Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Leukemia

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Graft vs Host Disease

Hematologic Diseases

Lymphosarcoma

Homologous Wasting Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Busulfan

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.

Starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.

Dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.

Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.

Amin Alousi, MD

The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.

The Study Drugs:

Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die.

Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. It is also designed to suppress the immune system and help prevent GVHD.

Study Drug Administration and Transplant:

If you are an inpatient, on Day -8 (8 days before the date of transplant), you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour.

If you are an outpatient, on Day -30 through Day -8, you will receive a low-level test dose of busulfan through a needle in your vein over 1 hour each day.

You will be given an anti-seizure drug to help prevent seizures each time you receive busulfan. Your doctor will explain how the drug will be given and the drug's risks. Seizures are a rare but serious side effect of busulfan.

On Days -8, -6, and -4, blood (about 1 teaspoon each time) will then be drawn a total of 11 times for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. This PK testing will be done to find the dose of busulfan needed for your body size on the other days that you receive busulfan.

On Day -6 through Day -3, you will receive your body-specific dose of busulfan by vein over 3 hours each day. If you cannot have the blood level tests performed for any reason, you will receive the standard busulfan dose. You will receive fludarabine through a needle in your vein over 1 hour on each of these days before you receive busulfan.

On Day 0, you will receive the donor bone marrow or blood stem cells by vein over about 1 hour.

On Day +3 and Day +4, you will receive cyclophosphamide by vein over 3 hours.

On Days +3 thru +5 just before the first dose of cyclophosphamide and then every 4 hours, you will receive mesna by vein over 30 minutes for a total of 10 doses. Mesna is a drug that protects bladder cells from damage by chemotherapy drugs. It is used to decrease the risk of bleeding in the bladder.

Once a day starting on Day +7, you will receive filgrastim (G-CSF -- a drug that helps with the growth of white blood cells) through a needle under your skin until your blood cell levels reach "recovered" levels for 3 days in a row.

Study Visits:

Every day you are in the hospital and at each outpatient visit, you will have a physical exam to check for symptoms of GVHD.

Blood (about 3 teaspoons) will be drawn at least 2 times a week for the first 100 days after the transplant for routine tests.

About 1 month after your transplant, then once every 3 months up to a year, the following tests and procedures will be performed:

* Blood (about 5 tablespoons) will be drawn for routine tests and to check for CMV. Blood draws may be repeated more often, if you doctor thinks it is needed.
* Urine will be collected for routine tests.
* You will have a bone marrow aspirate and biopsy to check the status of the disease.

At Months 1, 2, 3, 6, and 12 after your transplant, blood (about 4 tablespoons) will be drawn to check the status of your immune system.

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

Length of Study:

You will be on study in the hospital for about 4 weeks. You will be taken off study if the disease gets worse or if the study doctor thinks it is in your best interest.

Long-Term Follow-Up:

After the first 24 months, you will receive either a phone call or a letter from the study doctor or your regular doctor 1 time each year to check the status of the disease. If you are contacted by mail, you will be given a self-addressed stamped envelope with which you can return your responses to the doctor.

This is an investigational study. Busulfan is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). Cyclophosphamide is FDA approved and commercially available for the treatment of lymphoma. The use of these drugs together for the possible prevention of GVHD is investigational.

Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.

Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.

Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.

Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.

Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.

Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.

Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.

Overall Survival (OS) is defined as the interval between day of transplant and day of death.

M.D. Anderson Cancer Center

Busulfan + Fludarabine + Cyclophosphamide

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Amin M. Alousi, MD/Stem Cell Transplantation

Cumulative Incidence of Grade II to IV Acute GVHD

Cumulative Incidence of Grade III to IV Acute GVHD

Day-100 Treatment-Related Mortality

Rate of Engraftment

2-year Progression-Free Survival

2-year Overall Survival

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Gemcitabine

Endothelial Growth Factors

Mitogens

Pancrelipase

Monatide (IMS 3015)

Pancreatin

Adjuvants, Immunologic

HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.

VEGFR1-A24-1084 (SYGVLLWEI)

Naohide Yamashita, MD, PhD

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.

HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

HLA-A\*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.

These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer

Human Genome Center, Institute of Medical Science, University of Tokyo

Tokyo University

Naohide Yamashita MD, PhD

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m\^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the safety and efficacy of this type of peptide.

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m\^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the feasibility and efficacy of this type of peptide.

HLA-A*02:01-restricted VEGFR1-derived peptide vaccination

Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted the study to confirm the safety and efficacy of combined modality intervention using conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000 mg/m\^2 (body surface area) will be administered on day 1, day 8, day 15, day 29, day 36, and day 43, respectively.

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).

HLA-A\*02:01-restricted VEGFR1-specific cytotoxic T lymphocyte (CTL) responses were obtained from HLA-A2/Kd transgenic murine model.

HLA-A\*02:01-restricted VEGFR1-specific CTL clones were also obtained from peripheral blood mononuclear cells of healthy volunteer donors.

These CTL clones showed potent anti-tumor CTL responses in HLA class Ⅰ-restricted manner in vitro.

Vaccination of HLA-A\*02:01-restricted VEGFR1-specific peptide to A2/Kd transgenic mice markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.

Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Phase I/II Trial of Human Leukocyte Antigen (HLA)-A*02:01-restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Conventional Dose of Gemcitabine for Advanced Pancreatic Cancer

Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)

Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.

Naohide Yamashita MD,PhD

Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events

HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area

Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine

Age, Categorical

Age Continuous

Early termination leading to small numbers of subjects analyzed

Hitomi Nagayama, M.D., Ph.D. / Project Lecturer

Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events

Number of Participants With Tumor Regression

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Carcinoma

Adenocarcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Dermatologic Agents

Coal Tar

HLA genotyping and tumor tissue profiling for certain TAA and LOH.

