Imatinib Mesylate

Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Leukemia + 17 more
Treatment
35 FDA approvals
20 Active Studies for Imatinib Mesylate

What is Imatinib Mesylate

ImatinibThe Generic name of this drug
Treatment SummaryImatinib is a cancer-fighting medicine used to treat several types of cancer. It is sold under the brand names Gleevec and Glivec. Imatinib works by blocking certain enzymes, which prevents tumor growth. This is the first drug of its kind, as it specifically targets cancer cells instead of just any rapidly dividing cells.
Gleevecis the brand name
image of different drug pills on a surface
Imatinib Mesylate Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Gleevec
Imatinib
2001
64

Approved as Treatment by the FDA

Imatinib, also called Gleevec, is approved by the FDA for 35 uses including Myelodysplastic Syndromes (MDS) and Hypereosinophilic Syndrome .
Myelodysplastic Syndromes (MDS)
Hypereosinophilic Syndrome
Gastrointestinal Stromal Tumors
Gastrointestinal Stromal Tumors
Leukemia, Myeloid, Accelerated Phase
Hypereosinophilic Syndrome (HES)
FIP1L1-PDGFRα fusion kinase status unknown Chronic eosinophilic leukemia
Myeloproliferative Disorders (MPD)
Accelerated phase chronic myologenic leukemia
Chronic Myeloid Leukemia, Blast Crisis
newly diagnosed, chronic phase Chronic myeloid leukemia
Chronic Eosinophilic Leukemia (CEL)
Metastatic Gastrointestinal Stromal Tumor
Gastrointestinal Stromal Tumor (GIST)
recurrent Dermatofibrosarcoma protuberans
Precursor Cell Lymphoblastic Leukemia-Lymphoma
refractory, chronic phase Chronic myeloid leukemia
metastatic Dermatofibrosarcoma protuberans
unresectable Gastrointestinal stromal tumor
cKit mutational status unknown Aggressive systemic mastocytosis
FIP1L1-PDGFRα fusion kinase status unknown Hypereosinophilic syndrome
Systemic Mastocytosis, Aggressive (ASM)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Blast Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Gastrointestinal Stromal Tumors
Myelodysplastic Syndrome
Leukemia
Hypereosinophilic Syndrome
Eosinophilic leukemia
Dermatofibrosarcoma
Dermatofibrosarcoma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Mastocytosis, Systemic
Myeloproliferative Disorders

Effectiveness

How Imatinib Mesylate Affects PatientsImatinib is a medicine used to treat certain types of cancer. It works by blocking the activity of certain proteins (called tyrosine kinases) that help cancer cells grow and divide. Imatinib specifically targets a protein called BCR-ABL, which is involved in many processes that cause cancer cells to grow and spread. Normal cells are usually not affected by imatinib because they have other proteins that can take over the job of the blocked protein. But cancer cells rely heavily on BCR-ABL, so they are more likely to be impacted by imatinib.
How Imatinib Mesylate works in the bodyImatinib mesylate is a drug that stops cancer cells from growing and spreading. It does this by blocking a protein called BCR-ABL, which is found in higher amounts in cancer cells. Imatinib also targets the proteins that help cancer cells survive, such as PDGF and SCF, by blocking their activity. In lab tests, imatinib has been shown to stop the growth of cancer cells and even cause them to die.

When to interrupt dosage

The measure of Imatinib Mesylate is contingent upon the determined ailment, including Metastatic Gastrointestinal Stromal Tumor, Hypereosinophilic Syndrome (HES) and Desmoid Tumors. The amount of dosage is contingent upon the method of delivery specified in the table below.
Condition
Dosage
Administration
Dermatofibrosarcoma
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Leukemia, Myeloid, Accelerated Phase
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Eosinophilic leukemia
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Gastrointestinal Stromal Tumors
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Myeloproliferative Disorders
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Myelodysplastic Syndrome
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Blast Phase
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Precursor Cell Lymphoblastic Leukemia-Lymphoma
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Chordoma
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Precursor Cell Lymphoblastic Leukemia-Lymphoma
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Hypereosinophilic Syndrome
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Leukemia
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Gastrointestinal Stromal Tumors
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Gastrointestinal Stromal Tumors
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Dermatofibrosarcoma
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Hypereosinophilic Syndrome
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Mastocytosis, Systemic
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution
Metastatic Melanoma
, 100.0 mg, 400.0 mg, 50.0 mg, 80.0 mg/mL
, Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Tablet, coated, Solution - Oral, Solution

