Clinical Trials

Clinical Trial Detail

Return to search results.

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Complete title: Transplantation of Umbilical Cord Blood for Patients with Hematological Diseases with Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen

Research Study Number       2010.00
    
Principal Investigator       Colleen Delaney, MD, MSc
    
Phase       II

Look up trial at NIH

Research Study Description

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide (CY), fludarabine phosphate (FLU), and total-body irradiation (TBI) works in treating patients with hematologic disease. Giving chemotherapy, such as CY and FLU, and TBI before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

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

- GRAFT CRITERIA:

- ** UCB units will be selected according to current umbilical cord blood graft selection algorithm; one or 2 UCB units may be used to achieve the required cell dose

- ** The UCB graft is matched at 4-6 human leukocyte antigen (HLA)-A, B, DRB1 antigens with the recipient; this may include 0-2 antigen mismatches at the A or B or DRB1 loci; unit selection based on cryopreserved nucleated cell dose and HLA-A,B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing

- ** If 2 UCB units are required to reach the target cell dose, each unit must be a 4-6 antigen match to the recipient

- Acute myeloid leukemia:

- ** High risk first complete remission (CR1) as evidenced by preceding myelodysplastic syndromes (MDS), high risk cytogenetics (for example, monosomy 5 or 7), or high risk (HR) as defined by referring institution treatment protocol, >= 2 cycles to obtain complete response (CR), erythroblastic or megakaryocytic leukemia; >= second complete remission (CR2)

- ** 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%

- ** 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; these patients must be discussed with the principal investigator, Colleen Delaney prior to enrollment

- Very high risk pediatric/young adult patients with acute myeloid leukemia (AML): Patients =< 25 years, however, are eligible with (M2 marrow) with =< 25% blasts in marrow after having failed one or more cycles of chemotherapy; this group of patients will be analyzed separately

- Acute lymphoblastic leukemia:

- ** High risk CR1 [for example, but not limited to: t(9;22), t(1;19), t(4;11) or other mixed lineage leukemia (MLL) rearrangements, hypodiploid]

- ** Greater than 1 cycle to obtain CR

- ** >= CR2

- ** 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%

- ** 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; these patients must be discussed with the principal investigator, Colleen Delaney prior to enrollment

- 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

- Advanced myelofibrosis

- Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) Int-2 or high risk (i.e., refractory anemia with excess blasts [RAEB], RAEB in transformation [RAEBt]) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% by a representative bone marrow aspirate morphology

- Lymphoblastic lymphoma, Burkitt's lymphoma, and other high-grade non-Hodgkin lymphoma (NHL) after initial therapy if stage III/IV in first partial response (PR1) or after progression if stage I/II < 1 year; stage III/IV patients are eligible after progression in CR/PR

- Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma or follicular lymphoma that have progressed after at least two different prior therapies; patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant; these patients must be presented at primary care center (PCC) prior to enrollment, given potential competing eligibility on autotransplant protocols

- Mantle-cell lymphoma, prolymphocytic leukemia: Eligible after initial therapy in >= CR1 or >= PR1

- Large cell NHL > CR2/> second partial response (PR2):

- ** Patients in CR2/PR2 with initial short remission (< 6 months) are eligible

- ** These patients must be presented at PCC prior to enrollment, given potential competing eligibility on autotransplant protocols

- Multiple myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or beta-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy

- Performance status score: Karnofsky (for adults) >= 70% or Lansky (for children) >= 50%

- Creatinine < 2.0 mg/dL (for adults) or creatinine clearance > 60 ml/min (for children)

- 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 > 3 mg/dL, and symptomatic biliary disease will be excluded

- Diffusion capacity for carbon monoxide corrected (DLCOcorr) > 50% normal

- Left ventricular ejection fraction > 45% or shortening fraction > 26%

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Uncontrolled viral or bacterial infection at the time of study enrollment

- Active or recent (prior 6 month) invasive fungal infection without interdisciplinary (ID) consult and approval

- History of human immunodeficiency virus (HIV) infection

- Pregnant or breastfeeding

- Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)

- Prior myeloablative transplant containing full dose TBI (greater than 8 Gray [Gy])

- Any prior myeloablative transplant within the last 6 months

- Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation

- Patients who have received Y-90 ibritumomab (Zevalin) or I-131 tositumomab (Bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplant

Other exclusion criteria may apply.



Research Study Number       2010.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Acute Lymphoid Leukemia (ALL); Acute Myeloid Leukemia (AML); Acute Promyeloid Leukemia (APL); Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Burkitt's Lymphoma; Chronic Myeloid Leukemia (CML); Hematologic Malignancies; Hodgkin's Lympho

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.

Subscribe to an RSS feed of all trials

Fred Hutchinson Cancer Research Center is a world leader in research to prevent, detect and treat cancer and other life-threatening diseases.