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A Phase 2, Controlled Trial, Of A Single Prohema-CB Unit (Ex Vivo CXCR4-Upregulated CD34+ Hematopoietic Progenitor Cells, Cord Blood) As Part Of A Double Umbilical Cord Blood Transplant Following Myeloablative Conditioning For Patients Age 15-55 Years With Hematologic Malignancies


Phase 2
15 Years
55 Years
Open (Enrolling)
Both
Hematologic Malignancies

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Trial Information

A Phase 2, Controlled Trial, Of A Single Prohema-CB Unit (Ex Vivo CXCR4-Upregulated CD34+ Hematopoietic Progenitor Cells, Cord Blood) As Part Of A Double Umbilical Cord Blood Transplant Following Myeloablative Conditioning For Patients Age 15-55 Years With Hematologic Malignancies


All subjects will receive a myeloablative conditioning regimen, after which they will
receive 2 HLA-matched UCB units. A total of 30 subjects will receive one ProHema-CB as part
of a double CB transplant and an additional 15 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 15-55 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neutrophil engraftment/chimerism

Outcome Description:

To determine the rate of neutrophil engraftment by Day 26 after a single ProHema-CB unit is used as part of a double CB transplant following myeloablative conditioning for subjects age 15-55 years with hematologic malignancies.

Outcome Time Frame:

Day 26

Safety Issue:

No

Principal Investigator

Pratik Multani, MD

Investigator Role:

Study Director

Investigator Affiliation:

Fate Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

FT1050-03

NCT ID:

NCT01627314

Start Date:

July 2012

Completion Date:

December 2014

Related Keywords:

  • Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Massachusetts General HospitalBoston, Massachusetts  02114-2617
City of HopeDuarte, California  91010
Oregon Health SciencesPortland, Oregon  97201
Mount Sinai HospitalNew York, New York  10029
Ohio State University Comprehensive Cancer CenterColumbus, Ohio  
Dana-Farber Cancer Institute- Hematopoietic Stem Cell Transplant ProgramBoston, Massachusetts  02215