Warnings

Imatinib Mesylate Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Imatinib Mesylate.
Common Imatinib Mesylate Drug Interactions
Drug Name
Risk Level
Description
2-Methoxyethanol
Major
The risk or severity of adverse effects can be increased when Imatinib is combined with 2-Methoxyethanol.
9-(N-methyl-L-isoleucine)-cyclosporin A
Major
The risk or severity of adverse effects can be increased when Imatinib is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
Abetimus
Major
The risk or severity of adverse effects can be increased when Imatinib is combined with Abetimus.
Acteoside
Major
The risk or severity of adverse effects can be increased when Imatinib is combined with Acteoside.
Aldosterone
Major
The risk or severity of adverse effects can be increased when Imatinib is combined with Aldosterone.
Imatinib Mesylate Toxicity & Overdose RiskCommon side effects of taking Voltaren include swelling, nausea, vomiting, muscle cramps, joint pain, diarrhea, rash, tiredness, and stomach pain. In animal studies, long-term use has been connected to liver, kidney, and heart damage, as well as a weakened immune system. Additionally, animals developed cardiomyopathy (heart muscle disease), chronic kidney disease, and tumors in the preputial gland. Genotoxic effects have been observed in laboratory tests. Fertility was not affected in animal studies. It is important to be aware of potential toxicities in humans, such as liver toxicity, kidney damage, cardiac
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Imatinib Mesylate Novel Uses: Which Conditions Have a Clinical Trial Featuring Imatinib Mesylate?

A total of 290 active studies are presently examining the use of Imatinib Mesylate in treating Metastatic Melanoma, unresectable Gastrointestinal stromal tumor and Systemic Mastocytosis.
Condition
Clinical Trials
Trial Phases
Precursor Cell Lymphoblastic Leukemia-Lymphoma
22 Actively Recruiting
Phase 2, Phase 1
Myelodysplastic Syndrome
127 Actively Recruiting
Phase 1, Phase 2, Phase 3, Not Applicable, Phase 4
Mastocytosis, Systemic
0 Actively Recruiting
Chordoma
0 Actively Recruiting
Leukemia
0 Actively Recruiting
Leukemia, Myeloid, Accelerated Phase
0 Actively Recruiting
Blast Phase
0 Actively Recruiting
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
0 Actively Recruiting
Myeloproliferative Disorders
2 Actively Recruiting
Not Applicable, Phase 2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
0 Actively Recruiting
Metastatic Melanoma
0 Actively Recruiting
Dermatofibrosarcoma
6 Actively Recruiting
Phase 2, Phase 3, Phase 1
Gastrointestinal Stromal Tumors
3 Actively Recruiting
Phase 2, Phase 1
Eosinophilic leukemia
0 Actively Recruiting
Gastrointestinal Stromal Tumors
0 Actively Recruiting
Gastrointestinal Stromal Tumors
0 Actively Recruiting
Hypereosinophilic Syndrome
0 Actively Recruiting
Dermatofibrosarcoma
0 Actively Recruiting
Hypereosinophilic Syndrome
0 Actively Recruiting
Precursor Cell Lymphoblastic Leukemia-Lymphoma
0 Actively Recruiting

Imatinib Mesylate Reviews: What are patients saying about Imatinib Mesylate?

5Patient Review
7/23/2021
Imatinib Mesylate for Stromal Tumor of Stomach or Intestines
Glivec was really effective in preventing the cancer from recurring and spreading. I did experience some side effects, but overall it's a great drug that has helped me stay calm during this difficult time.
5Patient Review
4/1/2018
Imatinib Mesylate for Chronic Phase Chronic Myeloid Leukemia
The only thing I experienced were occasional skin itchings on my lower legs, which were hardly noticeable.
4Patient Review
7/28/2013
Imatinib Mesylate for Chronic Phase Chronic Myeloid Leukemia
I experienced fatigue, an increase in weight, and headaches.
3.7Patient Review
3/7/2022
Imatinib Mesylate for Chronic Phase Chronic Myeloid Leukemia
I was diagnosed with CML on March 4th, 2022 in Lusaka, Zambia. So far I've only experienced nausea, vomiting, and intense hip bone joint pain. It's been just three days of taking this medication and I feel much better already. Hoping for continued success with this treatment!
3.3Patient Review
11/11/2009
Imatinib Mesylate for Stromal Tumor of Stomach or Intestines
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Patient Q&A Section about imatinib mesylate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is imatinib mesylate used for?

"Imatinib mesylate is approved to treat acute lymphoblastic leukemia in adults and children who test positive for the Philadelphia chromosome. In adults, it is used for disease that has recurred or is resistant to treatment."

Answered by AI

Is imatinib a chemotherapy?

"Imatinib, which is marketed worldwide by Novartis as Gleevec and Glivec, is an oral chemotherapy medication used to treat cancer."

