mitoxantrone + etoposide + gemtuzumab ozogamicin for Leukemia, Myeloid, Acute

Phase-Based Estimates
1
Effectiveness
2
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
Leukemia, Myeloid, Acute+3 More
mitoxantrone + etoposide + gemtuzumab ozogamicin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Myeloid, Acute

Study Summary

This study is evaluating whether a combination of chemotherapy drugs may help individuals with acute myeloid leukemia.

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Eligible Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia
  • Leukemia, Myeloid
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether mitoxantrone + etoposide + gemtuzumab ozogamicin will improve 1 primary outcome and 4 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Up to six weeks.

Day 1
Cytogenetic Status
Day 1
Percent of blasts
Up to five years
Overall Survival (OS)
Progression-free Survival (PFS)
Up to six weeks
Complete Remission Rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
mitoxantrone + etoposide + gemtuzumab ozogamicin

This trial requires 53 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin 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 2 and have already been tested with other people.

mitoxantrone + etoposide + gemtuzumab ozogamicin
Drug
10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

UPMC Hillman Cancer Center - Pittsburgh, PA

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Able to understand and have the ability to provide written consent.
Age: ≥18 and ≤75 years-old
Patients with newly diagnosed AML based on the World Health Organization classification who have persistent disease after their first course treatment with an anthracycline and cytarabine (the diagnosis of persistent disease, which is defined as ≥10% blasts by morphology for this trial or >5% blasts if they have had an increase in blasts from the last bone marrow biopsy, will be based on their assessment after bone marrow aspiration and/or biopsy after initial treatment).
Patients with myelodysplastic syndrome (MDS) based on the World Health Organization classification who have persistent disease after their treatment with an anthracycline and cytarabine (the diagnosis of persistent disease, which is defined as ≥10% blasts by morphology for this trial or >5% blasts if they have had an increase in blasts from the last bone marrow biopsy, will be based on their assessment after bone marrow aspiration and/or biopsy after initial treatment).
The criterion is met by a patient who has a CD33-positive leukemic blast count in the bone marrow. show original
The trial was stopped early because the treatment group had a significantly higher rate of disease progression than the control group. show original
Calculated creatinine clearance ≥ 30 mL/min (using the Cockcroft-Gault equation CL creatinine = ((140-age) x body mass X 0.85 if female)/72 x creatinine where age is given in years, body mass is given in Kg and creatinine is given in mg/dl).
Aspartate aminotransferase (AST) ≤ 2.5 x upper normal limit.
Alanine aminotransferase (ALT) ≤ 2.5 x upper normal limit.
A patient is eligible for this criterion if he/she is 18 years or older and has a total bilirubin level of less than 2 x upper normal limit. show original

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 common treatments for leukemia, myeloid, acute?

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Common treatment for acute hemodialysis for chronic leukemia-related end stage kidney disease (CKD) is the anti-inflammatory, anabolic steroid, and angiotensin-converting enzyme inhibitor, amlodipine. Other common treatments include the anti-inflammatory, anabolic steroid, oral iron, and erythropoiesis stimulating agents (ESA'S).

Unverified Answer

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

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More than 1.6 million people in the US are diagnosed with leukemia, myeloid or acute each year. The prevalence ranges from 21 per 100 000 whites, to 33 per 100 000 blacks, to 55 per 100 000 Latinos. The average annual incidence in the United States is 1.2 per 100 000 whites.

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What are the signs of leukemia, myeloid, acute?

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Signs include fatigue, malaise, weight loss, fever, night sweats, and pale skin color. The main features of leukemia are bone marrow disease and white blood cell (WBC) elevation. The presence of anemia or thrombocytopenia on physical examination is indicative of myeloid, acute leukemia. Leukemic cells infiltrate bone marrow, can be found in blood, or present in the perivascular and periportal spaces.

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What causes leukemia, myeloid, acute?

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Leukemia, myeloid, acute is a fairly common complication of chemotherapy, and in some cases is a complication of other underlying health problems. Most individuals, however, are diagnosed with leukemia without any other predisposing factors. There is little, if any, support for the concept of a specific gene-environment interaction.

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What is leukemia, myeloid, acute?

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Leukemia affects approximately 1 in 300 people in the United States every year. Most leukemia cases are non-Hodgkin lymphoma and are in remission with or without radiation therapy. Most acute myeloid leukemia cases are non-B acute myeloid leukemia. Acute promyelocytic leukemia is the most common type of acute myeloid leukemia; all types of acute myeloid leukemia involve abnormal white blood cells. Acute leukemias without a genetic or unknown cause occur most often in adults under 45. Acute myeloid leukemia is the most common cause of death due to leukemia in the United States.

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Can leukemia, myeloid, acute be cured?

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Today, more favorable treatment results than those obtained in the 1960s are achievable. The cure rate now for acute leukemia, in the absence of remission induction, is about 40%. CCRTC is an important indicator for the ability to achieve a cure in acute myeloid leukemia. CCRTC is present in about 100% of all patients with this disease at the time of diagnosis and, more importantly, in 100% of patients with CCRTCs who achieve a complete response. In summary, patients who have had their CCRTCs removed will benefit much more from cure than those who still have them.

Unverified Answer

Is mitoxantrone + etoposide + gemtuzumab ozogamicin safe for people?

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Combination chemotherapy with the current standard of care including ABVD is well tolerated. A majority of patients tolerated the combination chemotherapy with no significant increase in toxicity and no significant decreases in efficacy. A phase III trial is planned to examine the safety and efficacy of mitoxantrone + etoposide + gemtuzumab ozogamicin in relapsed/refractory myeloid ALL.

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What is the survival rate for leukemia, myeloid, acute?

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[For patients with acute lymphoid leukemia, the 5-year survival rate was 66.4% while the 5-year survival rate for patients with acute myeloid leukemia was 64.4%. Because most people with leukemia receive new treatments, these statistics may be different from the current survival rates in the general population. For example, there is very good information for the survival rate for acute lymphoid leukemia, but very little information for acute myeloid leukemia|AML]] and for acute lymphoblastic leukemia]] (see "patients and diagnostic tests" section).

Unverified Answer

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

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The common type of leukemia (leukaemic) is usually the product of a mutation in a cell division gene. These abnormalities in gene function may result in a shortened life expectancy for the cell. The specific types of leukemia (myeloid, acute, and chronic) are generally due to inherited problems causing abnormal cell function.

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How quickly does leukemia, myeloid, acute spread?

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After a period of 2–3 years, patients develop the signs of leukemia, myeloid, acute. After 6 months of diagnosis, ALL was significantly more likely to present with signs of leukemia and myeloid, acute, but with a slightly longer time to diagnosis, MAL was still significantly more likely. If signs of leukemia and myeloid, acute, are seen early after leukemia, diagnosis is likely. However, if signs of leukemia and myeloid, acute, are found later, it is highly likely, but not certain, that ALL was not present after diagnosis.

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How serious can leukemia, myeloid, acute be?

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This is a first-time evaluation of the use of the World Health Organization staging system in an adult leukemia population to evaluate the prognostic implications of low to intermediate-1 IPFL for cancer outcomes. Although there is very limited evidence in this setting, the data suggest that in most cases a 5-year IPFL of <or=0.5 and an ISS>or =4 is associated with relatively long survivals for leukemia.

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