Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02743351
Other study ID # PT-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 20, 2016
Est. completion date November 5, 2021

Study information

Verified date December 2022
Source Fate Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date November 5, 2021
Est. primary completion date December 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: 1. Male and female patients aged 18 years and older, inclusive; 2. 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: 1. Acute myeloid leukemia 2. Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement 3. Myelodysplastic Syndrome 4. Chronic myelogenous leukemia 3. Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor; 4. mBP donor collection that meets protocol specifications; 5. Adequate performance status, defined as Karnofsky score greater than or equal to 70%; 6. 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. 7. For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and 8. 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. Key Exclusion Criteria: 1. Phase 1 only: Known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 (severe) or greater; 2. Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at any time prior to enrollment; 3. Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy); 4. Prior autologous or allogeneic HCT; 5. Active malignancy, other than the one for which the allogeneic mPB transplant is being performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma in situ cervical cancer; 6. Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease; 7. Participation in another clinical trial involving an investigational product within 30 days prior to screening; or 8. Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.

Study Design


Intervention

Biological:
ProTmune
Ex-vivo, programmed mobilized peripheral blood (mPB) cells
Control Arm
Untreated mobilized peripheral blood (mPB) cells

Locations

Country Name City State
United States University of Alabama Birmingham Alabama
United States Dana Farber Cancer Institute Boston Massachusetts
United States University of Chicago Chicago Illinois
United States Jewish Hospital Cincinnati Ohio
United States The Ohio State University Columbus Ohio
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States City of Hope Duarte California
United States Indiana Blood and Marrow Transplant Indianapolis Indiana
United States Sarah Cannon Research Institute Nashville Tennessee
United States Weill Cornell Medicine New York New York
United States Oregon Health & Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Huntsman Cancer Institute (University of Utah) Salt Lake City Utah
United States Texas Transplant Institute San Antonio Texas
United States University of California, San Diego (UCSD) Moores Cancer Center San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Cumulative Incidence of Grade II to IV aGvHD Through Day +100 Based on Investigator Assessment Acute GvHD (aGvHD) is assessed by assigning the clinical stage for the target organs (skin, liver, and gut) along with assigning an overall grade based on the minimum degree of organ involvement required to confer that grade. Grade II is defined as Stage 1 skin, Stage 1 liver, or Stage 1 GI; Grade III is defined as any Stage 1-3 skin, and Stage 2-3 liver, or Stage 2-4 GI; Grade IV is defined as Stage 4 skin, or Stage 4 liver and any Stage GI. A higher overall grade indicates a more severe outcome. The cumulative incidence of CIBMTR Grade II to IV aGVHD through approximately 100 days following HCT is measured by the percentage of participants who experienced grade II to IV aGVHD. The cumulative incidence and the associated 95% confidence interval are estimated using a competing risk analysis with death and relapse without grade II-IV aGvHD as a competing risk. 100 days post-HCT
Secondary 1-year GvHD-free, Relapse-free Survival (GRFS) 1-year GvHD-free, relapse-free survival (GRFS) is a composite endpoint in which events included Grade III to IV aGvHD, cGvHD requiring systemic immunosuppressive therapy, relapse, or death from any cause. GRFS is defined as the time from HCT to the earlier of the dates of the first documented CIBMTR Grade III-IV aGvHD, first use of systemic immunosuppressive therapy for cGvHD, first documented relapse of the underlying malignancy, or death from any cause. Subjects who are alive with no documented events for Grade III-IV aGvHD, use of systemic immunosuppressive therapy for cGvHD, relapse, or death at the data cutoff will be censored at their last visit date or follow-up on or prior to the date of one-year study completion/early discontinuation. The Kaplan-Meier estimate of the median GRFS and the 95% CI are presented 365 days post-HCT
Secondary Percentage of Subjects Alive Without Relapse and Without Moderate or Severe cGvHD at Day +365 - mITT Population Percentage of subjects alive without relapse and without moderate or severe cGvHD per NIH Consensus Criteria at Day +365 365 days post-HCT
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT04460235 - Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma Phase 4
Completed NCT04022785 - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Phase 1
Completed NCT03678493 - A Study of FMT in Patients With AML Allo HSCT in Recipients Phase 2
Recruiting NCT05424562 - A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
Completed NCT03197714 - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia Phase 1
Terminated NCT03224819 - Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML) Early Phase 1
Active, not recruiting NCT04070768 - Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Active, not recruiting NCT04107727 - Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) Phase 2
Recruiting NCT04385290 - Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC) Phase 1/Phase 2
Recruiting NCT04920500 - Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients N/A
Recruiting NCT03897127 - Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics Phase 3
Active, not recruiting NCT04021368 - RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Phase 1
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Completed NCT02485535 - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant Phase 1
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Recruiting NCT04069208 - IA14 Induction in Young Acute Myeloid Leukemia Phase 2
Recruiting NCT05744739 - Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2