Status:
COMPLETED
Cellular Therapy With Cord Blood Cells
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Multiple Myeloma
Leukemia
Eligibility:
All Genders
Up to 80 years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The...
Detailed Description
Cord blood is a source of blood-forming cells that can be used for transplantation. Cord blood cells are taken from the umbilical cords of women who have given birth, and who have volunteered to donat...
Eligibility Criteria
Inclusion
- 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.
- Age up to 80 years.
- 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.
- 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.
- Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%.
- Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic heart disease.
- Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Diffusion Capacity (DLCO) \>40%.
- Serum creatinine \<2.0 mg/dL. Serum bilirubin \<3 \* upper limit of normal, SGPT \<4 \* upper limit of normal.
Exclusion
- Patients with active CNS disease
- Positive Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- 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.
- Evidence of chronic, active hepatitis or cirrhosis, or HIV
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00427557
Start Date
October 1 2006
End Date
November 1 2010
Last Update
May 28 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030