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A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

Phase 2
18 Years
70 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, Acute Myelogenous Leukemia

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Trial Information

A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

Subjects will receive their transplants as in-patients.

- IV-Catheter

- one or two IV catheters will be placed on the day of hospital admission

- Conditioning

- Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)

- Melphalan IV (day -1)

- Total body radiation on day 0 (same day as transplant)

- Immunosuppressive Therapy

- Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant.
Given IV as in-patient, orally as out-patient

- Infusion of Cord Blood units

- 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be

Inclusion Criteria:

- Hematologic malignancy for whom allogeneic stem cell transplantation is deemed
clinically appropriate

- Appropriate candidate for reduced intensity regimen, according to the treating

- Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or
unrelated donor not available with a time frame necessary to perform a potentially
curative stem cell transplant

- Able to comply with the requirements for care after allogeneic stem cell

Exclusion Criteria:

- Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular

- Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
restrictive lung disease

- Renal disease

- Hepatic disease

- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation

- HIV-positive

- Uncontrolled infection

- Pregnant or breast-feeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

One year significant viral infection rate

Outcome Description:

To determine the one year significant viral infection rate (viral infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation

Outcome Time Frame:

2.5 years

Safety Issue:


Principal Investigator

Karen Ballen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

January 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • NHL
  • lymphoma
  • leukemia
  • myelodysplastic disorder
  • aplastic anemia
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617