Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Mantle-Cell

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Mantle Cell Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Carfilzomib given in four doses, days 1, 2, 15 and 16, every 28 days for 6 months starting within 6 months post ASCT. Doses given in an escalated phase 1 design, starting at 20/20 mg/m2, later increased to 20/27 mg/m2, 20/36 mg/m2 and 20/45 mg/m2. CFZ dose based on actual body surface area at baseline (cycle 1). Patients with a body surface area (BSA) greater than 2.2 m2 receive dose based upon a 2.2 m2 BSA. Adjustments are not made if weight gains or losses are less than or equal to 20% from baseline. Dexamethasone 4 mg by vein or mouth prior to each CFZ dose in cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, then it should be restarted and administered prior to subsequent doses for reactions.

Starting dose: 20/20 mg/m2 by vein on Days 1, 2, 15, and 16 of each 28 day cycle.

Carfilzomib

4 mg by vein or mouth prior to each Carfilzomib dose in Cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, it should be restarted and administered prior to subsequent doses for reactions.

Issa F. Khouri, MD,BS

The goal of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given to patients with lymphoma after a stem cell transplant. The safety of this drug will also be studied.

Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.

Study Groups:

If you agree to take part in this study, you will be assigned to a dose level of carfilzomib based on when you joined this study. Up to 4 dose levels of carfilzomib will be tested. Three (3) participants will be enrolled at each dose level until the highest tolerable dose level is found. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. When the highest tolerable dose is found, more participants may be enrolled at that dose level.

Study Treatment:

Each study cycle is 28 days.

On Days 1, 2, 15, and 16 of each cycle, you will receive carfilzomib by vein over 30 minutes. You will receive hydration by vein before and after each infusion of carfilzomib in Cycle 1. This may be repeated in Cycle 2, if your doctor thinks it is needed. On these days during Cycles 1 and 2, before you receive carfilzomib you will receive dexamethasone by vein or as a tablet by mouth. Dexamethasone may help prevent possible infusion reactions. You may continue to receive dexamethasone before each dose of each cycle depending how well you tolerate the infusion.

You will be monitored closely for at least 1 hour for possible infusion reactions after each dose during Cycle 1 and on Day 1 of Cycle 2. If you have an infusion reaction, your doctor may delay or stop the infusion, and you may receive drugs to help relieve the symptoms.

You will have about 12 days of "rest" between each cycle of treatment (during this time you will not receive carfilzomib).

Study Visits:

On Day 1 (+ or - 3 days) of Cycle 1 and on Day 1 of all other cycles, women who are able to become pregnant will have blood (about 1 teaspoon) drawn for a pregnancy test. To take part in this study, you must not be pregnant.

About 1 day before you receive carfilzomib in each cycle:

* You will have a physical exam including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will be asked about how you are feeling and about any side effects you may be having.

About 1 day and about 15 days before you receive carfilzomib in each cycle, blood (about 2 tablespoons) will be drawn for routine tests and to check your kidney and liver function.

At any point that your doctor thinks they are needed, you will have a bone marrow aspiration and computed tomography (CT) and/or positron emission tomography (PET) scans to check the status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

End-of-Treatment Visit:

Within 30 days of your last dose of study drug, you will return to the clinic. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about how you are feeling and about any side effects you may be having.
* Blood (about 4 tablespoons) will be drawn for routine tests and to check the status of the disease.

During follow-up, the study staff may also contact you and your local doctor by telephone to ask about your health.

Length of Study:

You may remain in this study for about 2 years from the time of first dose. You may receive up to 6 cycles of treatment during this time, which will take about 7 months to complete. You will be taken off study early if the disease gets worse, you cannot keep appointments, you miss more than 2 doses of carfilzomib in a row, if intolerable side effects occur, or if you decide that you want to leave the study early.

This is an investigational study. Carfilzomib is FDA approved and commercially available for the treatment of multiple myeloma. The use of carfilzomib to treat lymphoma after a stem cell transplant is investigational.

Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Carfilzomib Consolidation Therapy After Autologous Stem Cell Transplantation (ASCT) for Mantle Cell Lymphoma (MCL), T-cell Lymphoma (TCL), and Diffuse Large B-Cell Lymphoma (DLBCL)

Carfilzomib Consolidation Therapy After Autologous Stem Cell Transplantation (ASCT) for Patients With Mantle Cell (MCL), T-cell (TCL), and Diffuse B-Cell Lymphoma (DLBCL)

Maximum tolerated dose (MTD) defined as dose with a posterior probability of treatment-related dose-limiting toxicity (DLT) during the first 56 days closest to the target of 30%. DLT defined as: equal or greater than Grade (G) 2 neuropathy with pain, equal or greater than G3 non-hematologic toxicity, G4 neutropenia greater than 7 days, febrile neutropenia, G4 thrombocytopenia lasting for more than 7 days despite withholding CFZ, G3/4 thrombocytopenia with bleeding, or equal or greater than Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal by day 56.

Efficacy assessed by progression free survival (PFS) and overall survival (OS) at 2 years. Assess progression rate and correlations with Ki67, and gene profiling. Distributions of PFS and OS estimated by Kaplan-Meier method, and distributions compared between groups by using the log-rank test. Cox proportional hazards regression models will be fit to assess the relationship between baseline covariates of interest and these survival parameters.

Amgen

M.D. Anderson Cancer Center

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Cicatrix

Hematologic Neoplasms

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Leukemia-Lymphoma, Adult T-Cell

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Adult T-cell Leukemia/lymphoma

Spinocerebellar Ataxia Autosomal Recessive 7

Universal CD7-specific CAR gene-engineered T cells

Lung-Ji Chang, Ph.D

Ying Deng

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.

