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

NCT00677859 | Completed Phase 1 DMC

• 1 other identifier: GVHD-2007-001
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 6

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 cell transplantation.

Conditions

Hematologic Malignancies

Keywords

Leukemia; Graft vs. Host Disease; Hematopoietic Stem Cell Transplant; Bone Marrow Transplant; Myelodysplasia

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose

  30 days

Secondary Outcomes (1)

• incidence of grade III/IV GVHD

  100 days

Study Arms (2)

Single dose Arm

EXPERIMENTAL

There will be six cohorts of three patients each. Three escalating doses of MultiStem will be evaluated.

Biological: MultiStem®

Repeat Dose Arm

EXPERIMENTAL

There will be six cohorts of three patients each. Four dosing regimens will be evaluated,varying doses at three times weekly or five times weekly.

Biological: MultiStem®

Interventions

MultiStem® BIOLOGICAL

Patients will receive a single IV infusion of MultiStem® 2 days after HSCT.

Single dose Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Healios K.K.: lead
• Cato Research: collaborator

Study Sites (6)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon State University Medical Center

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Graft vs Host Disease; Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Immune System Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Officials

• Richard Maziarz, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Steven Devine, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Hillard Lazarus, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 15, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

US (5); BE (1)