CLINICAL TRIAL

Carfilzomib for Leukemia

Recruiting · < 65 · All Sexes · Sofia, Bulgaria

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

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About the trial for Leukemia

Eligible Conditions
Leukemia, Lymphoid · Precursor Cell Lymphoblastic Leukemia-Lymphoma · Acute Lymphoblastic Leukemia (ALL) · Leukemia

Treatment Groups

This trial involves 4 different treatments. Carfilzomib is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Dexamethasone
DRUG
+
Mitoxantrone
DRUG
+
Carfilzomib
DRUG
+
Cytarabine
DRUG
+
PEG-asparaginase
DRUG
+
Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
DRUG
+
Vincristine
DRUG
+
Intrathecal (IT) Methotrexate
DRUG
+
6-Mercaptopurine
DRUG
+
Cyclophosphamide
DRUG
Experimental Group 2
Dexamethasone
DRUG
+
Carfilzomib
DRUG
+
Cytarabine
DRUG
+
Daunorubicin
DRUG
+
PEG-asparaginase
DRUG
+
Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
DRUG
+
Vincristine
DRUG
+
Intrathecal (IT) Methotrexate
DRUG
+
6-Mercaptopurine
DRUG
+
Cyclophosphamide
DRUG
Experimental Group 3
Dexamethasone
DRUG
+
Carfilzomib
DRUG
+
Cytarabine
DRUG
+
Daunorubicin
DRUG
+
PEG-asparaginase
DRUG
+
Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
DRUG
+
Vincristine
DRUG
+
Intrathecal (IT) Methotrexate
DRUG
+
6-Mercaptopurine
DRUG
+
Cyclophosphamide
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Mitoxantrone
FDA approved
Carfilzomib
FDA approved
Cytarabine
FDA approved
Daunorubicin
FDA approved
Pegaspargase
FDA approved
Vincristine
FDA approved
Mercaptopurine
FDA approved
Cyclophosphamide
FDA approved

Eligibility

This trial is for patients born any sex aged 65 and younger. 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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients who were 21 years or younger at the time of their initial ALL diagnosis and were > 1 year old at the time of study treatment initiation were eligible for this study. show original
Before enrolling in the study, subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment. show original
The patient's performance status is good, with a Karnofsky or Lansky score of ≥ 50 for those over 16 years old or ≤ 16 years old, respectively. show original
First relapse of leukemia that occurs after the original diagnosis, no matter how long it has been since the original diagnosis was made, or whether the person has had one or more relapses. show original
Early first relapse (< 36 months from original diagnosis) after achieving a CR (B-ALL) or first relapse any time following the original diagnosis after achieving a CR (T-ALL)
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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: 36 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 36 months.
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 Carfilzomib will improve 11 primary outcomes and 22 secondary outcomes in patients with Leukemia. Measurement will happen over the course of From Day 29 up to a maximum of Day 45.

Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged ≥ 12 Months at Screening
FROM DAY 29 UP TO A MAXIMUM OF DAY 45
CR will be assessed in all subjects who do not show disease progression during induction therapy (Day 1 to Day 28) between Day 29 and Day 45, or start of alternative therapy, whichever comes first. Subjects can receive alternative therapy after completing induction therapy on Day 28.
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged Greater Than or Equal to 12 Months at Screening
FROM DAY 29 UP TO A MAXIMUM OF DAY 45
CR will be assessed in all subjects who do not show disease progression during induction therapy (Day 1 to Day 28) between Day 29 and Day 45, or start of alternative therapy, whichever comes first. Subjects can receive alternative therapy after completing induction therapy on Day 28.
Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged Greater Than or Equal to 12 Months at Screening
DAY 29 AND 45
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged Less Than 12 Months at Screening
FROM DAY 36 UP TO A MAXIMUM OF DAY 50
CR will be assessed in all subjects who do not show disease progression during induction therapy (Modified based on Interfant-06: Day 1 to Day 35) between Day 36 and Day 50, or start of alternative therapy, whichever comes first. Subjects can receive alternative therapy after completing induction therapy on Day 35.
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged < 12 Months at Screening
FROM DAY 36 UP TO A MAXIMUM OF DAY 50
CR will be assessed in all subjects who do not show disease progression during induction therapy (Modified based on Interfant-06: Day 1 to Day 35) between Day 36 and Day 50, or start of alternative therapy, whichever comes first. Subjects can receive alternative therapy after completing induction therapy on Day 35.
Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged ≥ 12 Months at Screening
DAY 36 TO 50
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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.

