CLINICAL TRIAL

KITE-222 for Leukemia

Recruiting · 18+ · All Sexes · Cleveland, OH

This study is evaluating whether a new drug can be used to treat people with acute myeloid leukemia.

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About the trial for Leukemia

Eligible Conditions
Leukemia, Myeloid · Acute Myeloid Leukemia (AML) · Leukemia, Myeloid, Acute · Leukemia

Treatment Groups

This trial involves 2 different treatments. KITE-222 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.
Fludarabine
DRUG
KITE-222
BIOLOGICAL
Cyclophosphamide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed 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:
is associated with a significantly better overall survival than performance status of 2 or 3 show original
Relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML)
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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: First infusion date of KITE-222 up to 15 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: First infusion date of KITE-222 up to 15 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 KITE-222 will improve 1 primary outcome and 17 secondary outcomes in patients with Leukemia. Measurement will happen over the course of First infusion date of KITE-222 up to 28 days.

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
FIRST INFUSION DATE OF KITE-222 UP TO 28 DAYS
DLTs are defined as KITE-222-related events with an onset within the first 28 days after the KITE-222 infusion
30 Day All-cause Mortality Rate
FIRST INFUSION DATE OF KITE-222 UP TO 30 DAYS
The mortality rate is calculated by number of deaths, regardless of cause, within 30 days from the KITE-222 infusion date divided by the total number of participants included in the safety analysis set. The safety analysis set consists of all participants treated with any dose of KITE-222.
60 Day All-cause Mortality Rate
FIRST INFUSION DATE OF KITE-222 UP TO 60 DAYS
The mortality rate is calculated by number of deaths, regardless of cause, within 60 days from the KITE-222 infusion date divided by the total number of participants included in the safety analysis set. The safety analysis set consists of all participants treated with any dose of KITE-222.
Pharmacodynamics (PD): Peak Plasma of Key Analytes (Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector Molecules) in Participants With r/r AML Treated with KITE-222
ENROLLMENT (BEFORE LEUKAPHERESIS) AND DAYS -5 & 0 (PREDOSE) AND DAYS 1-13 EVERY OTHER DAY,14,21, WEEK 4, POST-TREATMENT FOLLOW-UP (MONTH 2 AND AT RELAPSE FOR PARTICIPANTS WITHOUT ALLO-SCT OR AT RELAPSE FOR PARTICIPANTS WITH ALLO-SCT)
PD Parameter: AUC of Key Analytes (Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector Molecules) in Participants With r/r AML Treated with KITE-222
ENROLLMENT (BEFORE LEUKAPHERESIS) AND DAYS -5 & 0 (PREDOSE) AND DAYS 1-13 EVERY OTHER DAY,14,21, WEEK 4, POST-TREATMENT FOLLOW-UP (MONTH 2 AND AT RELAPSE FOR PARTICIPANTS WITHOUT ALLO-SCT OR AT RELAPSE FOR PARTICIPANTS WITH ALLO-SCT)
AUC is defined as the area under the concentration versus time curve.
PK Parameter: AUC of KITE-222 CAR T Cells in Participants With r/r AML Treated with KITE-222
ENROLLMENT (BEFORE LEUKAPHERESIS) AND D0 (PREDOSE), D3,7,10,14 &21, W4, PTFU (W6, M2,3,6,9,12,15,18 &24 AND AT RELAPSE FOR PARTICIPANTS WITHOUT ALLO-SCT OR WITHIN 1 W BEFORE CC, D-1 OF ALLO-SCT, M1,3,6,12 &24 AND AT RELAPSE FOR PARTICIPANTS WITH ALLO-SCT
AUC is defined as the area under the concentration versus time curve. PK will be assessed at enrollment (before start of leukapheresis) and Day 0 (predose) and on Days 3, 7, 10, 14 & 21, Week 4, post-treatment follow-up (Week 6, Months 2, 3, 6, 9, 12, 15, 18, & 24 and at relapse for participants without allo-SCT or within 1 week before conditioning chemotherapy and Day -1 of allo-SCT, Months 1, 3, 6,12 & 24 and at relapse for participants with allo-SCT). CC=conditioning chemotherapy D=Day(s) M=Month PTFU= post-treatment follow-up W=Week
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Patient Q & A Section

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

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

Over 300 newly diagnosed cases of acute leukemia are diagnosed in the United States, excluding people already in remission, every year. Chronic leukemias, a serious form of leukemia, occur in approximately 70,000 people in the United States, and about 9,000 people die from them each year. Chronic leukemia is the second-most common cancer in American adults, but is often overlooked by doctors and patients. The high number of people with leukemia may result from high exposure to cancer-causing drugs, exposure to a variety of other environmental agents, or genetic mutations that increase the malignant risk of leukemia. New treatment options could be useful for patients with chronic leukemia because it is difficult and expensive to treat such patients with existing agents.

