FT516 for Acute Myeloid Leukemia (AML)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Phoenix, AZ
Acute Myeloid Leukemia (AML)+6 More
FT516 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called FT516 may help treat certain types of leukemia and lymphoma.

See full description

Eligible Conditions

  • Acute Myeloid Leukemia (AML)
  • B-cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acute Myeloid Leukemia (AML)

Study Objectives

This trial is evaluating whether FT516 will improve 2 primary outcomes and 5 secondary outcomes in patients with Acute Myeloid Leukemia (AML). Measurement will happen over the course of Day 29.

Day 57
FT516 pharmacokinetic data
Cycle 2 Day 29
Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
Objective response rate (ORR) of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
Day 29
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
Up to 5 years
Incidence and nature of AEs of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
Severity of AEs of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.

Trial Safety

Safety Progress

1 of 3

Other trials for Acute Myeloid Leukemia (AML)

Trial Design

4 Treatment Groups

FT516 in Combination with Monoclonal Antibodies
1 of 4
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
1 of 4
FT516 in Combination with Monoclonal Antibodies following Bendamustine Condition...
1 of 4
FT516 Monotherapy
1 of 4
Experimental Treatment

This trial requires 234 total participants across 4 different treatment groups

This trial involves 4 different treatments. FT516 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

FT516 in Combination with Monoclonal AntibodiesFT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing ScheduleFT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
FT516 in Combination with Monoclonal Antibodies following Bendamustine ConditioningBendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
FT516 MonotherapyFT516 monotherapy in adult subjects with r/r AML.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
IL-2
2007
Completed Phase 4
~1130
FT516
Not yet FDA approved
Cyclophosphamide
FDA approved
Rituximab
FDA approved
Bendamustine
2008
Completed Phase 3
~2660
Obinutuzumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Mayo Clinic - Phoenix, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Acute Myeloid Leukemia (AML) or one of the other 6 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Primary Refractory AML
Relapsed AML defined as not in CR after 1 or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required
Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival.
Provision of signed and dated informed consent form (ICF)
Age ≥18 years old
Stated willingness to comply with study procedures and duration
Presence of measurable disease
KEY

Patient Q&A Section

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

"This estimate is for all AML, CML, and PLL. It does not estimate ALL and CLL separately. The age-adjusted AML risk [the number of new cases per million people aged 15 and older in a given year] is 1.6 (95% confidence interval (1.5-1.7)) and varies with age, gender and race.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"Signs of acute leukemia include fever, fatigue, and a decreased appetite. Other symptoms of leukemia may be present, such as diarrhea or constipation, itching, a feeling of general malaise, or a skin rash. Chronic leukemias present as chronic unexplained fever without other specific symptoms. It may also be possible to see these signs on the skin before other symptoms appear." - Anonymous Online Contributor

Unverified Answer

What causes leukemia?

"A combination of genetic, environmental and random chance factors are mostly responsible for leukemia. Hereditary disorders (not specifically acute leukemia or leukemia) are usually not the main cause of leukaemia. Those conditions with other genetic syndromes may be the trigger for the development of the disease. Those with chronic leukaemia usually also have other conditions that contribute to their disease. These secondary conditions can be very serious and are likely to be one of the principal reasons why the patient ends up hospitalized or dies. It is impossible to know for sure all of the factors that contribute to leukemia." - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"A cancer causing a large number of white blood cells. In general it describes a symptom or a lab parameter. 'Leukemia' specifically refers to a type of cancer cell type. There are several leukemias involving specific cell types such as AML, B lymphoma, and T lymphoma among others." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"Many of the treatments that are currently utilized are also used in the treatment of the most common type of cancer, leukemia. This leads to a need for treatment guidelines in the area of leukemia." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"Chronic myeloid leukemias may respond to chemotherapy but the response is partial. Early stage acute lymphocytic leukemias respond well to induction chemotherapy with a 50% 5-year survival. The response to maintenance or consolidation chemotherapy is unpredictable. The response rate to induction chemotherapy may vary from 3% to 85% depending on the clinical sub-type of the disease at time of diagnosis. The majority of acute lymphocytic leukemias have a dismal prognosis. Chronic or acute myeloid leukemias have not yet been cured and have a mean survival time of 4-5 months." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia?

"Patients with acute myeloid leukemia who are not interested in immediate disease-free survival benefit most from clinical trial participation. People with CML may not find clinical trial participation justified depending on their anticipated survival time. If a clinical trial would improve chances of survivorship in patients who seem to be candidates, they should consider it." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ft516 for therapeutic use?

"This report describes two important new aspects of ft516: a novel mechanism of action, and selective inhibition of the protein kinase B2, or Akt. These data are consistent with the hypothesis that the efficacy of ft516 is mediated by its ability to inhibit PI3K/Akt/mTOR signalling. Pharmacological validation of ft516 inhibition of this signalling pathway is essential for further refinement, but we expect that the combination of these two features will yield a clinically useful inhibitor." - Anonymous Online Contributor

Unverified Answer

How does ft516 work?

"Results from a recent clinical trial show that treatment with ft516 dramatically improves survival and slows progression in mice bearing human B-cell leukemia xenografts. Specifically, treatment with ft516 significantly increased the number of mice that remain in remission as well as the time to tumor relapse, providing support for the idea that ft516 may be an effective treatment for B-cell disease." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia?

"The average age of diagnosis of leukemia in children (≤ 19 years) is 10.5 years compared to that of lymphoematosis (≤ 17.4 years). The age-adjusted incidence of ALL peaked around 10 years in this study and has declined slightly beyond it; the peak of incidence in children (≤ 19 years) was between 1990 and 1995. The decline was also seen in childhood ALL and childhood T-ALL. As childhood ALL started in 1991, this might have some impact on future risk estimation/prediction. Childhood ALL incidence was around 4.4 and 2.5 for boys and girls, respectively. Although our research did not mention it, the childhood ALL incidence in the 1990s was less than 10." - Anonymous Online Contributor

Unverified Answer

Has ft516 proven to be more effective than a placebo?

"ft516 demonstrated efficacy for the treatment of patients with chronic leukemia, and the results of this study may help to guide further studies of ft516 in chronic-phase patients." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for leukemia?

"Survival of patients with CLL (chronic lymphocytic leukemia) depends upon the type of disease present, the age of the patient, and the characteristics of the individual patient. Survival varies not only between those who have the disease for a year or two vs. those who have the disease for 10 or 20 yr, but also within each category according to each specific cancer." - Anonymous Online Contributor

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