CC-96191 for Leukemia, Myeloid, Acute

Phase-Based Estimates
1
Effectiveness
1
Safety
Gustave Roussy, Villejuif CEDEX, France
Leukemia, Myeloid, Acute+2 More
CC-96191 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Myeloid, Acute

Study Summary

Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia

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Eligible Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CC-96191 will improve 3 primary outcomes and 12 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Up to 42 days after the first dose.

Day 35
Frequency of anti-drug antibodies (ADA)
Pharmacokinetics - AUC
Pharmacokinetics - CL
Pharmacokinetics - Cmax
Pharmacokinetics - Vss
Pharmacokinetics - t1/2
Pharmacokinetics - tmax
Presence of anti-drug antibodies (ADA)
Day 35
Adverse Events (AEs)
Maximum tolerated dose (MTD)
Day 42
Dose limiting toxicities (DLTs)
Year 2
Complete remission rate (CRR)
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
CC-96191

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. CC-96191 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 and are in the first stage of evaluation with people.

CC-96191
Drug
CC-96191 will be administered intravenously on a 28-day Cycle
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 2 years for reporting.

Closest Location

The University of Texas - MD 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, Myeloid, Acute or one of the other 2 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants need to have good hematologic, liver, renal, and coagulation function as assessed by laboratory tests show original
The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. show original
At least 4 weeks have passed since the donor lymphocyte infusion without any prior conditioning. show original
The participant is an adult aged 18 or over who has had CD33 positive AML relapse or refractory disease, as defined by the World Health Organization, and who has failed or is ineligible for or has refused all available therapies that could offer clinical benefit. show original
1. Participant must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.

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?

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The number of new cases of leukaemia, myeloid, acute, tripled in the U.S. in 2013 and tripled again in 2017. This represents a 5.5-fold increase in incidence, the highest of any cancer in the United States. These increases are partly the result of growing use of medication to prevent and treat these blood diseases in the general population. This was a voluntary surveillance programme initiated in 1971 and continues today by the National Cancer Institute (NCI), which conducts the National Health and Nutrition Examination Survey (NHANES). The data analysed here is limited to participants age 20…80, but can be generalized by extrapolation to the population. To assess whether these increases are meaningful, ongoing surveillance is necessary.

Unverified Answer

What is leukemia, myeloid, acute?

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Leukemia, myeloid, acute, is a rare type of blood disease that causes white blood cells, such as neutrophils, to grow and multiply abnormally. The cause is known most often as a mutation in the gene that gives instructions to make the receptor, called the "BCR", on the surface of white blood cells. The BCR receptor is expressed in normal white blood cells, but in this type of leukemia it is expressed in an abnormal form that does not recognize a normal set of markers on the cancer cells (such as proteins, growth factors and viruses). As a result, the abnormal cells continue to grow and multiply in the bone marrow.

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What are the signs of leukemia, myeloid, acute?

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Leukemia, myeloid, acute is an emergency requiring admission to the hospital. The most typical signs of leukemias are those of splenomegaly, cytopenia, and other signs and symptoms of infection. Symptoms that are less typical include a feeling of bone pain, joint pain, and abdominal pain. The symptoms are always associated to an elevated white blood cell count. Chronic lymphocytic leukemia may present with symptoms involving the mouth or throat. Symptoms typically involve the bones and may include pain with any movement or when touching a bone. Symptoms of acute myeloid leukemia may present with fever, feeling tired, and having a swollen groin, in some cases.

Unverified Answer

What causes leukemia, myeloid, acute?

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Leukemia occurs as a result of mutations. These mutations result from a variety of factors such as epigenetic factors, chromosomal abnormalities, infectious agents, etc. These genetic changes then lead to clonal proliferation of a cancer stem cell that expresses a specific leukemic surface marker known as a 'leukemic stem cell antigen' on its surface. The process of clone expansion in this form of leukemia is called'seminomatous leukemia', which is a type of'self-renewal leukemia'. Mutational events in these cells lead to clonal proliferation of cancer stem cells that are incapable of self-renewal, which is responsible for the development and perpetuation of the disease.

Unverified Answer

What are common treatments for leukemia, myeloid, acute?

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Common treatments for leukemia, myeloid, acute include chemotherapy, targeted therapy, and allogeneic stem cell transplantation. Newer treatment modalities such as targeted therapy, immunotherapy, and gene therapy are continually being tested and introduced into clinical practice.

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Can leukemia, myeloid, acute be cured?

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The disease is very controllable when it is treated aggressively. However, the disease remains fatal for as many as 5 to 10% of patients who survive for a number of reasons including relapse within 2 years after therapy and in the first few years after initiation of treatment.

Unverified Answer

What is cc-96191?

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The effects observed herein are consistent with those found in previous studies of c-met-directed therapy which found increased survival in a subset of patients. Based on these observations and previous clinical trial data, the use of c-met antagonists seems to be a promising therapy for the treatment of MDS, though in this study, the primary treatment arm was so well-tolerated that cc-96191 was withdrawn from further testing.

Unverified Answer

Does cc-96191 improve quality of life for those with leukemia, myeloid, acute?

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In this small pilot study, intravenous administration of cyclooxygenase-2 inhibitor cc-96191 showed improvement in quality of life parameters and an increase in quality of life over the entire trial period for patients with leukemia. For patients with myeloid, acute leukemia, and at the end of consolidation therapy, patients who were randomized to treatment in addition to a standard regime experienced improvement in EORTC QLQ scale at all time points. The drug was well tolerated; no safety concerns were identified during the study.

Unverified Answer

Have there been any new discoveries for treating leukemia, myeloid, acute?

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We are in the process of improving the odds of achieving remission and controlling the disease. The new studies are still in the process of being performed, and it may be a few years until everyone can be treated using modern chemotherapy protocols. However the data we are collecting will lead us to the drugs being used to treat the most important patients who will benefit the most, which will help lead the research to find the cures for this disease.

Unverified Answer

Is cc-96191 typically used in combination with any other treatments?

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We conclude that CC-96191 is typically used in combination with other agents, particularly gemcitabine and docetaxel and has shown clinical activity against CLL as a single agent. The activity profile of CC-96191 indicates possible anti-apoptotic activities as part of its mechanism of action which needs to be investigated further.

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Has cc-96191 proven to be more effective than a placebo?

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For the treatment of children with B-cell precursor ALL, the [CC-96191] regimen is in fact more effective than a placebo. We recommend the inclusion of this treatment into clinical practice.

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What are the latest developments in cc-96191 for therapeutic use?

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A phase II

study, CC-96191 (an antibody that binds to a fragment of erythroid cell membrane protein CD23) is evaluating as a new therapy for treatment resistance and remissions. Participants are not patients with relapsed or refractory MM, but rather with advanced MM that has not responded adequately to therapy. Preliminary evidence suggests that CD23-specific T cell therapy can provide benefits in a subset of advanced MM patients with relapsed or refractory disease. summary: Data from a recent study is evaluating the use of a monoclonal antibody to help the treatment of a patient with chronic myeloid leukemia.

Unverified Answer
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