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Phase I Study of Sequential Cord Blood Transplants

Phase 1
65 Years
Not Enrolling
Lymphoma, Leukemia, Multiple Myeloma, Myelodysplastic Syndrome

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Trial Information

Phase I Study of Sequential Cord Blood Transplants

Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days,
melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD
prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil
starting on day 0. Sequential cord blood units will be infused on Day 0.

Inclusion Criteria:

- Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage
III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2
chemotherapy regimens; AML or ALL in second or subsequent remission or in first
remission with adverse cytogenetics or antecedent hematologic disorder

- Estimated disease-free survival of less than one year

- ECOG performance status of 0, 1, 2

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

- 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose
from of > 3.7 x 10(7) NC/kg

Exclusion Criteria:

- Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram
determined left ventricular ejection fraction of < 45%, active angina pectoris, or
uncontrolled hypertension

- Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic
restrictive lung disease, or corrected DLCO of < 50%

- Renal disease: serum creatinine > 2.0 mg/dl

- Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's
syndrome), SGPT or SGOT > 3 x normal

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

- HIV antibody or Hepatitis B surface antigen positivity

- Uncontrolled infection

- Pregnancy or breast-feeding mother

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Karen Ballen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital, Harvard University


United States: Institutional Review Board

Study ID:




Start Date:

May 2003

Completion Date:

May 2009

Related Keywords:

  • Lymphoma
  • Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia



Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana Farber Cancer Institute Boston, Massachusetts  02115