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There are three chemotherapy drugs involved. They are called fludarabine (5 doses), cyclophosphamide (1 dose), and thiotepa (2 doses). Also two days of radiation therapy. This is called Total Body Irradiation or TBI. The TBI if given for two days before, the transplant. On transplant day, the cord blood cells will be given through a catheter. The immune suppressing drugs given are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through the catheter. Later they can be given as tablets.

Cyclophosphamide 50 mg/kg/dose x 1 IV day -6 (1 dose) Fludarabine 30 mg/m2/dose x 5 IV days -6 to -2 (5 doses) Thiotepa 5 mg/kg/dose x 2 IV days -5 to -4 (2 doses) TBI 200 cGy/dose x 2 days -2 to -1 (2 doses). On transplant day, the cord blood cells will be given through your catheter. The immune suppressing drugs you will receive are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through your catheter. Later they can be given as tablets.

fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft

Juliet Barker, MBBS

The traditional way of doing a donor transplant is to give high doses of chemotherapy and radiation before giving the stem cells. However, high doses of chemotherapy and radiation can have serious side-effects. The doctors think that the transplant will be safer and more likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this study is to find out how good a combination of chemotherapy and radiation at reduced doses followed by a cord blood transplant are at treating cancer.

The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood is collected from healthy newborn babies and frozen. One cord blood collection is called a "cord blood unit." On transplant day, the cord blood will be given through the catheter just like a blood transfusion. Transplants done this way have been successful. However, this type of transplant is fairly new. Therefore, it is important to study it so the doctors can better understand how it works.

Most blood or bone marrow transplants using donor stem cells are done as part of a study. When patients are on a study we test new ways of treating them which we think may be better than the old ways. We collect information about the result of this treatment so we can understand how well the treatment works. This is so we can learn better ways to treat our patients.

Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

A Reduced Intensity Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

To obtain a preliminary estimate of progression free survival at 1 year post UCBT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Successful primary donor engraftment = neutrophill recovery within the first 45 days after transplant and partial/complete donor chimerism (\>/= 10%)

The day 100 cumulative incidence of sustained CB-derived neutrophil engraftment.

The day 100 cumulative incidence of sustained CB-derived platelet engraftment to \>/= 20 x 10\^9/L

Memorial Sloan Kettering Cancer Center

Participants With Hematologic Malignancies

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Progression Free Survival/PFS at 1 Year Post UCBT.

Haplo-dCBT with early haplo-derived myeloid bridge

Haplo-dCBT with transient haplo-derived bridge with second neutrophil nadir

Haplo-dCBT with no bridge

Remaining dCBT recipient

43 haplo-dCBT recipients in this analysis 43 dCBT recipient

Number of Participants With Neutrophil Recovery Post Allograft for Haplo-dCBT Recipients

Percentage of Participants With Sustained CB-derived Neutrophil Engraftment

Percentage of Participants With Sustained CB-derived Platelet Engraftment

Overall Study

Spots Global Cancer Trial Database for fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft