Safety Study of MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia

Completed · Phase 1

Conditions studied: Hematologic Malignancies

In brief

The purpose of this study is to determine if MultiStem® can safely be given to patients with acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received hematopoietic stem cell transplantation.

Key facts

Study ID

NCT00677859

Run by

Healios K.K.

People needed

36

Starts

2008-07-01

Expected to finish

2011-11-01

Last updated by the study team

2012-01-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of either sex aged 18-65 years of age
• Diagnosis of acute myeloid or lymphoblastic leukemia (second or subsequent remission, if not in remission, then <20% bone marrow blasts), chronic myelogenous leukemia resistant to or intolerant of tyrosine kinase inhibitor therapy (accelerated phase, first chronic phase with TKI resistance, or second chronic phase), or myelodysplastic syndrome (intermediate/high or high risk by International Prognostic Scoring System (IPSS), lower risk by IPSS with patient having progressed after prior therapy. Complete remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment and <5% blasts in the marrow within 28 days of enrollment.
• Life expectancy of at least 100 days
• Patients scheduled for allogeneic bone marrow transplant or peripheral blood stem cell transplant (PBST) procedure
• Family-related or unrelated donors
• HLA matching should either be matched related or matched unrelated donors, 6/6 match or 5/6 single allelic mismatch, with provision that the DRB1 is molecularly matched
• Performance status (ECOG ≤2)
• Signed informed consent

You may not qualify if…

• Active infection
• Known allergies to bovine or porcine products
• Renal function: Serum creatinine >2 mg/dL or creatinine clearance ≤50 mL/min
• Hepatic function: Screening ALT or AST ≥3x than the upper limit of normal for the laboratory OR total bilirubin ≥2.0 mg/dL (Exception: acceptable if patient is identified with pre-existing condition e.g., Gilbert's disease that will contribute to baseline elevations of bilirubin)
• Pulmonary function: FEV1, FVC, DLCO ≤50% predicted
• Cardiac function: left ventricular ejection fraction ≤50%
• Patient received an investigational agent within 30 days prior to transplant
• The patient is pregnant, has a positive serum BhCG, or is lactating
• Patient on corticosteroids at a dose >0.25 mg/kg/day
• Planned non-myeloablative transplant
• Planned cord blood transplant
• Prior allogeneic myeloablative HSCT
• HIV seropositive, HTLV seropositive, hepatitis B or C seropositive, varicella virus active infection, or syphilis active infection
• Other serious medical or psychiatric illness that, in the investigator's opinion, would not permit the patient to be managed according to the protocol

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Oregon State University Medical Center — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• UZ Leuven — Leuven, Belgium

Full record on ClinicalTrials.gov

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