A Phase II Study of Umbilical Cord Blood Transplantation

This is an interventional treatment trial for Leukemia focused on measuring Umbilical cord blood transplantation, full ablation conditioning, reduced intensity conditioning Read More

Inclusion Criteria:

Patients meeting eligibility criteria for unrelated allogeneic stem cell transplantation may be considered for participation on this clinical trial if and only if they meet each of the following criteria:

• Patients must have one of the following diagnoses
• Relapsed or refractory hematologic malignancy, or
• High risk hematologic malignancy in first remission, or
• Refractory acquired marrow failure state, or
• Inherited disorder of metabolism or marrow failure state without alternative curative therapy.
• Patients must not have a 6/6 or 5/6 HLA-matched related donor.
• Patients must not have a HLA-A, -B and -DRB1 high resolution matched unrelated donor following registry search, or cannot (in the opinion of the treating physician) wait the median 3 months to receive a MUD unit.
• Patients must demonstrate an ability to understand and willingness to sign the informed consent document

Patients considered for myeloablative conditioning must satisfy the following additional criteria:

• Patients must be up to age 55 (inclusive)
• Patients must have serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 2x institution upper limit of normal
• Patients must have serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or measured).
• Patients must have MUGA scan or echocardiogram normal for the institution, but not less than 45% left ventricular ejection fraction and no clinical evidence of cardiac dysfunction.
• Patients must have an ECOG performance status of 0 or 1 (see Appendix C).
• Patients must have adequate pulmonary function when corrected for hemoglobin and alveolar volume as evidenced by a diffusion capacity and FEV1 > 50% of predicted.

Patients considered for reduced-intensity conditioning must satisfy the following additional criteria:

• Patients must not be candidates for myeloablative conditioning due to any one of the following: Prior myeloablative stem cell transplantation, Age > 50, Co morbid illness
• In opinion of treating physician, unable to comply with or withstand rigors of myeloablative conditioning
• Patients with leukemia must have circulating and bone marrow blast counts < 5%, all other patients must have chemotherapy responsive disease
• Patients must be between the ages of 18 and 70 (inclusive)
• Patients must have serum direct bilirubin ≤ 2.0 mg/dL and transaminases ≤ 3x institution upper limit of normal
• Patients must have creatinine clearance ≥ 30 ml/min (either calculated or measured).
• Patients must have MUGA scan or echocardiogram documenting left ventricular ejection fraction of no less than 35% and no clinical evidence of cardiac dysfunction.

Patients must have an ECOG performance status of 0 or 1 (see Appendix C).

Patients must have adequate pulmonary function when corrected for hemoglobin and alveolar volume as evidenced by a diffusion capacity and FEV1 ≥ 40% of predicted.

Exclusion Criteria:

Patients are ineligible for participation on this trial if they meet any of the following criteria:

• Patients with a history of myocardial infarction within the preceding 6 months, significant arrhythmia within the preceding 3 months, uncontrolled hypertension or congestive heart failure are ineligible.
• Patients with unstable angina are not eligible.
• Pregnant or lactating women are ineligible.
• Male and female patients who do not agree to practice approved methods of birth control for the duration of the study are ineligible.
• Patients with uncontrolled infection are ineligible.
• Patients who are HIV positive or have evidence of chronic viral hepatitis are ineligible.
• Patients unable to comply with requirements for compliance with therapeutic plan and/or scheduled evaluations