CLINICAL TRIAL

gene-modified T cells targeted for Leukemia

1 Prior Treatment
Recurrent
Refractory
Waitlist Available · 18+ · All Sexes · New York, NY

This study is evaluating whether modified T cells can be safely given to patients with ALL.

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About the trial for Leukemia

Eligible Conditions
Leukemia, Lymphoid · Precursor Cell Lymphoblastic Leukemia-Lymphoma · Acute Lymphoblastic Leukemia (ALL) · Leukemia

Treatment Groups

This trial involves 2 different treatments. Gene-modified T Cells Targeted is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
gene-modified T cells targeted
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
This means that patients must have a form of leukemia that does not respond to treatment, has come back after being treated, can be detected in the blood even when it is in remission, or is in the first round of treatment. show original
Complete remission means the restoration of normal blood cell production, with a white blood cell count greater than 1,000,000, a platelet count greater than 100,000, and a hemoglobin level greater than 10 show original
MRD is defined as a patient having residual disease, as measured by a quantitative PCR, flow cytometry, or deep-sequencing of the IgH rearrangements show original
Creatinine levels must be less than 2.0 mg/100 ml, bilirubin levels must be less than 2.0 mg/100 ml, AST and ALT levels must be less than 3x the normal level, PT and PTT levels must be less than 2x the normal level, with the exception of patients who are receiving stable chronic anticoagulation therapy show original
The subject must have adequate cardiac function, as assessed by a recent Echo or MUGA scan. show original
The person has adequate pulmonary function if their oxygen saturation is 92% or more when measured on room air. show original
Patients who have leukemia must have cells that have CD19+ on them show original
Patients aged 18 and over are eligible for the study. show original
Relapsed B-ALL will be defined as patients that meet the above criteria for a CR before developing recurrent disease (increased bone marrow blasts). Refractory patients will be defined as patients that have not achieved a CR after 1 cycle of induction chemotherapy
Patients who have leukemia must have a diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether gene-modified T cells targeted will improve 1 primary outcome and 1 secondary outcome in patients with Leukemia. Measurement will happen over the course of 2 years.

To assess the anti-leukemic effect of adoptively transferred anti-CD19 T cells.
2 YEARS
2 YEARS
To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL.
2 YEARS
2 YEARS

Patient Q & A Section

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

What are the signs of leukemia?

While some of the signs of leukemia are similar to those of multiple sclerosis, there are more specific signs of leukemia. Patients with leukemia may have an increased risk of developing multiple sclerosis. There are also signs to look for when considering whether a patient has leukemia.

Anonymous Patient Answer

Can leukemia be cured?

There is an urgent need for new and better therapies for leukemias. Clinical and translational researches will be important to further evaluate the role of HDACi administration in leukemia therapy.

Anonymous Patient Answer

What causes leukemia?

Causes of leukemias include genetic and environmental carcinogens, viral infections and hematopoietic stem cell defects. Leukemias may arise from mutations in genes for cytokines or cell surface receptors. Radiation therapy and chemotherapy may also play a role in acute leukemia and chronic leukemia, respectively.\n

Anonymous Patient Answer

What is leukemia?

There are 3 types of blood cancers: myeloid leukemia, lymphoid leukemia, and acute leukemia/b-cell lymphoma. Leukemia can have a debilitating effect on patients and occasionally lead to very early deaths. Lymphoma is a group of cancers, including various subtypes of B-, T- and NK- cell lymphomas. The most common form is Non-Hodgkin's lymphoma, as it is also the most common type of leukemia in the United States.

Anonymous Patient Answer

What are common treatments for leukemia?

Patients with leukemia receive various therapies. There is no cure, but the goals of treatment are to stop cancer growth and reduce the risk of recurrent cancer growth.

Anonymous Patient Answer

How many people get leukemia a year in the United States?

A high prevalence of acute and chronic lymphoid leukemia is observed, making the incidence of both extremely low. The incidence of CLL is lower and the incidence of AML is higher than in Europe and in the Japanese population. In AML, the number of people diagnosed with this disease decreases from the southern part of the country to the northern part, in accordance with a high incidence of AML on the north-eastern part of the U.S. It is possible that lifestyle changes and the ageing of the population may be linked with low CLL incidence in the northern portion of the country.

Anonymous Patient Answer

Does gene-modified t cells targeted improve quality of life for those with leukemia?

Immune cell therapy is an effective treatment for patients with metastatic leukemia. Gene-modified T cells redirected to leukemia cells will improve quality of life, and increase the chance to survive cancer.

Anonymous Patient Answer

Have there been other clinical trials involving gene-modified t cells targeted?

The use of CD19-targeted gene-modified T cells can represent an important avenue of further evaluation of gene-modified T cells targeting B cells. Results from a recent clinical trial has been helpful for the future design and application of these cells as therapeutic agents. Nevertheless, the CD19-targeted T-cell therapy and the immune functions of T cells remain major aspects of treatment for allogeneic stem cell transplantation (allo-SCT). It would be critical to determine, in the future, if CD19-targeted gene-modified T cells provide significant benefits in combating the malignancies for which allograft transplantation has been used for many years.

Anonymous Patient Answer

How does gene-modified t cells targeted work?

Results from a recent clinical trial establishes that CAR-T cells targeting CD19 are a promising therapy in vitro. It is hoped that a gene therapy approach will improve both the safety and efficacy that can be realized in human clinical applications.

Anonymous Patient Answer

What is the latest research for leukemia?

A lot happens every week and it is hard to keep up with the latest research. I am so busy with a lot of other studies that I could not find information about leukemia for this article. So please ask your doctor. If the latest research is important, take it to your doctor.

Anonymous Patient Answer

What is the survival rate for leukemia?

Survival rate for newly diagnosed patients with AML has declined in New England/New Jersey from 1974-2005 whereas survival was similar in the rest of the country. More than 70% of patients with newly diagnosed AML were eligible for allogeneic or autologous bone marrow transplantation. In this cohort, a 1-year event-free survival of >45% existed and in spite of higher rates of relapse or progression in more recent years. This suggests a shift in treatment from induction chemotherapy with anthracycline, and then transplantation to high-dose regimen therapy with autologous and allogeneic transplantation for newly diagnosed patients with AML.

Anonymous Patient Answer

Is gene-modified t cells targeted safe for people?

Gene-modified T cells represent an exciting treatment tool for cancer that is available for use in humans. There are many barriers to their use including risk, cost, and the need for repeated injections. The clinical significance of the use of gene-modified T cells is a contentious issue. Data from a recent study from this phase I study suggest that these cell types may be safe and can be safely administered peripherally when combined with a common, well tolerated chemotherapy.

Anonymous Patient Answer
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