Clofarabine for Leukemia

Phase-Based Estimates
1
Effectiveness
2
Safety
Penn State Cancer Institute, Hershey, PA
Leukemia+3 More
Clofarabine - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether a specific chemotherapy regimen followed by a transplant may help individuals with leukemia.

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Clofarabine will improve 1 primary outcome and 6 secondary outcomes in patients with Leukemia. Measurement will happen over the course of 30 days.

1 year
Incidence of Chronic GVHD
Neutrophil engraftment
Severity of Chronic GVHD
100 days
Incidence of Acute graft-versus-host disease (GVHD)
Non-relapse related mortality
Severity of Acute graft-versus-host disease (GVHD)
30 days
Incidence of complete remission (CR)

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

2 Treatment Groups

Control
Clofarabine 30 mg/m^2

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Clofarabine 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.

Clofarabine 30 mg/m^2Day -14 through Day -10 Clofarabine 30 mg/m^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 40 mg/m^2 IV and Busulfan 3.2 mg/kg IV (Regimen A, Fludarabine 24 mg/m^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B), Day - 5 Fludarabine 40 mg/m^2 IV and Busulfan 3.2 mg/kg IV (Regimen A, Fludarabine 24 mg/m^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B), Day - 4 Fludarabine 40 mg/m^2 IV(Regimen A, Fludarabine 24 mg/m^2 IV for Regimen B), Day - 3 Fludarabine 40 mg/m^2 IV(Regimen A, Fludarabine 24 mg/m^2 IV for Regimen B), Day - 2 Day of Rest, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Fludarabine
FDA approved
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1000
Busulfan
FDA approved
Clofarabine
FDA approved
Mycophenolate mofetil
FDA approved
Cyclophosphamide
FDA approved
Tacrolimus
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Who is running the study

Principal Investigator
S. N.
Prof. Seema Naik, MD
Milton S. Hershey Medical Center

Closest Location

Penn State Cancer Institute - Hershey, PA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Leukemia 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:
People who are scheduled to receive an allogeneic HSCT from haploidentical related donors, matched and mismatched unrelated donors. show original
The person has a good pulmonary function with a forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) of more than 50% of the predicted value and a diffusion capacity for carbon monoxide (DLCO) of more than 50% of the predicted value. show original
Testing of organ function should be done within 28 days of when someone signs up for a study. show original
The text refers to people aged 18 to 75. show original
Both men and women need to use birth control to avoid exposing the fetus to unknown risks. show original
The person has a good performance status, with a Karnofsky score of 70% or higher. show original
This means that the person's creatinine clearance is more than 60 ml per minute per 1.73 meters squared. show original
Heart: LVEF (left ventricular ejection fraction) is 50% or more by MUGA (multiple-gated acquisition) or echocardiogram. show original
AML is diagnosed in individuals who have not achieved remission after at least 2 attempts at induction chemotherapy, or those who have relapsed after any complete remission. show original
The patient has no evidence of significant hepatic dysfunction, as indicated by a serum bilirubin level that is ≤1.5 times the upper limit of normal, an AST/ALT ratio that is ≤ 2.5 times the upper limit of normal, and an alkaline phosphatase level that is ≤2.5 times the upper limit of normal. 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 is leukemia?

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Leukemia, also called chronic blood cell disease, is a group of abnormal blood cell malignancies that can develop in people of all ages. It may be the first sign of a more advanced type of cancer that has spread to other organs such as the brain or bone. Diagnosis at the proper time is imperative for an accurate future prognosis. The initial steps in diagnosis are blood screening tests to search for blood abnormalities and bone marrow examination to determine the type and severity of the disease. Treatment for leukemia is a chemotherapy plan that includes drugs to destroy abnormal blood cells and normalize blood cell levels. In some cases, non-hormonal drugs and surgery may be combined for better treatment.

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Can leukemia be cured?

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Leukemia remains a chronically debilitating and life-threatening disease. With current technologies, cure is difficult to achieve, and progress toward a cure still remains a remote possibility. However, recent advances in chemotherapy coupled with new and potentially more effective monoclonal antibody therapies offer promise for the future.

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

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Around 9,000 people get leukemia in the USA each year. In America, leukemia is one of the most common forms of cancer diagnosed in individuals aged 15 to 44 years old. It has the most in-patient stays.

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What causes leukemia?

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Causes of leukemia include genetic mutation as well as environmental factors such as occupational exposure and infectious disease. Tobacco smoking, exposure to radiation and chemical toxins such as Agent Blue and benzene and ionizing radiation, and chronic alcohol abuse are known risk factors for leukemia. Other environmental and immunological factors such as viruses, bacteria and parasites may also be involved, but their mechanism is not well understood.\n

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What are common treatments for leukemia?

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There is considerable overlap between the treatments for leukemia. Bone marrow transplants are used frequently in the treatment of chronic phase leukemias. Hematopoietic stem cell transplants are often used in the treatment of acute phase leukemias. Acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDS) are often treated with high dose chemotherapy, autologous stem cell transplantations (ASCT) or allogeneic stem cell transplantations (SCT). Patients with advanced lymphoma often receive chemotherapy. For women with breast cancer, surgery can be done, especially in the early stages of breast cancer. It is also done after radiation treatment.

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What are the signs of leukemia?

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Leukemia symptoms include fever, fatigue, nausea, pain and/or shortness of breath. These signs need to be supported by a full blood count. Patients who present with symptoms of leukemia must be admitted to hospital.

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How does clofarabine work?

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In vitro, clofarabine-based chemotherapy is a novel therapeutic strategy that selectively targets the cancer stem cell population. A synergistic antitumor effect is achieved by this method, which is accompanied by less toxicity than currently used conventional cytostatic therapies.

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What is the average age someone gets leukemia?

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The average age someone should get leukemia was 47.5 years old. The age of the patient did not correlate with the age at diagnosis of the disease. I have leukemia and had it when I was 26 and is now 44. Although the average age a person has leukemia is 46 years old, there are individuals who get the disease when they are 20 or younger. One man I had known was 15 when diagnosed with leukemia. His father was also diagnosed with leukemia when he was 15

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Is clofarabine typically used in combination with any other treatments?

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The incidence of AEs reported with clofarabine is similar to that reported with the other nucleoside/nucleotide prodrug regimen combinations. Although no conclusions can be drawn as to safety or effectiveness of clofarabine based regimens versus other approaches in the current context, this study provides the information to ensure that clinicians know about the risks and benefits of each regimen in the context of an individual patient's condition.

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What are the chances of developing leukemia?

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There are chances of developing leukemia. If you are diagnosed with chronic leukemia, which is myeloid or lymphoid the chances are higher but still low. The chances of developing leukemia are lower if a patient has an autoimmune disease before getting leukemia, this is very common but is due to certain genetics.

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What are the common side effects of clofarabine?

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Common side effects of clofarabine are nausea and vomiting, decreased appetite, vomiting or nausea/vomiting more than 7% of the time, stomatitis, rash or itchy skin, diarrhea/abdominal pain, constipation or urinary disorders, insomnia or hypersomnia, headache, tinnitus or ringing in ears, numbness or tingling, back pain, loss of muscle strength, weakness, trouble seeing, and dizziness/lightheadedness.

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Does clofarabine improve quality of life for those with leukemia?

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Findings from a recent study suggests that the improvements in social and physical QoL for patients receiving clofarabine are not limited by the toxic effects of the medication itself, but by the patient's general health status.

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