Status:
TERMINATED
Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 45 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, natural killer cells, aldesleukin, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells and cance...
Detailed Description
OBJECTIVES: Primary * Determine the incidence of 6-month disease free survival. The primary laboratory objective is the measure of in vivo expansion of umbilical cord blood (UCB) derived natural kil...
Eligibility Criteria
Inclusion
- Diagnosis of 1 of the following:
- Acute myeloid leukemia with active leukemia (i.e., not in complete remission \[CR\]), defined by light microscopy (bone marrow) and having failed ≥ 1 round of standard chemotherapy
- Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after ≥ 1 course of standard chemotherapy and imatinib mesylate
- Myelodysplastic syndromes (MDS) or other myeloproliferative disorders more than 10% blasts after ≥ 1 course of standard chemotherapy
- Unrelated umbilical cord blood (UCB) donor(s) available - Each unit must be 4-6/6 HLA-A, -B, and -DRB1 matched with the recipient (and to each other if 2 units are utilized) (for UCB graft) AND 3/6 HLA-A, -B, and -DRB1 matched with the recipient (for UCB natural killer \[NK\] cells)
- Karnofsky performance status (PS) 80-100% (adult patients) or Lansky PS 50-100% (pediatric patients)
- Creatinine ≤ 2.0 mg/dL (adult patients) OR creatinine clearance \> 40 mL/min (pediatric patients)
- Bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
- Corrected Carbon Monoxide Diffusing Capacity (DLCO) \> 50% normal OR oxygen saturation \> 92% (in pediatric patients who cannot undergo pulmonary function tests)
- Left ventricular ejection fraction ≥ 45%
Exclusion
- Pregnant or nursing
- Positive pregnancy test (Fertile patients must use effective contraception)
- History of HIV infection
- Active infection at time of transplantation
- Active infection with Aspergillus or other mold within the past 120 days
- Less than 6 months since prior myeloablative transplant (≤ 18 years old)
- Prior myeloablative allotransplant or autologous transplant (\> 18 years old)
- No prior extensive therapy including \> 12 months of any alkylator chemotherapy or \> 6 months of alkylator therapy with extensive radiation (e.g., mantle irradiation for Hodgkin's lymphoma)
- Prior radiation therapy that would make the patient ineligible for total-body irradiation
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00354172
Start Date
February 1 2006
End Date
August 1 2008
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455