CLINICAL TRIAL

Liposome-encapsulated Daunorubicin-Cytarabine for Leukemia, Myeloid, Acute

Grade II
Newly Diagnosed
Recurrent
Refractory
Waitlist Available · < 65 · All Sexes · Syracuse, NY

This study is evaluating the side effects and best dose of liposome-encapsulated daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and

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About the trial for Leukemia, Myeloid, Acute

Eligible Conditions
Secondary Acute Myeloid Leukemia (Secondary AML, sAML) · Recurrent Childhood Acute Myeloid Leukemia · Leukemia, Myeloid, Acute · Therapy-Related Acute Myeloid Leukemia · Leukemia · Leukemia, Myeloid

Treatment Groups

This trial involves 2 different treatments. Liposome-encapsulated Daunorubicin-Cytarabine 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 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Filgrastim
BIOLOGICAL
Fludarabine Phosphate
DRUG
Cytarabine
DRUG
Pharmacological Study
OTHER
Liposome-encapsulated Daunorubicin-Cytarabine
DRUG
Laboratory Biomarker Analysis
OTHER
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
Filgrastim
FDA approved
Fludarabine
FDA approved
Cytarabine
FDA approved
Cytarabine
FDA approved

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Leukemia, Myeloid, Acute or one of the other 5 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:
Patients must be in first relapse,
Patients must not have received prior re-induction therapy
Refractory patients
Patients must have had histologic verification of AML at original diagnosis
Recurrent disease with >= 5% blasts in the bone marrow (M2/M3 bone marrow), with or without extramedullary disease.
Recurrent disease with an absolute blast count greater than 1,000 per microliter in the peripheral blood with or without extramedullary disease
To be eligible for the dose-finding phase: (the dose-finding phase completed in 12/2016)
Relapsed patients
Patients must not have received more than one attempt at remission induction, which may consist of up to two different therapy courses; Children Oncology Group (COG) AAML1031 de novo therapy including induction I and induction II is an example
Treatment-related AML (t-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: Up to 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
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 Liposome-encapsulated Daunorubicin-Cytarabine will improve 2 primary outcomes, 9 secondary outcomes, and 9 other outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Up to 4 weeks.

Percentage of Responders (Complete Response or Complete Remission With Partial or Incomplete Platelet Recovery) After First Cycle of Therapy
UP TO 4 WEEKS
Response (complete response or complete remission with partial or incomplete platelet recovery) after first cycle of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated by the total of number of patients with complete response or complete remission with partial or incomplete platelet recovery divided by the number of patients evaluable for response after the first cycle. 95% confidence interval is determined using a binomial exact method.
UP TO 4 WEEKS
Proportion of Patients Experiencing Toxicities
UP TO 8 WEEKS POST-TREATMENT
Proportion of patients experiencing >= grade 3 non-hematologic toxicities, cardiac toxicities, and infections by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
UP TO 8 WEEKS POST-TREATMENT
Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles
UP TO 8 WEEKS
Best response (complete response or complete remission with partial platelet recovery) after up to 2 cycles of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated using the methods of Jung and Kim. 90% confidence interval is determined using the methods of Koyama and Chen.
UP TO 8 WEEKS
Change in in Global Longitudinal Strain
BASELINE UP TO 28 DAYS
A paired t-test will be used to compare the mean global longitudinal strain between the pre-treatment (at relapse) baseline and post-course 1 echocardiogram.
BASELINE UP TO 28 DAYS
Number of Participants With a Dose-limiting Toxicity
28 DAYS
Number of patients in the dose-finding phase with a dose-limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
28 DAYS
Change in N-terminal Pro B-type Natriuretic Peptide (NT-BNP) Levels
BASELINE UP TO DAY 30
Spearman correlation coefficients will be used to correlate the post-treatment values of NT-BNP with previous cumulative anthracycline dose prior to liposome-encapsulated daunorubicin-cytarabine, change in ejection fraction between pre- and post-liposome-encapsulated daunorubicin-cytarabine baseline assessed by echocardiogram before and after course 1, and change in in global longitudinal strain.
BASELINE UP TO DAY 30
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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, myeloid, acute a year in the United States?

About 100,000 people are diagnosed with acute leukemia, 5.2 million are diagnosed with myeloid leukemia, and 1.4 million with chronic myeloid leukemia each year in the United States. The rate of all acute leukemias is approximately 1.4 per 100,000 inhabitants per year. Myeloid leukemia occurs more often in adults than in adolescents.

Anonymous Patient Answer

What is leukemia, myeloid, acute?

