Trial Search Results

Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes

This randomized phase II trial studies how well donor umbilical cord blood transplant with or without ex-vivo expanded cord blood progenitor cells works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy stem cells and ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded cord blood progenitor cells is more effective than giving a donor umbilical cord blood transplant alone.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Nohla Therapeutics, Inc.

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Cyclophosphamide
  • Drug: Cyclosporine
  • Biological: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
  • Drug: Fludarabine Phosphate
  • Drug: Mycophenolate Mofetil
  • Drug: Thiotepa
  • Radiation: Total-Body Irradiation
  • Procedure: Umbilical Cord Blood Transplantation

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Age criteria:

      - High dose TBI regimen: 6 months to =< 45 years

      - Middle intensity TBI regimen: 6 months to =< 65 years

      - Conditioning regimen selection should be based on the underlying disease,
      presence of minimal residual disease (MRD), age, co-morbidities, attending
      physician, and site preference; conditioning regimen will not require
      stratification of the randomization due to heterogeneity in the cohort of
      eligible patients.

   - Acute myeloid leukemia, including biphenotypic acute leukemia or mixed-lineage
   leukemia

      - All patients must have acute myeloid leukemia (AML) that is considered best
      treated by stem cell transplant by the referring physician and the attending
      transplant physician

      - All patients must be in complete remission (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, including biphenotypic acute leukemia or mixed-lineage
   leukemia

      - High risk first complete remission (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; second complete remission (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 < 3 mg/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)

   - 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

   - Patients >= 45 years: comorbidity score of 5 or higher

Ages Eligible for Study

6 Months - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting