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

Withdrawn before enrolling · Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplasia

In brief

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.

Key facts

Study ID

NCT02765997

Run by

Masonic Cancer Center, University of Minnesota

People needed

0

Starts

2017-04-01

Expected to finish

2022-06-01

Last updated by the study team

2017-12-05

Who can join

Age: 2 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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