Acute Myeloid LeukemiaPhase 2NCT02765997
StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies
A Phase 2 study testing Unmanipulated UCB and SR-1 UCB in people with Acute Myeloid Leukemia and Acute Lymphocytic Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. Read more about this study
- Who is it for?
- Ages 2 to 35 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Unmanipulated UCB and SR-1 UCB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2017to Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 2 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose >2.5 x 107 per kilogram recipient weight. HLA matching is initially based on 4 of 6 HLA-A and B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing).
- Eligible Diseases
- Acute myelogenous leukemia (AML) at the following stages:
- Intermediate to high risk leukemia in first complete remission (CR1) based on institutional criteria.
- Any second or subsequent CR.
- Secondary AML with prior malignancy that has been in remission for at least 12 months.
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- Acute lymphocytic leukemia (ALL) at the following stages:
- High risk first remission.
- Ph+ ALL, or
- MLL rearrangement with slow early response at Day 14, or
- Hypodiploidy (< 44 chromosomes or DNA index < 0.81), or
- End of induction M3 bone marrow, or
- End of induction M2 with M2-3 at Day 42.
- High risk second CR based on institutional criteria (eg, for children, bone marrow relapse <36 months from induction or T-lineage bone marrow relapse or very early isolated central nervous system (CNS) relapse <6 months from diagnosis, or slow re-induction (stage M2-3 at day 28 after induction) regardless of length remission.
- Any third or subsequent CR.
- Biphenotypic/undifferentiated leukemia in CR
- Chronic myelogenous leukemia (CML) excluding refractory blast crisis
- Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia
- Other Inclusion Criteria
- Karnofsky score >70% (16 years and older) or a Lansky play score >70 (children <16 years) - appendix II
- Adequate organ function defined as:
- Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) >70 mL/min/1.73 m2.
- Hepatic: Bilirubin ≤2.5 x mg/dL; AST, ALT, alkaline phosphatase <5 x upper limit of normal,
- Pulmonary function: DLCO, FEV1, FEC (diffusion capacity) >50% of predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then normal O2 saturation on room air.
- Cardiac: Left ventricular ejection fraction at rest must be >45%
- Available 'back-up' HSPC graft (e.g, second partially HLA matched UCB unit, haploidentical related donor).
- Voluntary written consent signed (adult or parental) before performance of any study-related procedure not part of normal medical care
Who cannot join
- Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy.
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology.
- Active bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms).
- Prior autologous or allogeneic transplant within past 12 months.
- Other active malignancy.
- Inability to receive TBI 1320 cGy (e.g., extensive prior therapy including >12 months alkylator therapy or >6 months alkylator therapy with extensive radiation. Or prior Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy
This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplasia
- Being tested
- Unmanipulated UCB, SR-1 UCB
- Keywords
- AML, ALL, MDS
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 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.
Unmanipulated UCBBiological
Also called Unmanipulated Umbilical Cord Blood
Unmanipulated UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen [G-CSF] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement.
SR-1 UCBBiological
Also called StemRegenin-1 cultured umbilical cord blood
SR-1 UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen [G-CSF] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement.
| Study group | Role | What they receive |
|---|---|---|
| Unmanipulated UCB | Active comparator | Subjects will receive unmanipulated umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning. Receives: Biological: Unmanipulated UCB |
| StemRegenin-1 UCB | Experimental | Subjects will receive StemRegenin-1 (SR-1) cultured umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning. Receives: Biological: SR-1 UCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Recovery
Percentage of patients with neutrophil recovery
Measured: Day 14 after transplantation
Secondary outcomes (3)
Secondary Graft Failure
Percentage of patients with secondary graft failure
Measured: Day 100 after transplantation
Platelet Recovery
Percentage of patients with platelet recovery
Measured: Day 100 after transplantation
Transplant-Related Mortality
Measured: 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startApr 2017 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: IRB Disapproval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Wagner, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765997
- Sponsor's protocol ID
- 2016LS006
- Other IDs
- MT2016-01
- Status last verified
- Dec 2017
- First submitted
- 5 May 2016
- Last updated
- 5 Dec 2017
- 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 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy
- ClinicalTrials.gov ID
- NCT02765997
- Acronym / sponsor ID
- 2016LS006
- Conditions
- Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplasia
- Keywords
- AML, ALL, MDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB Disapproval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 May 2016 (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 an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unmanipulated UCB | Active comparator | Biological: Unmanipulated UCBSubjects will receive unmanipulated umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning. |
| StemRegenin-1 UCB | Experimental | Biological: SR-1 UCBSubjects will receive StemRegenin-1 (SR-1) cultured umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning. |
Who may qualify
- Ages
- 2 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (27 listed)
- Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose >2.5 x 107 per kilogram recipient weight. HLA matching is initially based on 4 of 6 HLA-A and B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing).
- Eligible Diseases
- Other Inclusion Criteria
Key exclusion criteria (6 listed)
- Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy.
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology.
- Active bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms).
- Prior autologous or allogeneic transplant within past 12 months.
- Other active 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 |
|---|---|---|
| Unmanipulated UCBAlso: Unmanipulated Umbilical Cord BloodUnmanipulated UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen [G-CSF] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement. | Biological | Unmanipulated UCB |
| SR-1 UCBAlso: StemRegenin-1 cultured umbilical cord bloodSR-1 UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen [G-CSF] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement. | Biological | StemRegenin-1 UCB |
Primary outcome
Neutrophil Recovery
Time frame: Day 14 after transplantation
Percentage of patients with neutrophil recovery
3 secondary outcomes
Secondary Graft Failure
Time frame: Day 100 after transplantation
Platelet Recovery
Time frame: Day 100 after transplantation
Transplant-Related Mortality
Time frame: 6 months after transplantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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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. This study is not recruiting at the moment.
John Wagner, MD 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?
A Phase 2 study testing Unmanipulated UCB and SR-1 UCB in people with Acute Myeloid Leukemia and Acute Lymphocytic 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 27 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Dec 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil Recovery (time frame: Day 14 after transplantation). 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 5 Dec 2017; AzTrials last refreshed its copy on 30 Oct 2026.