Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Graft vs Host Disease

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloproliferative Disorders

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Homologous Wasting Disease

Acute Graft Versus Host Disease

Lymphosarcoma

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Etoposide phosphate

Busulfan

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.

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.

Ex-vivo, programmed mobilized peripheral blood (mPB) cells

ProTmune

Untreated mobilized peripheral blood (mPB) cells

Control Arm

Sarah Cooley, MD

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.

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

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

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.

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

Percentage of subjects alive without relapse and without moderate or severe cGvHD per NIH Consensus Criteria at Day +365

Fate Therapeutics

Non-serious AEs were reported by the investigator from Day -10 through Day +365 post-HCT. All SAEs were reported by the investigator from Day -10 through +365; only those SAEs considered by the investigator to be related to investigational product/study procedure were reported up to Day +730 post-HCT. All-cause mortality and AE reporting are based on the safety population, defined as all subjects who received investigational product.

Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells.

Safety population includes all subjects who received IP. Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization.

All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all Phase 1 subjects who received ProTmune ex vivo programmed mPB cells.

Phase I ProTmune

Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells.

Safety population includes all subjects who received IP (ProTmune or Control). Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization.

All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all subjects in the randomized treatment group, regardless of actual treatment received.

Phase 2 ProTmune

Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells.

Safety population includes all subjects who received IP (ProTmune or Control). Subjects in the treatment group represent the actual treatment received, regardless of the treatment the subject was allocated to receive at randomization.

All-cause mortality includes measure of all deaths, due to any cause, that occurred during the study in the Intent-to-treat (ITT) population, defined as all subjects in the randomized treatment group, regardless of actual treatment received.

ProTmune: Ex-vivo, programmed mobilized peripheral blood (mPB) cells

Control Arm: Untreated mobilized peripheral blood (mPB) cells

Phase 2 Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

For Phase 2, one participant in each group (ProTmune and Control) diagnosis date was not available.

Time from initial diagnosis of primary disease (months)

Executive Director, Clinical Operations

Subjects with an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who received 1 unit of ProTmune ex vivo programmed mPB cells.

Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of ProTmune ex vivo programmed mPB cells.

Subjects with an available 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated peripheral blood cell donor who were randomized to received 1 unit of unmanipulated mPB cells.

Modified intent-to-treat (mITT) population

* Phase 1: All subjects who received ProTmune
* Phase 2: All randomized subjects who received Investigational Product (ProTmune or Control mPB units)

Spots Global Cancer Trial Database for Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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