The PUMA Trial is a Trial of a Single ProHema Modulated-CB Unit as Part of a Double CB Transplant in Patients With Hematologic Malignancies.



Status:Terminated
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:15 - 65
Updated:4/21/2016
Start Date:July 2012
End Date:December 2016

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A Phase 2 Controlled Trial of a Single ProHema®-CB Unit (Ex Vivo Modulated Human Cord Blood) As Part of a Double Umbilical Cord Blood Transplant Following Myeloablative or Reduced Intensity Conditioning For Patients Age 15-65 Years With Hematologic Malignancies.

This study is an open-label randomized, prospectively and historically controlled trial of
the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant
following myeloablative or reduced intensity conditioning for subjects age 15-65 years with
hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in
the trial at approximately 10 centers within the U.S.

All subjects will receive a myeloablative or reduced intensity conditioning regimen, after
which they will receive 2 HLA-matched UCB units. A total of 40 subjects will receive one
ProHema-CB as part of a double CB transplant and an additional 20 subjects will be enrolled
as concurrent controls. The determination of which CB unit will be the ProHema-CB unit will
be made based primarily upon the degree of HLA match.

Inclusion Criteria:

1. Subjects with hematologic malignancies for whom allogeneic stem cell transplantation
is deemed clinically appropriate. Eligible diseases and stages include:

- Acute lymphoblastic leukemia (including T lymphoblastic leukemia) in complete
remission.

- Remission is defined as < 5% blasts with no morphological characteristics of
acute leukemia in a bone marrow with > 20% cellularity.

- Acute myelogenous leukemia in high risk first CR or second or subsequent CR.

- High risk first CR is defined by but is not limited to at least one of the
following factors: greater than 1 cycle of induction chemotherapy to achieve CR,
prior myelodysplastic syndrome (MDS), presence of Flt3 abnormalities, FAB M6 or
M7 subtypes of leukemia, or adverse cytogenetics.

- Remission is defined as < 5% blasts with no morphological characteristics of
acute leukemia (e.g. Auer Rods) in a bone marrow with > 20% cellularity.

- Biphenotypic/Undifferentiated leukemia in first or subsequent CR (same
definition of CR as for ALL/AML).

- Non-Hodgkin's lymphoma (T-cell, large cell or mantle cell) or Hodgkin's lymphoma
in second or subsequent complete remission (CR) or in partial remission (PR)
with documented chemosensitivity. In addition, marginal zone lymphoma or
follicular lymphoma that has progressed after ≥ 2 therapies (excluding
single-agent rituximab). No history of prior myeloablative procedure.

2. Lack of suitable 5-6/6 HLA-matched related or (if institutional guidelines dictate)
suitable 8/8 HLA-A, B, C, DRß1 matched unrelated donor; or unrelated donor not
available within appropriate timeframe.

3. Age 15-65 years.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

5. Signed IRB approved Informed Consent Form (ICF).

Exclusion Criteria:

1. History of prior allogeneic transplantation

2. Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
dysfunction (Ejection fraction < 40%) as measured by gated radionuclide
ventriculogram or echocardiogram; active angina pectoris, or uncontrolled
hypertension; history of myocardial infarction with depressed ejection fraction.

3. Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for
hemoglobin.

4. Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40
mL/min.

5. Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's
syndrome or ongoing hemolytic anemia), SGOT or SGPT > 5 x upper limit of normal.

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

7. HIV antibody.

8. Uncontrolled infection.

9. Pregnancy or breast feeding mother.

10. Inability to comply with the requirements for care after allogeneic stem cell
transplantation.
We found this trial at
10
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Christine Duncan, M.D.
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Karen Ballen
Phone: 617-724-9190
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Daniel Couriel, M.D.
Phone: 734-615-6872
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
Principal Investigator: Edmund Waller, MD
Phone: 404-778-3708
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Boston, Massachusetts 02215
Principal Investigator: Corey Cutler
Phone: 617-632-6808
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Columbus, Ohio 43210
Principal Investigator: Sumithira Vasu, MD
Phone: 614-293-7934
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Duarte, California 91010
Principal Investigator: Chatchada Karanes,, MD
Phone: 626-256-4673
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Duarte, CA
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Patrick Stiff, MD
Phone: 708-327-2241
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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New York, New York 10029
Principal Investigator: Luis Isola, MD
Phone: 212-241-0497
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Portland, Oregon
Principal Investigator: Richard Maziarz, MD
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Portland, OR
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