Status:
COMPLETED
Safety Study of MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia
Lead Sponsor:
Healios K.K.
Collaborating Sponsors:
Cato Research
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 cel...
Detailed Description
Graft-vs.-Host Disease (GVHD) is one of the major limitations of allogeneic hematopoietic stem cell transplants (HSCT). This complication is major cause of morbidity and mortality and is thought to be...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00677859
Start Date
July 1 2008
End Date
November 1 2011
Last Update
January 5 2012
Active Locations (6)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
3
Oregon State University Medical Center
Portland, Oregon, United States, 97239
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104