Acute LeukemiaPhase 2NCT03314974
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
A Phase 2 study testing HSCT with TBI Regimen and HSCT with Non-TBI Regimen in people with Acute Leukemia and Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- HSCT with TBI Regimen and HSCT with Non-TBI Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2018to 10 Jun 2028
- Phase
- Phase 2
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
- CML in blast crisis
- Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
- Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
- Active central nervous system malignancy
- if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
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- Active HIV infection or known HIV positive serology
- active uncontrolled infection
- Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
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
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55337
Tamy Grainger, RN, 612-273-2800, tgraing1@fairview.org
About this study
Official title: Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases
This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).
- Conditions
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia
- Being tested
- HSCT with TBI Regimen, HSCT with Non-TBI Regimen
- Keywords
- AML, ALL, MDS, NHL, CLL, CML, SLL
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Plasma Cell, Myeloproliferative Disorders, Primary Myelofibrosis, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSCT with TBI RegimenBiological
Also called Hematopoietic Stem Cell Transplantation
Day -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD
HSCT with Non-TBI RegimenBiological
Also called Hematopoietic Stem Cell Transplantation
Day -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD
| Study group | Role | What they receive |
|---|---|---|
| TBI Regimen | Experimental | Not described Receives: Biological: HSCT with TBI Regimen |
| Non-TBI Regimen | Experimental | Not described Receives: Biological: HSCT with Non-TBI Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic GVHD - 1 year
Incidence of chronic GVHD
Measured: 1 year
Secondary outcomes (11)
Grade II-IV acute GVHD
Cumulative incidence grade II-IV acute GVHD
Measured: Day +100
Chronic GVHD - 2 years
Incidence of chronic GVHD
Measured: 2 years
Relapse
Cumulative incidence of relapse
Measured: 2 years
Overall survival
Cumulative incidence of overall survival
Measured: 2 years
Treatment-related mortality
Cumulative incidence of treatment-related mortality
Measured: 2 years
Graft-versus-host disease-free, relapse free survival (GRFS)
Cumulative incidence of GRFS
Measured: 1 year
Graft-versus-host disease-free, relapse free survival (GRFS)
Cumulative incidence of GRFS
Measured: 2 years
Neutrophil Engraftment
Cumulative incidence of Neutrophil Engraftment
Measured: Day 42
Neutrophil Engraftment
Cumulative incidence of Neutrophil Engraftment
Measured: 6 months
Platelet Engraftment
Cumulative incidence of Platelet Engraftment
Measured: Day 42
Platelet Engraftment
Cumulative incidence of Platelet Engraftment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start30 Mar 2018
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Punita Grover, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314974
- Sponsor's protocol ID
- 2015LS034
- Other IDs
- MT2015-29
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2017
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases
- ClinicalTrials.gov ID
- NCT03314974
- Acronym / sponsor ID
- 2015LS034
- Conditions
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia
- Keywords
- AML, ALL, MDS, NHL, CLL, CML, SLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2028 (estimated)
- First posted
- 19 Oct 2017 (actual)
- 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 Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Regimen | Experimental | Biological: HSCT with TBI Regimen |
| Non-TBI Regimen | Experimental | Biological: HSCT with Non-TBI Regimen |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
- CML in blast crisis
- Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
- Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
- Active central nervous system malignancy
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 |
|---|---|---|
| HSCT with TBI RegimenAlso: Hematopoietic Stem Cell TransplantationDay -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD | Biological | TBI Regimen |
| HSCT with Non-TBI RegimenAlso: Hematopoietic Stem Cell TransplantationDay -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD | Biological | Non-TBI Regimen |
Primary outcome
Chronic GVHD - 1 year
Time frame: 1 year
Incidence of chronic GVHD
11 secondary outcomes
Grade II-IV acute GVHD
Time frame: Day +100
Chronic GVHD - 2 years
Time frame: 2 years
Relapse
Time frame: 2 years
Overall survival
Time frame: 2 years
Treatment-related mortality
Time frame: 2 years
Graft-versus-host disease-free, relapse free survival (GRFS)
Time frame: 1 year
Graft-versus-host disease-free, relapse free survival (GRFS)
Time frame: 2 years
Neutrophil Engraftment
Time frame: Day 42
Neutrophil Engraftment
Time frame: 6 months
Platelet Engraftment
Time frame: Day 42
Platelet Engraftment
Time frame: 6 months
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 25 Jun 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.
Punita Grover, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSCT with TBI Regimen and HSCT with Non-TBI Regimen in people with Acute Leukemia and Acute Myeloid Leukemia, 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 0 inclusion and 9 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 25 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tamy Grainger ((612)-273-2800, tgraing1@fairview.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic GVHD - 1 year (time frame: 1 year). 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 25 Jun 2026.