Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Rituximab

Melphalan

Thymoglobulin

Thiotepa

Antilymphocyte Serum

Infusion of CD19-specific T cells derived from cord blood (CB) 42 days following stem cell transplantation.

Starting dose level of T-cells not to exceed 106/m2.

The investigational component of the treatment plan of this study is the infusion of CD19-specific T cells derived from cord blood (CB) to be infused Day +42 to Day +100 following stem cell transplantation. The transplant component of the treatment plan will include CB transplant regimens that are commonly use for CB transplantation.

Single UCB unit arm does not start enrollment until Dose Level A2 in the double UCB unit arm has been deemed safe.

Infusion of CD19-specific T cells derived from cord blood (CB) 42 days following stem cell transplantation.

Starting dose level of T-cells not to exceed 106/m2.

The investigational component of the treatment plan of this study is the infusion of CD19-specific T cells derived from cord blood (CB) to be infused Day +42 to Day +100 following stem cell transplantation. The transplant component of the treatment plan will include CB transplant regimens that are commonly use for CB transplantation

Infusion of CD19-specific T cells derived from cord blood (CB) 42 days following stem cell transplantation.

T-Cell Infusion

Cord Blood Infusion

Elizabeth Shpall, MD

The goal of this clinical research study is to learn if an infusion of white blood cells (called T cells) that have been genetically changed is safe to give patients who have received an umbilical cord blood transplant (UCBT). Researchers want to learn if these genetically changed T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia after they have received an UCBT, how long the changed T-cells stay in the body, and if adding them to standard transplant could improve how patients respond to treatment.

Funding Source - FDA OOPD

T-cell infusion:

The gene transfer used in this study involves umbilical cord blood cells taken either from your UCB unit(s) or from cells left over after your UCB unit has been processed. Researchers perform a gene transfer to change the T-cells' DNA (the genetic material of cells), and then inject the changed T-cells into the body of the patient receiving the transplant. This process is called a modified donor lymphocyte infusion (DLI) or T-cell infusion.

Chemotherapy and UCBT:

After the umbilical cord blood unit has been identified for your transplant and after it has arrived at the hospital, you will be admitted to the hospital to receive chemotherapy and the UCBT. These procedures are not considered part of this research study. You will discuss these procedures with a study doctor and sign an informed consent document with specific details of the UCBT procedure and possible risks, at another time.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

The T-cell Infusions:

After the UCBT, the study doctor will decide when you will be eligible for the T-cell infusions. You must be at least 42 days past your UCBT without any serious evidence of active graft versus host disease (GVHD). GVHD occurs when the donor cells attack the cells of the person receiving the transplant.

The T-cell infusion is given by vein, usually over 15-30 minutes over 2 days. A smaller dose of T cells will be infused on the first day and if this is tolerated the remaining dose of T cells will be infused within 72 hours after the first infusion. During both infusions, your vital signs will be checked.

Study Tests:

Within 30 days before the T-cell infusion:

* Blood (about 2 tablespoons) will be drawn to check how well the donated blood cells and tissue are mixing with your blood. Researchers use this test to find out how successful the transplant is. This is a standard test for patients who have received a transplant.
* Blood (about 2 tablespoons) will be drawn for research tests to measure the number of B-cells and other (non-transplanted) T-cells.

Within 7 days before the T-cell infusion:

* You will have a physical exam.
* You will be checked for possible reactions to your UCBT, including GVHD and graft failure.
* Blood (about 4 tablespoons) will be drawn for routine tests, to check your immune system, and to check for HAMA immune system reactions.

Within 24 hours, and then about 3 days, 1 week (+/- 2 days), 2 weeks (+/- 2 days), 4 weeks (+/- 7 days), 8 weeks (+/- 7 days), 3 months (+/- 7 days), 6 months (+/- 7 days), and 12 months (+/- 7 days) after the T-cell infusion:

* You will have a physical exam.
* You will be checked for possible reactions to your treatment, including GVHD and graft failure.
* Blood (about 4 tablespoons) will be drawn for routine tests.

About 1 month (+/- 7 days), 2 months (+/- 7 days), 3 months (+/- 7 days), 6 months (+/- 7 days), and 12 months (+/- 7 days) after the T-cell infusion, blood (about 2 tablespoons) will be drawn to check certain protein levels. This may be checked more often, and the protein may be replaced, if your doctor thinks it is needed.

Once during Weeks 2 and 4, and then once a month for 6 months after the T-cell infusion, blood (about 1 teaspoon) will be drawn to check your immune system. This blood draw may be done at the same time as the blood draws for routine tests when possible, to avoid extra "needle sticks".

