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Second chance: new combo may rescue failed stem cell transplants

NCT ID NCT02161783

Disease control Sponsor: Masonic Cancer Center, University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of chemotherapy drugs (fludarabine and cyclophosphamide) plus low-dose radiation to prepare the body for a second stem cell transplant in people whose first transplant failed. The goal is to get the new donor cells to grow and start making blood cells by day 42. The trial enrolls 50 patients with primary or secondary graft failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fludarabine, Cyclophosphamide, Total Body Irradiation, and Hematopoietic stem cell infusion
What this could lead to
If successful, this could provide a reliable rescue treatment for patients whose stem cell transplant fails, helping their new immune system take hold.
What could go wrong
This is a small, early-phase study (50 people) and the regimen carries risks like infection, graft-versus-host disease, and organ damage. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2014

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Graft failure for

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with primary or secondary graft failure, as defined below, may receive a second transplant: * Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant. * Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery. * Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood. * Recipients should have acceptable organ function defined as: * Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments. * Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal * Cardiac: left ventricular ejection fraction \> 40% Exclusion Criteria: * Uncontrolled infection at the time of transplant. * Patients with Fanconi Anemia or other DNA breakage syndromes.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary graft failure Secondary graft failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Minnesota Medical Center, Fairview

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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