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

Healios

Status and phase

Completed

Phase 1

Conditions

Hematologic Malignancies

Treatments

Biological: MultiStem®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00677859

GVHD-2007-001

Details and patient eligibility

About

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.

Full 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 initiated by activation of donor T-cells through recognition of "foreign" cells resident in the transplant recipient. Acute GVHD is associated with damage to the liver, skin, gastrointestinal tract and mucosa. Moderate to severe GVHD Grades II-IV occurs in 30-50% of matched related HSCTs and 50-70% of unrelated donor recipients. Severe GHVD requires intense immunosuppression involving steroids and additional agents to get it under control, and patients may develop severe infections as a result of such immunosuppression. An agent or cell therapy that could reduce the incidence and/or severity of GVHD without increasing relapse or infectious risk in HSCT patients would provide substantial benefits.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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