After the 2nd T-cell infusion:

* Blood (about 2 tablespoons) will be drawn for research tests to check the level of the infused T-cells and to measure the number of B-cells and other (non-transplanted) T-cells.

About 30 days and 3, 6, and 12 months after the T-cell infusion:

* You will have a physical exam, and you will be checked for possible reactions to your treatment, including GVHD and graft failure.
* Blood (about 2 tablespoons) will be drawn for research tests to check the level of the infused T-cells and to measure the number of B-cells and other (non-transplanted) T-cells. °During the Month 3 visit, part of this blood sample will be used to check for HAMA immune system reactions.
* Urine will be collected for routine tests.
* You will have a bone marrow aspiration and biopsy performed to check the status of the disease.
* If you have lymphoma, you may have a you will have a positron emission tomography - computed tomography (PET-CT) scan and/or a CT scan of your neck, chest, abdomen, and pelvis to check the status of the disease, if your doctor thinks it is needed.

Tests and/or procedures may be repeated more often, if your study doctor thinks it is needed.

Length of Study:

You may continue taking part in this study for up to 12 months. You will be taken off study if the disease gets worse, you have any infections, intolerable side effects occur, you are not able to follow study directions, the T-cells do not engraft (grow in your body), or you are not able to receive a T-cell infusion.

You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, or if your transplant doctor decides it is needed.

Your participation on this study will be over once you have completed the planned study visits at 12 months after the last T-cell infusion.

Long-Term Follow-Up:

For safety reasons, the U.S. Food and Drug Administration (FDA) requires that patients who receive infusions of stem cells treated with a gene transfer procedure must have long-term follow-up for at least 15 years after receiving the gene transfer. You will be asked to sign a separate consent form for a long-term follow-up study named Protocol 2006-0676.

This is an investigational study. The gene transfer (or T-cell infusion with genetically changed T cells) is not commercially available or FDA approved for use in this type of disease. Gene transfer in this study is considered investigational.

Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.

Infusion of Allogeneic Umbilical Cord Blood-Derived Cluster of Differentiation Antigen 19 (CD19)-Specific T Cells

Donor-Derived, CD19-Specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies After Umbilical Cord Blood Transplantation

MTD is highest dose level in which 6 participants treated with at most 2 experiencing dose-limiting toxicity (DLT) using Common Toxicity Criteria (CTC) following the t-cell infusion Day 42 to Day 100.

Secondary graft failure determined by dose-limiting toxicity (DLT) if probably or definitely related to the infused T cells within 30 days of infusion.

M.D. Anderson Cancer Center

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Amino Acids

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Immunomodulating Agents

Immunoglobulins

Ibrutinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.

Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.

Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).

Julio Chavez, M.D.

The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.

Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction

Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.

Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.

Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x10\^9/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL.

Merck Sharp & Dohme LLC

Janssen Scientific Affairs, LLC

H. Lee Moffitt Cancer Center and Research Institute

Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.

Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.

Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).

Pembrolizumab and Ibrutinib

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Julio Chavez, MD, MS

CR/PR

Stable Disease

Overall Response Rate (ORR) to the Therapeutic Intervention

Time to Best Response

Progression-free Survival (PFS)

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hematinics

Liver Extracts

Participants who are in good health and without history of cancer disease

Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases.

Luca Mazzarella, MD

This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood.

Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.

The goal of this study is the evaluation of a new instrument called See.d, to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection).

Blood samples collected from healthy volunteers will be spiked-in with reference DNA and mock-CTC to mimic a patient sample in order to evaluate the instrument performance through the analysis of several parameters.

Blood samples from Metastatic Breast Cancer (MBC) patients will be processed with See.d instrument installed in a clinical context to perform a preliminary analytical characterization of either cell-free DNA (cfDNA) and Circulating Tumor Cells (CTC).

For its feasibility nature, no formal statistics has been planned for this study.

Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications

This is a preliminary research study without an IPD information sharing plan

Evaluation of total adhered cell count on SBS slides

Evaluation of the area of adhered cell nuclei on SBS slides

Evaluation of the ratio between cfDNA and genomic contaminant DNA

Recovery of putative Circulating Tumor Cells (CTCs)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Infusion of Allogeneic Umbilical Cord Blood-Derived Cluster of Differentiation Antigen 19 (CD19)-Specific T Cells	NCT01362452	Leukemia Lymphoma	T-Cell Infusion Cord Blood Infu...	1 Year - 75 Years	M.D. Anderson Cancer Center
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia	NCT03514017	Chronic Lymphoc...	Pembrolizumab Ibrutinib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications	NCT06097156	Healthy Partici... Breast Cancer		18 Years -	Tethis S.p.A.

Spots Global Cancer Trial Database for white blood cells