Hematological malignancies including B-, T-cell acute lymphoblastic leukemia (B-ALL, T-ALL), B and T cell lymphoma (BCL, TCL), natural killer cell lymphoma (NKL) and acute myeloid leukemia (AML) are aggressive diseases which may express the early T cell development molecule CD7.T-ALL represents 15% of childhood and 25% of adult ALL, and T-ALL patients are prone to early disease relapse and suffer from poor treatment outcomes. According to European Group for the Immunological Characterization of Leukemias (EGIL), the presence of cytoplasmic or membrane expression of CD3 defines T-ALL. Several immunophenotypic classifications have been proposed: (TI) the immature subgroup or pro-T-ALL is defined by the expression of CD7 and cCD3; (TII) pre-T-ALL also expresses CD2 and/or CD5 and/or CD8; (TIII) or cortical T-ALL shows CD1a positivity; and (TIV), mature T-ALL is characterized by the presence of surface CD3 and CD1a negativity.Over the past few years, T cells modified with lentiviral chimeric antigen receptor (CAR) gene have been studied in different clinical settings. CD7 is a T cell surface molecule that plays important role in T cell and B cell interaction in early lymphoid development, displays membrane expression early during T cell development before TCR rearrangement, and persists through terminal stages of T cell development, and has been a well-known marker for T-ALL. CD7 is considered a promising target for the treatment of T-ALL, TCL, AML and NKL. In this study, the study proposes to investigate an universal CD7 targeting CAR-T design, 4SCAR7U in combination with alternative targeting CAR-T cells as a new strategy to treat CD7-positive hematological malignancies.

The 4SCAR7U T cells are genetically engineered and manufactured in bulk amount that can be supplied off-the-shelf without being custom made from individual patients. The immediate availability of the CAR-T cells makes clinical treatment convenient and timely for rapid progressing disease or for highly immune suppressed patients. This application can be time- and cost-effective. This novel approach may also overcome problems of functionally defective autologous T cells. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of the 4SCAR7U T cell product in hematological malignancies. Another goal of the study is to learn more about the function of this novel product and its persistence in the patients.

Universal 4SCAR7U Targeting CD7-positive Malignancies

Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies

Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Shenzhen Geno-Immune Medical Institute

Multiple CAR T cells to treat CD7-positive hematological malignancies

CD7-specific CAR gene-engineered T cells

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cell therapy against CD7-positive hematological malignancies using CD7 specific CAR T cells. The study also aims to learn more about the function of CD7 CAR T cells and their persistence in patients of hematological malignancies.

Hematological malignancies including T-cell acute lymphoblastic leukemia (T-ALL), T cell lymphoma (TCL), natural killer cell lymphoma (NKL) and acute myeloid leukemia (AML) are aggressive diseases which may express the early T cell development molecule CD7.

T-ALL represents 15% of childhood and 25% of adult ALL, and T-ALL patients are prone to early disease relapse and suffer from poor outcomes. Several immunophenotypic classifications have been proposed. According to European Group for the Immunological Characterization of Leukemias (EGIL), the presence of cytoplasmic or membrane expression of CD3 defines T-ALL. Four subgroups are proposed: (TI) the immature subgroup or pro-T-ALL is defined by the expression of CD7 and cCD3; (TII) pre-T-ALL also expresses CD2 and/or CD5 and/or CD8; (TIII) or cortical T-ALL shows CD1a positivity; (TIV) finally, mature T-ALL is characterized by the presence of surface CD3 and CD1a negativity.

Over the past few years, T cells modified with lentiviral chimeric antigen receptor (CAR) gene have been studied in different clinical settings. CD7 is a T cell surface protein that plays important role in T cell-B cell interaction in early lymphoid development, displays membrane expression early during T cell development before TCR rearrangement, and persists through terminal stages of T cell development, and a well-known marker for T-ALL. CD7 is considered a promising target for the treatment of T-ALL, TCL, AML and NKL. In this study, we will investigate CD7 CAR-T in combination with alternative targeting CAR-T cells as a new strategy to treat hematological malignancies.

The T cells from patients or transplantation donors will be genetically modified with lentiviral CAR vector to recognize CD7 expressed on the surface of the cancer cells. The engineered T cells will be applied to patients through intravenous delivery.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple CAR-T cell therapy in hematological malignancies. Another goal of the study is to learn more about the function of CAR T cells and their persistence in the patients.

Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies

A Multi-Center Study of Multiple CAR T Cell Therapy for CD7-positive Hematological Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carfilzomib Consolidation Therapy After Autologous Stem Cell Transplantation (ASCT) for Mantle Cell Lymphoma (MCL), T-cell Lymphoma (TCL), and Diffuse Large B-Cell Lymphoma (DLBCL)	NCT01926665	Lymphoma	Carfilzomib Dexamethasone	18 Years - 70 Years	M.D. Anderson Cancer Center
Universal 4SCAR7U Targeting CD7-positive Malignancies	NCT05995028	T-cell Acute Ly... T-cell Acute Ly... Acute Myeloid L... NK Cell Lymphom...	Universal CD7-s...	6 Months - 75 Years	Shenzhen Geno-Immune Medical Institute
Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies	NCT04033302	T-cell Acute Ly... T-cell Acute Ly... Acute Myeloid L... NK Cell Lymphom...	CD7-specific CA...	6 Months - 75 Years	Shenzhen Geno-Immune Medical Institute

Spots Global Cancer Trial Database for tcl

Every month we try and update this database with for tcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tcl

Every month we try and update this database with for tcl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.