A Phase II Study of Umbilical Cord Blood Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00676806
• Date of registration: 09/05/2008
• Prospective Registration: No
• Primary sponsor: Tufts Medical Center
• Public title: A Phase II Study of Umbilical Cord Blood Transplantation
• Scientific title: A Phase II Study of Umbilical Cord Blood Transplantation Following Myeloablative or Reduced-Intensity Conditioning
• Date of first enrolment: July 2005
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00676806
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Andreas Klein, MD
• Affiliation: Tufts Medical Center

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Leukemia

Aplastic Anemia

Lymphoma

Multiple Myeloma

Intervention(s)

Biological: Umbilical Cord Blood After Myeloablative Conditioning

Biological: Umbilical Cord Blood After Reduced-Intensity Conditioning

Primary Outcome(s)

Number of Participants With Neutrophil Engraftment [Time Frame: +45 and 90 days]

Secondary Outcome(s)

Incidence of Chronic GVHD [Time Frame: After Day +100]

Infectious Complications in UCB Recipients. [Time Frame: Day +100]

Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation [Time Frame: +180 days]

Proportion of Subjects With Platelet Engraftment [Time Frame: +45, 90, and 180 days]

Incidence of Acute GVHD [Time Frame: Day +100]

Secondary ID(s)

UCBT001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00676806