Transplantation of Umbilical Cord Blood Following Chemotherapy for Blood Cancers (Cord Blood)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539656
Recruitment Status : Terminated (The manufacturer discontinued necessary reagents.)
First Posted : October 4, 2007
Last Update Posted : October 28, 2013
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This study is to evaluate the safety of transplantation of two cord blood products, including toxicities in patients following high-dose, myeloablative chemotherapy for blood malignancies. It is also to determine if the use of two cord products results in an improvement in neutrophil engraftment.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Leukemia, Lymphoblastic, Acute Leukemia, Bilineage, Acute Leukemia, Myeloid, Chronic Device: Ex vivo expansion of cord blood Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Expanded and Unexpanded Umbilical Cord Blood Units Following Myeloablative Chemotherapy for Hematologic Malignancies
Study Start Date : October 2007
Actual Primary Completion Date : December 2010

Intervention Details:
  • Device: Ex vivo expansion of cord blood
    One cord blood unit will be thawed on day -14 before transplantation and selected using the CliniMACS for primitive cells that express CD133. These cells will be expanded ex vivo for a total of 14 days, using a two-stage procedure. On Day 0 the expanded cells will be harvested, washed three times with CliniMACS buffer (Miltenyi) plus 1% HSA per standard laboratory and clinical practice and the expanded cell product will be infused to a patient who has been prepared with a standard, myeloablative preparative regimen. A second, unexpanded, cord blood product will be infused on Day +1 for safety.
    Other Name: Miltenyi CliniMACS CD133

Primary Outcome Measures :
  1. Toxicities related to Infusion of Expanded Cord Blood Products [ Time Frame: 7 days ]
  2. Neutrophil Engraftment within 21 days [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Non-relapse mortality [ Time Frame: 100 days ]

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Ages Eligible for Study:   6 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must have two cord units available. Units must be minimally matched to the subject at 4/6 antigens (HLA Class I (A or B) and Class II (DRB1) - units must have at lease one HLA DRB1 matched allele) and at least one unit must contain a minimum of 1.0 x 107 Total Nucleated Cells /Kg but neither unit may have > 5 x 107Total Nucleated Cells /Kg. (The feasibility of using particular units will be discussed with the Principal Investigators)
  • Disease status precludes waiting to identify a suitably HLA matched unrelated donor
  • Patients must have a diagnosis of one of the following:

AML , refractory AML, Secondary AML ALL in CR2 with high-risk features such as short CR1 and/or high- risk cytogenetics ALL in CR1 following initial induction failure Acute mixed lineage leukemia CML beyond chronic phase 1. Lymphoma (Hodgkins or Non-Hodgkins) ineligible for Autologous- BMT Myelodysplastic Syndrome

  • Able to provide informed consent or parent/guardian able to provide informed consent.

Exclusion Criteria:

  • Consenting 5/6 or 6/6 HLA matched related donor available
  • Single cord blood product with cell count >5 x10E7 Total Nucleated Cells/kg
  • Poor Performance Status ECOG performance status >= 2 (Karnofsky or Lansky Play performance<70).
  • Poor Cardiac Function (obtained within 3 weeks of the start of transplant):

Left ventricular ejection fraction <= 45% as determined by MUGA or ECHO. For pediatric patients LVEF < 45 % or a Shortening Fraction below normal limits for age.

  • Poor Pulmonary Function (obtained within 3 weeks of the start of transplant):

FEV1 and FVC <50% of predicted for patients who have not received thoracic or mantle irradiation.

For patients who have received thoracic or mantle irradiation, FEV1 and FVC <= 75% of predicted or DLCO <= 50% of predicted For children unable to perform PFTs second to developmental stage, Pulse oximetry <= 85% on RA

  • Poor Liver Function (obtained within 1 week of the start of transplant):

Bilirubin >= 2.0 mg/dl. (with the exception of patients whose hyperbilirubinemia is the result of Gilbert's disease)

  • Poor Renal Function (obtained within 3 weeks of the start of transplant):

Corrected CrCl < 60 mg/min. CrCl will be estimated by the Schwartz formula. A measured CrCl or a GFR may be substituted to determine the subject's CrCl

  • HIV Infection Patients who are HIV positive. (The role of allogenic transplant in HIV+ individuals has not been studied)
  • Pregnancy Patients who are pregnant. (The chemotherapeutic agents used in bone marrow transplant are teratogenic)
  • Uncontrolled viral, bacterial or fungal infections
  • Patients with symptoms consistent with RSV, influenza A, B or parainfluenza at the time of enrollment on this study will be assayed for the above viruses and if positive are not eligible for the trial until are no longer symptomatic (patients may have continued assay positivity for a period of time post resolution of symptoms second to the nature of the assay)
  • Presence of concomitant medication or incident condition that would create an unreasonable risk for the subject to participate in this study as determined by the investigators (Primary or co-investigators).
  • Patients with known intolerance to or contraindication for any agent that will be used in the subject's proposed myeloablative or required supportive care regimen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539656

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator: Allen R. Chen, MD,PhD. MHS Johns Hopkins University

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00539656     History of Changes
Other Study ID Numbers: J0606
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Cord blood stem cell transplantation
Ex vivo expansion
Alternative donor

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases