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NCT00345865 · ClinicalTrials.gov registry record · Phase 2

Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
Phase 2
Development phase
473
Enrollment target

NCT00345865: Completed Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT00345865 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 473 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00345865, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
473 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells. PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Primary Outcome

Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

Interventions

  • DRUG cyclophosphamide
  • DRUG etoposide
  • DRUG carmustine
  • PROCEDURE peripheral blood stem cell transplantation
  • RADIATION irradiation therapy

Trial Details

FieldValue
Enrollment Target 473 participants
Start Date 2005-08-24
Est. Completion 2019-06-28
Phase Phase 2

What the finished NCT00345865 record still lists

NCT00345865 is an interventional study that assigns participants to a tested intervention. The registered 473 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher).

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00345865 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00345865 about?

NCT00345865 is a clinical study titled "Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma". RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some b...

What is the current status of trial NCT00345865?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 473 participants. The study started on 2005-08-24. Estimated completion is 2019-06-28.

What interventions are being tested in trial NCT00345865?

The interventions under investigation include: cyclophosphamide (DRUG), etoposide (DRUG), carmustine (DRUG), peripheral blood stem cell transplantation (PROCEDURE), irradiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00345865?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00345865's enrollment target sits among peer trials

473 78th of 2000 higher than 1,923 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00345865, the US trial registry maintained by the National Library of Medicine. NCT00345865 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.