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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00427557 |
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Date of registration:
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25/01/2007 |
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Primary sponsor: |
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Public title:
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Cellular Therapy With Cord Blood Cells
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Scientific title:
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Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00427557 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Partow Kebriaei, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with multiple myeloma (MM), acute myeloid leukemia (AML), myelodysplastic
syndrome (MDS), acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma (NHL),
Hodgkin's lymphoma (HL), or chronic lymphocytic leukemia (CLL) in greater than first
complete remission who are candidates for a non-ablative or reduced intensity
conditioning regimen.
2. Age up to 80 years.
3. A related or unrelated donor who is HLA-matched at HLA, A, B, C, DR and DQ loci is
acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular
high-resolution technique per current standard for the BMT program). Donor must be
willing to donate peripheral blood or bone marrow progenitor cells.
4. Available cord blood unit must contain a minimum of 1.5 * 10^7 total nucleated cells
per kg, and be at least a 4/6 HLA match with patient.
5. Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%.
6. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic
heart disease.
7. Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and
Diffusion Capacity (DLCO) >40%.
8. Serum creatinine <2.0 mg/dL. Serum bilirubin <3 * upper limit of normal, SGPT <4 *
upper limit of normal.
Exclusion Criteria:
1. Patients with active CNS disease
2. Positive Beta HCG in a woman with child bearing potential defined as not
post-menopausal for 12 months or no previous surgical sterilization.
3. Serious medical or psychiatric illness likely to interfere with participation in this
clinical study, including but not limited to active uncontrolled infection,
uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major
depression, or mania.
4. Evidence of chronic, active hepatitis or cirrhosis, or HIV
Age minimum:
N/A
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leukemia
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Lymphoma
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Multiple Myeloma
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Intervention(s)
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Drug: Fludarabine
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Drug: Melphalan
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Drug: Rituximab
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Other: Peripheral Blood Stem Cell Infusion
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Procedure: Umbilical Cord Blood
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Primary Outcome(s)
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Number of Participants With Engraftment
[Time Frame: Baseline to 100 days post-engraftment]
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Secondary ID(s)
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2006-0553
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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