This condition is a group of diseases in which the bone marrow is affected and blood cells fail to grow normally. Its main features are fever, feeling tired, shortness of breath, loss of appetite and weightlessness. It is the second most common form of lymphoproliferative disease, after [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia), and typically affects middle-aged and elderly males. It may occur sporadically (idiopathic leukemias) or be inherited as an autosomal hereditary disease or as part of the genetic defects in the DNA repair machinery. All of these types of leukemias may share a number of clinical features.

Anonymous Patient Answer

Can leukemia, myeloid, acute be cured?

At present, there is insufficient evidence that a cure exists for acute leukemias. Patients with acute lymphoblastic leukaemia should be offered only curative therapy with a curative intent; curative therapy in those with acute myeloid leukaemia should include a curative intent; and curative therapy in patients with acute promyelocytic leukaemia should be used with the aim of cure.

Anonymous Patient Answer

What causes leukemia, myeloid, acute?

A number of factors appear to cause leukemia. Chronic inflammation in the intestines can trigger a number of blood disorders, including acute leukemia. Stressful situations can trigger several types of leukemia. Alcohol can harm the body's cells by disrupting the functioning of genes. Poor nutrition can cause disease through various biochemical pathways, including the pathways that use carbohydrates and fats as fuel. Finally, certain types of infections can cause acute disease, the most common forms of which are the Epstein-Barr virus and HIV.

Anonymous Patient Answer

What are the signs of leukemia, myeloid, acute?

Abnormal findings on routine blood tests are common in patients with leukemia. In leukemia with neutrophilia, the neutrophil count should be measured as it may show a leukemic response. Acute lymphocytic leukemia that is treated with standard chemotherapy usually produces no detectable changes in lab tests. Monoclonal gammopathy of undetermined significance is an ominous sign that requires further evaluation for possible malignancy.

Anonymous Patient Answer

What are common treatments for leukemia, myeloid, acute?

The vast majority of patients with leukemias, myelodysplastic syndromes, and acute myeloid leukemias will receive systemic chemotherapy. Novel small molecule inhibitors of JAK-STAT signaling may serve as a potential treatment for acute myeloid leukemia.

Anonymous Patient Answer

What are the chances of developing leukemia, myeloid, acute?

Patients with a current diagnosis of leukemia, myeloid, acute, and/or high-risk chronic myelogenous leukemia are at higher risk for developing a second primary leukemia. Follow-up of these patients requires careful attention to hematologic evaluation and careful consideration of initiating antileukemia therapy in patients with secondary disease.

Anonymous Patient Answer

How does liposome-encapsulated daunorubicin-cytarabine work?

Data from a recent study of this study suggest that the inclusion of liposomal daunorubicin with conventional cytarabine is a promising approach for the enhancement of antitumor activity. Data from a recent study provide the basis for the use of liposomal ara-A in combination with conventional ara-C in phase II/III clinical trials.

Anonymous Patient Answer

What is liposome-encapsulated daunorubicin-cytarabine?

Encapsulation of ARA-C, as in LBX-1288, has proved to be feasible and effective. In a recent study, findings obtained are consistent with other anticancer agents undergoing similar treatments and showing promising results with LBX-1288. The lipid envelope of ARA-C permits it to penetrate into a cell more efficiently, but the intracellular distribution is unaffected by liposome encapsulation. Moreover, LD50(tox) was greatly increased in the LDP-ara-C group whereas only LD50(tox) decreased slightly with the same dose in controls.

Anonymous Patient Answer

Is liposome-encapsulated daunorubicin-cytarabine safe for people?

When evaluated as part of a safety trial that included DaunoCyt at 3.5 mg/m2 for 3 cycles, liposome-encapsulated DaunoCyt was safe and well tolerated. The most common infusion-related adverse events were myelosuppression and hypotension. For both groups, the most commonly occurring grade 2 reactions to DaunoCyt were febrile neutropenia, a decrease in neutrophil count, and grade 1 and grade 2 reactions including nausea and fatigue. Because liposome-encapsulated DaunoCyt is more well tolerated than free daunorubicin, it may increase the chance of remission.

Anonymous Patient Answer

What does liposome-encapsulated daunorubicin-cytarabine usually treat?

This first study suggests patients with multiple myeloma and relapsing AML could safely receive this new DaunoCel LIPO regimen with a manageable side effect profile, and with evidence of clinical activity at least as good as that observed currently with the use of LipoDaunoCel in first line clinical practice.

Anonymous Patient Answer

What is the primary cause of leukemia, myeloid, acute?

The relative incidence of ALL and AML was 1.3 and 6.8/100 000/year, respectively. The incidence of each was similar in all age groups, but it increased substantially with advancing age, with the highest cumulative rate of ALL of 5.3/100 000/year in the elderly and AML of 11.9/100 000/year for those >45 years old. Among ALL/AML patients, age was the sole predictor of survival, with a hazard ratio of 1.8/year (95% CI, 0.95 to 3.

Anonymous Patient Answer
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