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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fate Therapeutics
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics
ClinicalTrials.gov Identifier:
NCT01627314
First received: June 21, 2012
Last updated: June 11, 2014
Last verified: June 2014

June 21, 2012
June 11, 2014
July 2012
May 2015   (final data collection date for primary outcome measure)
Neutrophil engraftment/chimerism [ Time Frame: before Day 60 ] [ Designated as safety issue: Yes ]
To determine the rate of neutrophil engraftment after a single ProHema-CB unit is used as part of a double CB transplant.
Neutrophil engraftment/chimerism [ Time Frame: Day 26 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01627314 on ClinicalTrials.gov Archive Site
Neutrophil engraftment [ Time Frame: before Day 180 ] [ Designated as safety issue: No ]
To define measures of engraftment, including time to neutrophil engraftment, cumulative incidence of neutrophil engraftment by Day 42, time to platelet engraftment (> 20K and > 50K), cumulative incidence of platelet engraftment, and rates of primary and secondary graft failure
Neutrophil engraftment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
To define measures of engraftment, including time to neutrophil engraftment, cumulative incidence of neutrophil engraftment by Day 42, time to platelet engraftment (> 20K and > 50K), cumulative incidence of platelet engraftment by Day 180, and rates of primary and secondary graft failure
Not Provided
Not Provided
 
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.
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematologic Malignancies
  • Biological: ProHema-CB
    Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
  • Biological: Untreated CB
    Cord Blood
  • Experimental: ProHema-CB
    Intervention: Biological: ProHema-CB
  • Active Comparator: Control Arm
    Intervention: Biological: Untreated CB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
15 Years to 65 Years
No
Contact: John Ferraro 858-875-1806 john.ferraro@fatetherapeutics.com
Contact: Pratik Multani, M.D. 858-875-1810
United States
 
NCT01627314
FT1050-03
Yes
Fate Therapeutics
Fate Therapeutics
Not Provided
Study Director: Pratik Multani, MD Fate Therapeutics
Fate Therapeutics
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP