Skip to Content

Vanderbilt-Ingram Cancer CenterVanderbilt-Ingram Cancer Center

 

Learn More

VICC toll-free number 1-877-936-8422

Clinical Trial VICCPED1355

Title

Multi-Center, Open-Label Ranodomized Study of Single or Double Myleoablative Cord Blood Transplantation With or Without Infusion of Off-the-Shelf Ex Vivo Expanded Cyropreserved Cord Blood Progenitor Cells in Patients with Hematologic Malignancies

Principal Investigator(s)

Haydar Frangoul

Details

  • Protocol No. VICCPED1355
  • Open Date: 03/05/2014
  • Staging: Phase II
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: Compare the time to neutrophil engraftment (ANC>/=500) in patients receiving a standard of care myeloablative CBT augmented with an off-the-shelf pre-expanded and cryopreserved cord blood product to those who do not receive the product.
  • Disease Sites: None Specified
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics; Therapy (NOS)
  • Drugs: Cyclophosphamide (CTX); Cyclosporine; DCC-UCB; Fludarabine (Fludara); G-CSF; Mycophenolate Mofetil (MMF)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01690520
  • Secondary Protocol No: FHCRC 2603

Description

None Provided.

Eligibility

Ages Eligible for Study:6 Months to 45 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Acute myeloid leukemia
• High risk first complete remission (CR1) as evidenced by preceding myelodysplastic syndromes (MDS), high risk cytogenetics (for example, monosomy 5 or 7, or as defined by referring institution treatment protocol), >= 2 cycles to obtain complete remission (CR), erythroblastic or megakaryocytic leukemia; >= second complete remission (CR2)
• All patients must be in CR as defined by < 5% blasts by morphology/flow cytometry in a representative bone marrow sample with cellularity >= 15% for age
• Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible; reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures; these patients must be discussed with the principal investigator prior to enrollment
• Acute Lymphoblastic Leukemia
• High risk CR1 (for example, but not limited to: t(9;22), t(1;19), t(4;11) or other mixed-lineage leukemia [MLL] rearrangements, hypodiploid); or high risk (HR) as defined by referring institution treatment protocol greater than 1 cycle to obtain CR; CR2 or greater
• All patients must be in CR as defined by < 5% blasts by morphology/flow cytometry in a representative bone marrow sample with cellularity >= 15% for age
• Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible; reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures; these patients must be discussed with the principal investigator prior to enrollment
• Chronic myelogenous leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy
• Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or High risk (i.e., refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBt]) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% by a representative bone marrow aspirate morphology
• Karnofsky (>= 16 years old) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1
• Lansky (< 16 years old) >= 60
• Adults: calculated creatinine clearance must be > 60 mL and serum creatinine =< 2 mg/dL
• Children (< 18 years old): calculated creatinine clearance must be > 60 mL/min
• Total serum bilirubin must be < 3mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
• Transaminases must be < 3 x the upper limit of normal per reference values of referring institution
• Diffusing capacity of the lung for carbon monoxide (DLCO) corrected > 60% normal
• For pediatric patients unable to perform pulmonary function tests, oxygen (O2) saturation > 92% on room air
• May not be on supplemental oxygen
• Left ventricular ejection fraction > 45% OR
• Shortening fraction > 26%
• Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
• Uncontrolled viral or bacterial infection at the time of study enrollment
• Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
• History of human immunodeficiency virus (HIV) infection
• Pregnant or breastfeeding
• Prior myeloablative transplant containing full dose TBI (greater than 8 Gy)
• Any prior myeloablative transplant within the last 6 months
• Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of conditioning; diagnostic lumbar puncture is to be performed per protocol