Tumor and HLA Profiling

Marlyane Motta, BS

OncoBay Clinical CRO

Justin Moser, MD

Jialing Zhang

Michael Hurwitz, MD

Brian Pico, MD

Marialby Donis Ramos

Jose Lutzky, MD

Melinda Porter

Sajeve Thomas, MD

Ben Orem

Jaspreet Grewal, MD

Marie Ventimiglia

Ira Winer, MD

Manar Al-Assi

Elizabeth Shelton, MPH

Brian Henick, MD

UNC Immunotherapy Team

Jared Weiss, MD

Cancer Answer Line

James Isaacs, MD

Rom Leidner, MD

Shelly Evans

Yazan Samhouri, MD

Barb Stadterman

Jason Luke, MD

Dawn Pinchasik, MD

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.

Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, subjects will provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 8 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than 8 months, a fresh tumor biopsy will be required at the time of the second visit.

If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.

A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors

Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumors

To identify subjects with Head and Neck, Cervical, Ovarian, Melanoma, Non-Small Cell Lung HPV positive anogenital and other types of cancers that could potentially be eligible for the TScan Therapeutics clinical trials.

TScan Therapeutics, Inc.

Symptoms and General Pathology

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Anti-Inflammatory Agents

Antiemetics

Antibodies

Dexamethasone

Dexamethasone acetate

Immunoglobulins

Ofatumumab

First dose of 300 mg Ofatumumab followed by seven weekly infusions of 2000 mg. Dexamethasone will be given orally at doses of 40 mg on days 1-4 in weeks 1, 3, 5, and 7. Maintenance therapy consists of 6 monthly infusions of 1000 mg ofatumumab.

Study treatment comprises eight weeks of induction therapy with ofatumumab in combination with high-dose dexamethasone. The first dose of ofatumumab is 300 mg followed by seven infusions of 2000 mg ofatumumab. Dexamethasone will be given orally at doses of 40 mg on days 1-4 in weeks 1, 3, 5, and 7. Patients who achieved a CR, PR shall proceed to maintenance therapy. Maintenance therapy consists of 6 monthly infusions of 1000 mg ofatumumab.

An HLA-matched sibling donor or HLA-matched unrelated donor can be identified for approximately 70% of patients. Donor search will be completed within six weeks for 95% of the patients. Patients with a donor will proceed to allogeneic HCT as soon as possible prior to, or during maintenance therapy.

Johannes Schetelig, PD Dr. med.

To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of allogeneic HCT in CLL

The goal of the study is to investigate the safety and efficacy of a consequent anti-CD20 therapy with the antibody ofatumumab in the context of allogeneic HCT. Allogeneic HCT itself is not a study intervention and is triggered by the availability of an HLA-compatible stem cell donor. The study is divided into an induction part and a maintenance part. During induction where the antibody is combined with high dose dexamethasone, the main goal is to reduce the tumor load prior to allogeneic HCT. Patients who achieved disease control (CR, PR and SD) by the antibody proceed to maintenance therapy with the antibody. Patients with progressive disease go off study. The idea behind maintenance therapy is that ofatumumab may contribute to tumor control early after allogeneic stem cell transplantation while T-cell based graft-versus leukemia effects are still not fully established. External tumor control could lower the pressure to taper immunosuppressive drugs early after transplantation and could thereby indirectly contribute to better GVHD-prophylaxis. Furthermore, anti-CD20 antibodies have proven activity in the treatment of chronic GVHD. In summary, the concept of a consequent CD20 blockade in the context of allogeneic transplantation could result in better leukemic control and better GVHD prophylaxis, which is a highly attractive goal.

Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation

Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation(CLL-X4 Trial)

efficacy analysis of anti-CD20 blockade with ofatumumab

rate of MRD-negative patients who did not experience relapse, progression or death within the first 14 months after study enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	NCT00800839	Hematologic Dis... Leukemia Lymphoma Myeloma	Busulfan Fludarabine Cyclophosphamid...	6 Months - 75 Years	M.D. Anderson Cancer Center
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer	NCT00683358	Pancreatic Canc... Pancreas Neopla...	VEGFR1-A24-1084...	20 Years - 85 Years	Tokyo University
Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer	NCT00683085	Pancreatic Canc... Pancreas Neopla...	HLA-A*02:01-res...	20 Years - 85 Years	Tokyo University
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	NCT00800839	Hematologic Dis... Leukemia Lymphoma Myeloma	Busulfan Fludarabine Cyclophosphamid...	6 Months - 75 Years	M.D. Anderson Cancer Center
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors	NCT05812027	Head and Neck C... Cervical Cancer Non Small Cell ... Melanoma Ovarian Cancer HPV16 Related C...	Tumor and HLA P...	18 Years -	TScan Therapeutics, Inc.
Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation	NCT01809847	Chronic Lymphat...	Ofatumumab	56 Years -	Technische Universität Dresden
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide	NCT00800839	Hematologic Dis... Leukemia Lymphoma Myeloma	Busulfan Fludarabine Cyclophosphamid...	6 Months - 75 Years	M.D. Anderson Cancer Center
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors	NCT05812027	Head and Neck C... Cervical Cancer Non Small Cell ... Melanoma Ovarian Cancer HPV16 Related C...	Tumor and HLA P...	18 Years -	TScan Therapeutics, Inc.

Spots Global Cancer Trial Database for hla

Every month we try and update this database with for hla 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 hla

Every month we try and update this database with for hla 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 hla 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.