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Transplantation of Umbilical Cord Blood Following Chemotherapy for Blood Cancers

This study has been terminated.
(The manufacturer discontinued necessary reagents.)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00539656
First received: October 2, 2007
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Leukemia, Lymphoblastic, Acute
Leukemia, Bilineage, Acute
Leukemia, Myeloid, Chronic
Device: Ex vivo expansion of cord blood
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Expanded and Unexpanded Umbilical Cord Blood Units Following Myeloablative Chemotherapy for Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Toxicities related to Infusion of Expanded Cord Blood Products [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Neutrophil Engraftment within 21 days [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-relapse mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: October 2007
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539656

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

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00539656     History of Changes
Other Study ID Numbers: J0606, NA00001903
Study First Received: October 2, 2007
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 31, 2014