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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02765997
Recruitment Status : Withdrawn (IRB Disapproval)
First Posted : May 9, 2016
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief 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. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Myelodysplasia Biological: Unmanipulated UCB Biological: SR-1 UCB Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Active Comparator: Unmanipulated UCB
Subjects will receive unmanipulated umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
Biological: Unmanipulated UCB
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.
Other Name: Unmanipulated Umbilical Cord Blood

Experimental: StemRegenin-1 UCB
Subjects will receive StemRegenin-1 (SR-1) cultured umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
Biological: SR-1 UCB
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.
Other Name: StemRegenin-1 cultured umbilical cord blood




Primary Outcome Measures :
  1. Neutrophil Recovery [ Time Frame: Day 14 after transplantation ]
    Percentage of patients with neutrophil recovery


Secondary Outcome Measures :
  1. Secondary Graft Failure [ Time Frame: Day 100 after transplantation ]
    Percentage of patients with secondary graft failure

  2. Platelet Recovery [ Time Frame: Day 100 after transplantation ]
    Percentage of patients with platelet recovery

  3. Transplant-Related Mortality [ Time Frame: 6 months after transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765997


Locations
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United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: John Wagner, MD University of Minnesota

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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT02765997    
Other Study ID Numbers: 2016LS006
MT2016-01 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Masonic Cancer Center, University of Minnesota:
AML
ALL
MDS
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases