoring clinical trial NCT00580034?

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

Where is trial NCT00580034 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 Lymphoma

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 NCT00580034's enrollment target sits among peer trials

176 54th of 299 higher than 246 of 299 other Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lymphoma 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 NCT00580034, the US trial registry maintained by the National Library of Medicine. NCT00580034 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.