Primary Graft FailureNCT02161783
Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
An observational study of Primary Graft Failure and Secondary Graft Failure, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Graft Failure, Secondary Graft Failure
- What is being tested?
- Fludarabine, Cyclophosphamide and Total Body Irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2014to 30 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Graft failure for
Who may be able to join
- 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%
Who cannot join
- Uncontrolled infection at the time of transplant.
- Patients with Fanconi Anemia or other DNA breakage syndromes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
Timothy Krepski, 612-273-2800, tkrepsk1@fairview.org
Troy C Lund, MD, PhD
About this study
This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.
The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.
- Conditions
- Primary Graft Failure, Secondary Graft Failure
- Being tested
- Fludarabine, Cyclophosphamide, Total Body Irradiation, Hematopoietic stem cell infusion
- Keywords
- Hematopoietic stem cell transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludara
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
CyclophosphamideDrug
Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant.
Total Body IrradiationRadiation
Also called TBI
TBI 200cGy in a single fraction on day -1 from transplant.
Hematopoietic stem cell infusionBiological
Also called HSCT
Hematopoietic stem cell infusion given on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Radiation: Total Body Irradiation; Biological: Hematopoietic stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of donor engraftment
Rate of sustained donor engraftment at day 42 post this transplant.
Measured: day 42
Secondary outcomes (5)
Rate of treatment related mortality
Rate of treatment related mortality (TRM) at day 100
Measured: day 100
Rate of survival
Rate of survival by day 100.
Measured: Day 100
Rate of survival
Rate of survival at 1 year
Measured: 1 year
Incidence of acute graft-versus-host disease
Incidence of acute graft-versus-host disease by day 100
Measured: Day 100
Incidence of chronic graft-versus-host disease
Incidence of chronic graft-versus-host disease at 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study start6 Oct 2014
- Primary completion24 Jan 2032 (estimated)
- Study completion30 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Graft FailureStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troy C Lund, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161783
- Sponsor's protocol ID
- 2013OC003
- Other IDs
- MT2013-06C
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2014
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02161783
- Acronym / sponsor ID
- 2013OC003
- Conditions
- Primary Graft Failure, Secondary Graft Failure
- Keywords
- Hematopoietic stem cell transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- 24 Jan 2032 (estimated)
- Study completion
- 30 Jan 2032 (estimated)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.
The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Biological: Hematopoietic stem cell infusionThis regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Graft failure for
Key inclusion criteria (8 listed)
- Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
- Recipients should have acceptable organ function defined as:
Key exclusion criteria (2 listed)
- Uncontrolled infection at the time of transplant.
- Patients with Fanconi Anemia or other DNA breakage syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineAlso: FludaraFludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant. | Drug | Treatment |
| CyclophosphamideCyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant. | Drug | Treatment |
| Total Body IrradiationAlso: TBITBI 200cGy in a single fraction on day -1 from transplant. | Radiation | Treatment |
| Hematopoietic stem cell infusionAlso: HSCTHematopoietic stem cell infusion given on day 0. | Biological | Treatment |
Primary outcome
Rate of donor engraftment
Time frame: day 42
Rate of sustained donor engraftment at day 42 post this transplant.
5 secondary outcomes
Rate of treatment related mortality
Time frame: day 100
Rate of survival
Time frame: Day 100
Rate of survival
Time frame: 1 year
Incidence of acute graft-versus-host disease
Time frame: Day 100
Incidence of chronic graft-versus-host disease
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Troy C Lund, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Graft Failure and Secondary Graft Failure, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Krepski (612-273-2800, tkrepsk1@fairview.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of donor engraftment (time frame: day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.