Answered by AI

Is imatinib mesylate the same as imatinib?

"The drug Imatinib Mesylate is known by the trade name Gleevec and the generic name STI-571. In some cases, doctors or other health care professionals may use the trade name when referring to the generic drug."

Answered by AI

How does imatinib mesylate work?

"Imatinib works by binding to the ATP binding site, locking it in a closed or self-inhibited conformation, and inhibiting the enzyme activity of the protein. This process results in "switching off" the downstream signaling pathways that promote leukemogenesis."

Answered by AI

Clinical Trials for Imatinib Mesylate

Image of OHSU Knight Cancer Institute in Portland, United States.

Fludarabine + Cytarabine + Idarubicin + Venetoclax for Acute Myeloid Leukemia

18 - 65
All Sexes
Portland, OR
This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.
Phase 2
Waitlist Available
OHSU Knight Cancer InstituteCurtis A Lachowiez
Image of Ohio State University Comprehensive Cancer Center in Columbus, United States.

TriCAR19.20.22 T Cells for Blood Cancers

18+
All Sexes
Columbus, OH
This phase I trial tests the safety, side effects and best dose of anti-CD19/20/22 chimeric antigen receptor (CAR) T cells (TriCAR19.20.22 T cells) and how well they work in treating patients with non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as CD19, CD20 and CD22, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving TriCAR19.20.22 T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory non-Hodgkin lymphoma, ALL and CLL.
Phase 1
Waitlist Available
Ohio State University Comprehensive Cancer CenterSumithira Vasu, MD
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CMV-MVA Triplex Vaccine for Cancer

18 - 75
All Sexes
Duarte, CA
This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and/or effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.
Phase 1
Waitlist Available
City of Hope Medical Center (+2 Sites)Ryotaro Nakamura
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Emapalumab for Graft-versus-Host Disease

18 - 75
All Sexes
Duarte, CA
This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \[peripheral blood stem cell\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.
Phase 1
Waitlist Available
City of Hope Medical CenterAmandeep Salhotra
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EPI-321 for Muscular Dystrophy

18 - 75
All Sexes
Atlanta, GA
The goal of this clinical trial is to learn how safe and tolerable EPI-321 is and whether there may be early signs it is working in male or female adult (18 to 75 years) participants with facioscapulohumeral muscular dystrophy (FSHD) Type 1 condition. The main questions it aims to answer are: How safe is EPI-321 and how well can people handle it over time? How does EPI-321 interact with its target and does it show early signs of working? Participants will receive a single dose of EPI-321 through a vein while being closely watched in a hospital and visit the clinic regularly for tests and checkups for about 5 years after getting EPI-321.
Phase 1 & 2
Recruiting
Rare Disease Research (+3 Sites)Epicrispr Biotechnologies, Inc.
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CAR T Cell Therapy for Acute Lymphoblastic Leukemia

< 65
All Sexes
Memphis, TN
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The main purpose of this study is to determine: * Evaluate different doses of fludarabine prior CAR T cell infusion * How your body processes fludarabine and cyclophosphamide, * How long the CAR T cells last in the body, * Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and * The side effects of this therapy.
Phase 2
Recruiting
St. Jude Children's Research HospitalAimee Talleur, MD
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CD45RA Depleted Stem Cell Addback for Leukemia

1 - 25
All Sexes
Philadelphia, PA
The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.
Phase 1 & 2
Recruiting
Children's Hospital of PhiladelphiaTimothy Olson, MD, PhD
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Vedolizumab + Cyclophosphamide + Tacrolimus for Graft-versus-Host Disease

18 - 80
All Sexes
Duarte, CA
This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.
Phase 2
Recruiting
City of Hope Medical CenterMonzr M. Al Malki
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OKN4395 + Pembrolizumab for Solid Tumors

18+
All Sexes
Beverly Hills, CA
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab. This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more patients completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 5 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 pancreatic adenocarcinoma (OKN4395 alone), Cohort 3 in non-small cell lung cancer (NSCLC), Cohort 4 in colorectal cancer, and Cohort 5 in head \& neck squamous cell carcinoma (HNSCC), with cohorts 3 to 5 in combination with pembrolizumab. The monotherapy expansion Cohort 1 will also be used to explore the effect of food on the levels of OKN4395 in the blood. Similarly, Cohort 2 will be used to explore the effect of gastric pH on the levels of OKN4395 in the blood. The overall study will enrol approximately 166 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 100 participants in Part 1b split: 40 on monotherapy and 60 on combination therapy. The study will be conducted in the US, Australia, UK and in the EU.
Phase 1
Recruiting
Precision NextGen Oncology and Research Center (+2 Sites)Precision For Medicine
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