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NCT00963872 · ClinicalTrials.gov registry record · Phase 1

Donor Umbilical Cord Blood Transplant After Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Cancer

A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.

Terminated
Registry status
Phase 1
Development phase
31
Enrollment target

NCT00963872: Clinical Trial Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT00963872 is a Phase 1 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00963872, a Phase 1 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.

TERMINATED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I trial is studying the safety of donor umbilical cord blood transplant after fludarabine phosphate, cyclophosphamide, and total-body irradiation in treating patients with high-risk hematologic cancer (now closed). The Phase II part of this trial is studying whether priming one of two UCB units with C3a facilitates engraftment of the treated unit.

Primary Outcome

Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies.

Interventions

  • RADIATION Total body irradiation
  • DRUG cyclophosphamide
  • DRUG fludarabine phosphate
  • BIOLOGICAL Umbilical cord blood unit with C3a fragment
  • BIOLOGICAL Unmanipulated UCB Unit

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2010-03
Est. Completion 2013-08
Phase Phase 1

Why NCT00963872 stopped before completion

NCT00963872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

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

NCT00963872 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00963872 about?

NCT00963872 is a clinical study titled "Donor Umbilical Cord Blood Transplant After Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Cancer". RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cel...

What is the current status of trial NCT00963872?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-03. Estimated completion is 2013-08.

What interventions are being tested in trial NCT00963872?

The interventions under investigation include: Total body irradiation (RADIATION), cyclophosphamide (DRUG), fludarabine phosphate (DRUG), Umbilical cord blood unit with C3a fragment (BIOLOGICAL), Unmanipulated UCB Unit (BIOLOGICAL).

Who is sponsoring clinical trial NCT00963872?

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 NCT00963872's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00963872, the US trial registry maintained by the National Library of Medicine. NCT00963872 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.