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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Withdrawn
Phase 2

Conditions

Acute Lymphocytic Leukemia
Myelodysplasia
Chronic Myelogenous Leukemia
Acute Myeloid Leukemia

Treatments

Biological: SR-1 UCB
Biological: Unmanipulated UCB

Study type

Interventional

Funder types

Other

Identifiers

NCT02765997
MT2016-01 (Other Identifier)
2016LS006

Details and patient eligibility

About

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.

Sex

All

Ages

2 to 35 years old

Volunteers

No Healthy Volunteers

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.

  • 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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Unmanipulated UCB
Active Comparator group
Description:
Subjects will receive unmanipulated umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
Treatment:
Biological: Unmanipulated UCB
StemRegenin-1 UCB
Experimental group
Description:
Subjects will receive StemRegenin-1 (SR-1) cultured umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
Treatment:
Biological: SR-1 UCB

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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