A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies

Who is this study for? Adult patients with Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
What treatments are being studied? ProTmune Ex Vivo Programmed Mobilized Peripheral Cells
Status: Completed
Location: See all (15) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male and female patients aged 18 years and older, inclusive;

• Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate.

• Eligible diseases and stages include the following:

‣ Acute myeloid leukemia

‣ Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement

‣ Myelodysplastic Syndrome

‣ Chronic myelogenous leukemia

• Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;

• mBP donor collection that meets protocol specifications;

• Adequate performance status, defined as Karnofsky score greater than or equal to 70%;

• For female patients of childbearing potential, all of the following criteria must be met:

‣ They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);

⁃ They are not breastfeeding;

⁃ They do not plan to become pregnant during the study; and

⁃ They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile.

• For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and

• Willingness and ability to sign an IRB/IEC-approved ICF before performance of any study-specific procedures or tests and to comply with protocol visits, and study procedures.

Locations
United States
Alabama
University of Alabama
Birmingham
California
City of Hope
Duarte
University of California, San Diego (UCSD) Moores Cancer Center
San Diego
Illinois
University of Chicago
Chicago
Indiana
Indiana Blood and Marrow Transplant
Indianapolis
Massachusetts
Dana Farber Cancer Institute
Boston
Michigan
Barbara Ann Karmanos Cancer Institute
Detroit
New York
Weill Cornell Medicine
New York
Ohio
Jewish Hospital
Cincinnati
The Ohio State University
Columbus
Oregon
Oregon Health & Science University
Portland
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
Texas Transplant Institute
San Antonio
Utah
Huntsman Cancer Institute (University of Utah)
Salt Lake City
Virginia
Virginia Commonwealth University
Richmond
Time Frame
Start Date: 2016-12-20
Completion Date: 2021-11-05
Participants
Target number of participants: 96
Treatments
Experimental: ProTmune
Conditioning regimen consisting of one of the following five preparative regimens: fludarabine and busulfan (FluBu4); busulfan (Bu) and cyclophosphamide (Cy); Cy and \>or=12 Gy total body irradiation (TBI); TBI and etoposide; or fludarabine and melphalan (FluMel 140).~Subjects will receive mPB cells from an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor that were programmed ex vivo with ProTmune.
Active_comparator: Control Arm
Conditioning regimen consisting of one of the following five preparative regimens: fludarabine and busulfan (FluBu4); busulfan (Bu) and cyclophosphamide (Cy); Cy and \>or=12 Gy total body irradiation (TBI); TBI and etoposide; or fludarabine and melphalan (FluMel 140).~Subjects will receive unmanipulated mPB cells from an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor.
Sponsors
Leads: Fate Therapeutics

This content was sourced from clinicaltrials.gov