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NCT00683046 · ClinicalTrials.gov registry record · Phase 2

T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

A Phase 2 study, sponsored by University of Chicago.

Completed
Registry status
Phase 2
Development phase
204
Enrollment target

NCT00683046: Completed Phase 2 study, sponsored by University of Chicago.

NCT00683046 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 204 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00683046, a Phase 2 study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
204 participants
Enrollment target

Study Summary

Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Primary Outcome

All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3

Interventions

  • DRUG Fludarabine
  • DRUG Melphalan
  • DRUG Campath
  • DRUG Stem cells

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2001-11
Est. Completion 2014-12
Phase Phase 2
University of Chicago

796 total trials

What the finished NCT00683046 record still lists

NCT00683046 is an interventional study that assigns participants to a tested intervention. The registered 204 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 (53% higher).

The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.

NCT00683046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00683046 about?

NCT00683046 is a clinical study titled "T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies". Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-...

What is the current status of trial NCT00683046?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2001-11. Estimated completion is 2014-12.

What interventions are being tested in trial NCT00683046?

The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Campath (DRUG), Stem cells (DRUG).

Who is sponsoring clinical trial NCT00683046?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00683046's enrollment target sits among peer trials

204 299th of 2000 higher than 1,700 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 NCT00683046, the US trial registry maintained by the National Library of Medicine. NCT00683046 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.