Clinical Trials /

StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies

NCT02765997

Description:

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.

Related Conditions:
  • Acute Biphenotypic Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Refractory Anemia
  • Refractory Anemia with Excess Blasts
  • Refractory Anemia with Excess Blasts-2
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies
  • Official Title: Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy

Clinical Trial IDs

  • ORG STUDY ID: 2016LS006
  • SECONDARY ID: MT2016-01
  • NCT ID: NCT02765997

Conditions

  • Acute Myeloid Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplasia

Interventions

DrugSynonymsArms
Unmanipulated UCBUnmanipulated Umbilical Cord BloodUnmanipulated UCB
SR-1 UCBStemRegenin-1 cultured umbilical cord bloodStemRegenin-1 UCB

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Unmanipulated UCBActive ComparatorSubjects will receive unmanipulated umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
    StemRegenin-1 UCBExperimentalSubjects will receive StemRegenin-1 (SR-1) cultured umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  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.
      
                     -  Acute lymphocytic leukemia (ALL) at the following stages:
      
                          -  High risk first remission.
      
                               1. Ph+ ALL, or
      
                               2. MLL rearrangement with slow early response at Day 14, or
      
                               3. Hypodiploidy (< 44 chromosomes or DNA index < 0.81), or
      
                               4. End of induction M3 bone marrow, or
      
                               5. 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
      
              Exclusion Criteria:
      
                -  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.
            
      Maximum Eligible Age:35 Years
      Minimum Eligible Age:2 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Neutrophil Recovery
      Time Frame:Day 14 after transplantation
      Safety Issue:
      Description:Percentage of patients with neutrophil recovery

      Secondary Outcome Measures

      Measure:Secondary Graft Failure
      Time Frame:Day 100 after transplantation
      Safety Issue:
      Description:Percentage of patients with secondary graft failure
      Measure:Platelet Recovery
      Time Frame:Day 100 after transplantation
      Safety Issue:
      Description:Percentage of patients with platelet recovery
      Measure:Transplant-Related Mortality
      Time Frame:6 months after transplantation
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Withdrawn
      Lead Sponsor:Masonic Cancer Center, University of Minnesota

      Trial Keywords

      • AML
      • ALL
      • MDS

      Last Updated