Anonymous Patient Answer

What are common treatments for leukemia?

Treatment for leukemia varies; however, most patients are treated with chemotherapy, bone marrow transplantation, and/or radiation. Hematopoietic stem cell transplantation may also be considered as a therapy in select cases.

Anonymous Patient Answer

Can leukemia be cured?

Although one of the first diseases successfully treated with leukemic therapies, leukemia has a cure rate of less than 30%. Current treatments are relatively benign and prolong life by 2 – 4 months. Lifespan would be increased substantially with clinical remission.

Anonymous Patient Answer

What is the survival rate for leukemia?

While the survival rate with all types of leukemia is low, the average survival rate for ALL has been steadily improving, with some cases surviving well into adulthood with current treatments. Patients suffering from AML are now living longer than they were a decade ago, although many still die quickly, especially during and after chemotherapy. Treatments are still being developed to try and improve survival and keep patients more in touch with their health-care providers as they deal with their disease.

Anonymous Patient Answer

What are the common side effects of kite-222?

Findings from a recent study shows that the majority of patients treated with Kite-222 experienced some sort of side effect. Side effects were more common during the first 7 weeks of treatment. Most side effects were transient and resolved with drug cessation. Some patients were asymptomatic while others experienced headache, rash, and a slight decrease in liver function. Some side effects may be dose related. A careful monitoring of patients receiving Kite-222 is imperative for early detection.

Anonymous Patient Answer

Is kite-222 safe for people?

Treatment is well tolerated, but caution is needed when considering concurrent use of bortezomib or cytarabine. Dose adjustment of kite-222 is recommended in people with severe hepatic impairment or in patients receiving concurrent bortezomib or cytarabine therapy.

Anonymous Patient Answer

Is kite-222 typically used in combination with any other treatments?

These data suggest that the addition of ARA-C to kite-222 is more effective in prolonging response and survival than the use of kite-222 alone in the treatment of HL in the elderly. A prospective comparative study is necessary to confirm these observations.

Anonymous Patient Answer

What are the latest developments in kite-222 for therapeutic use?

This report of the latest developments in kite-222 for therapeutic use provides the most recent information and confirms that our initial experiments with Kite-222 in human clinical trials are consistent with our animal models in that it shows clinical activity in a variety of cancers including: melanoma, solid tumors of the colon, breast, and liver. Results from a recent paper also suggest Kite-222 may have advantages to existing chemotherapeutic agents.

Anonymous Patient Answer

Have there been other clinical trials involving kite-222?

The clinical profile suggests a favorable safety profile for patients undergoing treatment with kite-222. However, in this pilot study no data on the impact of kite-222 on the natural history of cancer and disease progression was collected. Additional studies with longer protocols are warranted.

Anonymous Patient Answer

What are the signs of leukemia?

An important initial symptom is pallor of the face and upper torso. Other signs include anemia, a low white cell count, and fever. A high level of calcium in the blood indicates the seriousness of the disease and the need for immediate treatment.

Anonymous Patient Answer

What causes leukemia?

Although there are many leukemias of unknown origin, they also result from a combination of genetics and exposure to ionizing radiation. Chronic lymphocytic leukemia may have a genetic basis. There is also evidence that exposure to ionizing radiation increases the risk of developing chronic myelogenous leukemia.

Anonymous Patient Answer

What is leukemia?

Leukemia is a type of blood cancer that forms in white blood cells. It is typically associated with white blood cells that have abnormally high numbers of white blood cells. Most often the first symptom of leukemia is feeling tired. Leukemia is typically identified through a blood test to observe abnormal blood cells in the bloodstream and bone marrow. It is diagnosed through biopsy of affected tissues. Leukemia is treated surgically and sometimes with chemotherapy and radiation therapy. Survival is typically related to the type of leukemia. Over the past few decades much information has been learned about cancer and the treatment of a new cancer has gotten progressively better. The survival rate for childhood leukemia has improved by nearly 80% since the 1970s.

Anonymous Patient Answer
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