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NCT01597778 · ClinicalTrials.gov registry record · Phase 3

Double Cord Versus Haploidentical (BMT CTN 1101)

A Phase 3 study, sponsored by Medical College of Wisconsin.

Completed
Registry status
Phase 3
Development phase
368
Enrollment target

NCT01597778: Completed Phase 3 study, sponsored by Medical College of Wisconsin.

NCT01597778 is a Phase 3 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 368 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01597778, a Phase 3 study, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
Phase 3
Development phase
368 participants
Enrollment target

Study Summary

Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.

Primary Outcome

The primary endpoint is PFS at 2 years post-randomization. Death or disease relapse/progression will be considered as events. The time to event is defined as the time interval from randomization to relapse/progression, to death or to last follow-up, whichever comes first. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. Minimal residual disease will not be considered evide

Interventions

  • BIOLOGICAL Haploidentical Bone Marrow Transplant
  • BIOLOGICAL Double Umbilical Cord Blood Transplant

Trial Details

FieldValue
Enrollment Target 368 participants
Start Date 2012-06
Est. Completion 2020-09-11
Phase Phase 3
Medical College of Wisconsin

447 total trials

What the finished NCT01597778 record still lists

NCT01597778 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 2 interventions - of which Haploidentical Bone Marrow Transplant is the first listed.

NCT01597778 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01597778 about?

NCT01597778 is a clinical study titled "Double Cord Versus Haploidentical (BMT CTN 1101)". Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants i...

What is the current status of trial NCT01597778?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2012-06. Estimated completion is 2020-09-11.

What interventions are being tested in trial NCT01597778?

The interventions under investigation include: Haploidentical Bone Marrow Transplant (BIOLOGICAL), Double Umbilical Cord Blood Transplant (BIOLOGICAL).

Who is sponsoring clinical trial NCT01597778?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01597778's enrollment target sits among peer trials

368 996th of 2000 higher than 1,003 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01597778, the US trial registry maintained by the National Library of Medicine. NCT01597778 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.