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Bone Marrow Transplant

Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant (FHCRC-2378)
Infusion of Off-the-Shelf Ex-Vivo Expanded Cryopreserved Cord Blood Progenitor Cells to Augment Single or Double Myeloablative Cord Blood Transplantation in Patients with Hematologic Malignancies
Status Conditions Phase Study ID
Closed Acute Lymphoid Leukemia (ALL); Chronic Myeloid Leukemia (CML); Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD); Umbilical Cord Blood Transplant (UCBT) Phase II FHCRC-2378
NCT01175785
Summary

RATIONALE: Chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red blood cells, white blood cells, and platelets. It may take several weeks for these new blood cells to grow. During that period of time, patients are at increased risk for bleeding and infection. Faster recovery of white blood cells may decrease the number and severity of infections. Studies have shown that counts recover more quickly when more cord blood cells are given with the transplant. The investigators have developed a way of growing or "expanding" the number of cord blood cells in the lab so that there are more cells available for transplant. The investigators are doing this study to find out whether or not giving these expanded cells along with one or two unexpanded cord blood units is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant. The investigators will study the time it takes for blood counts to recover, which of the two or three cord blood units makes up the patient's new blood system, and how quickly immune system cells return.

PURPOSE: This phase II trial is studying the safety and potential efficacy of infusing non-HLA matched ex vivo expanded cord blood progenitors with one or two unmanipulated umbilical cord blood units for transplantation following conditioning with fludarabine, cyclophosphamide and total body irradiation, and immunosuppression with cyclosporine and mycophenolate mofetil for patients with hematologic malignancies.


Investigator
Colleen Delaney, MD, MSc
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

 

Ages Eligible for Study:   6 Months to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Acute Myeloid Leukemia: a) High risk CR1 as evidenced by preceding MDS, high risk cytogenetics (for example, monosomy 5 or 7, or as defined by referring institution treatment protocol), > 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia; >= CR2; b) All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of >= 15%; c) Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible (Reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures)
  • Acute Lymphoblastic Leukemia: a) High risk CR1 [for example, but not limited to: t(9;22), t(1;19), t(4;11) or other MLL rearrangements, hypodiploid]; b) Greater than 1 cycle to obtain CR; c) Greater than CR2; d) All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of > 15%; d) Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible (Reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures)
  • Chronic myelogenous leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate
  • Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e., RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% by a representative bone marrow aspirate morphology
  • Karnofsky (>= 16 years old) >= 70%
  • Lansky (< 16 years old) >= 50%
  • Adults: Serum creatinine =< 2.0 mg/dL and creatinine clearance > 60 mL/min
  • Children (< 18 years old): Creatinine clearance must be > 60 mL/min
  • Total serum bilirubin < 3mg/dl and transaminases < 3x the upper limit of normal; patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3mg/dL, and symptomatic biliary disease will be excluded
  • DLCO corrected > 50% normal
  • For pediatric patients unable to perform pulmonary function tests, O2 saturation > 92% on room air
  • Left ventricular ejection fraction > 45% OR shortening fraction > 26%
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion

  • Uncontrolled viral or bacterial infection at the time of study enrollment
  • Active or recent (prior 6 month) invasive fungal infection without ID consult and approval
  • History of HIV infection
  • Pregnant or breastfeeding
  • If =< 18 years old, prior myeloablative transplant within the last 6 months
  • If > 18 years old prior myeloablative allotransplant or autologous transplant
  • Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation
Last Updated
March 13, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.