Cytarabine for Leukemia

Phase-Based Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Leukemia+7 More
Cytarabine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether venetoclax may be effective in combination with low-intensity chemotherapy for patients with acute lymphoblastic leukemia.

See full description

Eligible Conditions

  • Leukemia
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Lymphocytic, Acute, L1
  • Leukemia, Lymphoid
  • Recurrent T Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory T Acute Lymphoblastic Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Recurrent B Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cytarabine will improve 2 primary outcomes, 6 secondary outcomes, and 1 other outcome in patients with Leukemia. Measurement will happen over the course of From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 4 years.

Year 4
Overall survival (OS)
Year 4
Event-free survival (EFS)
Up to 28 days
DLT (Phase I)
Maximum tolerated dose (MTD) (Phase I)
Up to 4 years
Apoptotic protein expression and Bcl-2 dependency
Duration of response (DOR)
Incidence of adverse events
Minimal residual disease (MRD) negativity
Day 56
Overall response rate (Phase II)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Experimental (venetoclax, vincristine, cyclophosphamide)

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. 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.

Experimental (venetoclax, vincristine, cyclophosphamide)See Detailed Description.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Dexamethasone
FDA approved
Venetoclax
FDA approved
Cortisone
Not yet FDA approved
Methotrexate
FDA approved
Rituximab
FDA approved
Cyclophosphamide
FDA approved
Nelarabine
FDA approved
Asparaginase Escherichia coli
FDA approved
Vincristine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

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 7 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This means that the total serum bilirubin must be less than twice the upper limit of normal, unless the person has Gilbert's Syndrome, in which case the direct bilirubin must be less than twice the upper limit of normal. show original
An AST less than 3 times the upper limit of the normal range (ULN) is acceptable, except in cases of liver disease or hemolysis, in which case an AST less than 10 times the ULN is acceptable. show original
, unless they abstain from sexual activity altogether Females and males who are able to have children must use birth control for four months after the end of their treatment, unless they abstain from sexual activity show original
and then should be repeated every 4 weeks while on treatment For females of childbearing potential, a negative pregnancy test must be documented any time they are on treatment. show original
should be considered for allogeneic stem cell transplant (SCT) Patients with relapsed/refractory B- or T-cell ALL should be considered for allogeneic stem cell transplant (SCT) if they are fit enough to withstand the procedure. show original
The text states that the performance status of the patient is less than 3 on the ECOG Scale. show original
Alanine aminotransferase (ALT) is less than 3 times the upper limit of the normal range (ULN), unless the person has a disease that affects the liver or there is hemolysis, in which case an ALT level that is less than 10 times the ULN is acceptable. show original
Creatinine clearance is at least 30 mL/min. show original
Signed informed consent

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?

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Approximately 23,000 people get leukemia and AML in the United States each year. People with acute lymphocytic leukemia are at higher risk and are expected to recover more slowly. People with acute myeloid leukemia are at lower risk but have a worse prognosis, and people with chronic myelogenous leukemia have a better prognosis. The prognosis of adults who have been diagnosed with ALL, AML, or CML declines once the cancer has become chronic.

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Can leukemia be cured?

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Cure of leukemia could only be achieved when the cancerous genes are completely removed from the leukemia cells at the acute phase of the disease by employing high-dose therapy and intensive supportive care in addition to conventional consolidation therapies. However, the therapeutic efficacy is limited due to high rates of serious late treatment-related toxicities and the low rate of complete and long-term CR.

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What are common treatments for leukemia?

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There are dozens of possible drug targets for leukemias, and almost all of these could potentially be treated using drug therapy. However, several drugs have had their use curtailed due to intolerable side effects or unacceptably limited treatment benefits.

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What are the signs of leukemia?

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The signs of leukemia are diverse and depend both on what type of leukemia is present and the severity of the disease. Patients with AML experience symptoms that tend to be more severe than patients with ALL or CLL/SLL. All of these signs can be present without any specific underlying medical condition, especially in the setting of minimal residual disease, which often causes fever, night sweats, fatigue, an enlarged liver, and increased liver tests. In addition to the symptoms of fatigue, anemia, or other medical problems, most patients may also experience nausea, abdominal pain, or diarrhea because of malabsorption of key nutrients from the gastrointestinal tract.

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What causes leukemia?

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Leukemia can have multiple contributing causes, but exposure to certain chemicals or radiation during childhood or pregnancy are more likely. Leukemogenesis depends upon environmental exposures, as well as genetic factors. Leukemogenesis also involves many cell types in the immune system, such as myeloid cells, leukocytes, and lymphocytes. Leukemogenesis is more common in children, with most cases between ages 4 and 12, although it has been reported in neonates. Leukemogenesis is more common in males. leukemogenesis is a rare cancer with a worldwide occurrence.

Unverified Answer

What is leukemia?

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Cancer development can be due to an assortment of factors including environmental and inherited factors. Leukemogenesis is the process of creating cancer. The most common cause of leukemia is a mutation in the DNA nucleotides. A person's genetic makeups are inherited when they are born. Genetic causes can predispose a person to develop certain forms of cancer at certain ages. Leukemia does not arise from genes. When a single parent who has one child with leukemia does not have a specific chromosomal abnormalities that can cause leukemia, she or he does not have an increased risk of passing on cancer-causing mutations. Genetic causes of cancer only account for 5-10% of cases.

Unverified Answer

Has cyclophosphamide proven to be more effective than a placebo?

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Based on our results combined cyclophosphamide regimen and conventional therapy was superior to a placebo. Cyclophosphamide is a drug recommended as a possible treatment for AML in children. However, further randomized controlled studies are needed in order to confirm these results.

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Does leukemia run in families?

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A study in the UK has proven that there is a strong genetic link between myeloid and lymphoid leukaemia in some families. More research will be needed to establish how this genetic link causes the development of the disease.

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How quickly does leukemia spread?

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In North America, leukemia-related deaths typically become apparent in the late winter or early spring (January or February) and gradually decline in autumn (September or October). The trend observed in Europe and China reflects that leukemia is more common in warm, humid climates but can occur at any time of year.

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What does cyclophosphamide usually treat?

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This article describes the common treatment for acute or chronic lymphocytic leukemia when patients are treated with cytostatic agents, specifically cyclophosphamide. I.v. cyclophosphamide should be given.

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What is the primary cause of leukemia?

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Leukemia may be caused primarily by environmental exposures; however, genetic mutations are a major cause because all cells in the body have genes that may cause cancer. The cancer is called leukemia because it affects the white blood cells (leukocytes) in the bloodstream. The white blood cells are constantly being born and dying in our blood. The number can also vary a lot. Those cancer cells that don't get caught and killed by immune cells stay in the blood and become dormant. Then when they are in the right place, they can make a person sick.

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What is the latest research for leukemia?

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The research agenda for the treatment of acute leukemia is diverse, focused on research into molecular and targeted therapeutics, and the development and application of novel agents, the development of novel agents based on resistance mechanisms, and new approaches to relapse.

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