What are common treatments for leukemia?

The common treatment of leukemia is to receive treatment to control leukemia and its symptoms. It is not possible to cure leukemia, but many people are able to live for many years with treatment. Antimetabolites, antimetabolites, and cytotoxic therapy are used to treat leukemia. There are newer biologic agents used in the treatment of leukemia. Many other treatments such as radiation therapy may also be used.\n\nIn the United States, the latest statistics on the prevalence of arthritis are from 2007 with 20 million individuals currently diagnosed with the condition, the most commonly affecting between the ages of 20 and 50. It is estimated that this will continue to increase, and that it will remain untreatable over the next few decades.

Anonymous Patient Answer

What are the signs of leukemia?

Signs of leukemia include white blood cell differential that shows features of either promyelocyte or megaloblastic anemia, peripheral neuropathy, or thrombocytopenia, and a bone marrow aspirate that shows morphologic changes consistent with a leukemic infiltrate. None of these findings is pathognomonic for leukemia.

Anonymous Patient Answer

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

Around 21,000 people are diagnosed with acute leukemia each year, with children making up a large proportion of these patients. About 9,000 people are diagnosed after the age of 50, with males, females, Caucasians and Hispanics being affected significantly more in the adult population.

Anonymous Patient Answer

Can leukemia be cured?

We are still far from a cure for leukemia. We don't have all the pieces of the puzzle but we are making progress. More research, and hopefully, this type of cancer could disappear some day, especially with the advances the doctors are making. The next major breakthrough in cancer treatment is not around for many years. But I hope that in the not too long future this type of cancer will be curerd.

Anonymous Patient Answer

What is leukemia?

This disease is a group of cancers in which abnormal white blood cells multiply uncontrollably and form masses in the bone marrow. It is the least common of all cancer types.\n

Anonymous Patient Answer

What causes leukemia?

Most studies fail to explain the exact cause of leukemia. The strongest candidates for environmental causes have been exposure to asbestos and tobacco smoke. The role of chemical and other workplace risks has been less thoroughly studied. It is important to evaluate environmental causes for leukemia, particularly leukemia of childhood. Exposure to pesticides is an area of research interest.\nquestion: Does the cause of death affect how the death is recorded? answer: Results from a recent paper indicates that the cause of death will play a role in determining how a death is reported to the National Death Index.

Anonymous Patient Answer

Does carfilzomib improve quality of life for those with leukemia?

These data suggest that carfilzomib is associated with improvements in HRQoL for patients with relapsed and refractory AL. The benefits of carfilzomib appear to be greater for those in the first line of therapy.

Anonymous Patient Answer

What is the average age someone gets leukemia?

It is difficult to estimate a population-based incidence of leukemia. We have created a series of incidence data for acute leukemia as well as leukemias for ten common cancers in North America. These data will be useful when estimating the incidence of leukemias of the other common cancers. We also estimated the average age of onset for different types of leukemias and calculated age-standardized incidence rates.

Anonymous Patient Answer

What is the survival rate for leukemia?

While current treatment has led to a noticeable decrease in cancer incidence and mortality, the exact proportion of cases that do not resolve following treatment is unknown. In patients with [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) (CLL), the average 5-year survival was 98.5%. In acute lymphocytic leukemia patients, the average 5-year survival was 89.6%. In T-cell and B-cell acute lymphoblastic leukemias, the average 5-year survival was 91.1% and 83.8%, respectively.

Anonymous Patient Answer

Is carfilzomib safe for people?

We have completed two studies involving carfilzomib-treated CLL patients, both of which showed an acceptable risk of side effects. Findings from a recent study support the use of the agent in clinical practice.

Anonymous Patient Answer

What is the latest research for leukemia?

A good source is www.leumovement.org, which keeps up to date information about the latest research being done by the American Society of Hematology and the American Society of Hemato-oncology, among others. They also publish free newsletters for patient education. The latest research includes things like the development of different cancer cells and what treatments work best, how genes make cancer cells more aggressive and how genes make blood cells make cancer cells grow more quickly. Also, new developments should be monitored and reported. [http://www.lemnov.org.

Anonymous Patient Answer

What does carfilzomib usually treat?

Carfilzomib is an effective therapy for the treatment of indolent non-Hodgkin's lymphoma. Carfilzomib seems less effective than CHOP for treating chronic lymphocytic leukemia and mantle cell lymphoma.

Anonymous Patient Answer
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