Ofatumumab for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, MD
Leukemia, Lymphocytic, Chronic, B-Cell+5 More
Ofatumumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Lymphocytic, Chronic, B-Cell

Study Summary

This study is evaluating whether a drug called ofatumumab can be used to treat people with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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Eligible Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia
  • Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ofatumumab will improve 1 primary outcome in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of 2 years.

2 years
Progression Free Survival Rate 2 Years After Initiation of Induction Therapy

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

No Control Group
FO Arm (fludarabine and ofatumumab)

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ofatumumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

FO Arm (fludarabine and ofatumumab)For patients with non-high risk FISH changes
FCO Arm (fludarabine, cyclophosphamide, and ofatumumab)For patients with high risk FISH changes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If there is lymphadenopathy present with histologic confirmation of lymph node involvement, then the number of B-lymphocytes may be less than 5000 cells/micro L. show original
A person who has lost more than 10 percent of their weight within the previous 6 months is considered to have a weight problem. show original
Appropriate immunophonotype (CD5/19/23+)
This text confirms that the clonality of lymphocytosis has been confirmed by flow cytometry. show original
The majority of lymphocytes in blood are large lymphocytes show original
Extreme fatigue
Fevers of greater than 100.5 degree F for greater than or equal to 2 weeks without evidence of infection
Night sweats for more than one month without evidence of infection
Doctor's notes indicate that the patient has been progressively losing blood and platelets, resulting in anemia and difficulty clotting. show original
The immunophenotypic profile of the cells is consistent with CLL, as demonstrated by flow cytometry. 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 causes leukemia, lymphocytic, chronic, b-cell?

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For the development of a malignant leukemia, a combined action of different environmental and genetic factors plays an important role. Among them, the most important is an increase of the number of cells in the bone marrow, and this action can be caused by irradiation of the body. The high rate of occurrence of lymphoid and myeloid neoplasms was probably caused by occupational hazards as well as infections with certain bacteria and protozoans.

Unverified Answer

Can leukemia, lymphocytic, chronic, b-cell be cured?

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A cure for leukemia, lymphocytic, chronic, b-cell is not reasonable. A cure cannot be obtained immediately, and some patients will die from the disease and will be better off when it terminates. We may be better off if we manage this disease. This may not happen immediately; it may occur more than once; even if the cure is achieved, the disease will recur. Leukemia, lymphocytic, chronic, b-cell, can be managed well, but it is best managed by the treatment of secondary symptoms.

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What are the signs of leukemia, lymphocytic, chronic, b-cell?

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While most patients’ symptoms and signs improves upon complete remission, the exact course of their recovery is still uncertain and varies from person to person. It is important to be aware of patients with leukemia, lymphocytic, chronic, b-cell that is currently stable or experiencing the first flare to monitor for any complications. It is also necessary to monitor for the presence of myelodysplastic syndrome (MDS) or clonal or premalignant conditions; in addition to treatment for these conditions that can occur, which include medication side effects and the risk of new clonal conditions. Patients may require a specific type of chemotherapy to treat their leukemia.

Unverified Answer

What are common treatments for leukemia, lymphocytic, chronic, b-cell?

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Common treatment for leukemia include chemotherapy and sometimes immunomodulator (IM) therapy. Other treatments include supportive care, physical therapy and occupational therapy. Cancer-related fatigue can be treated with psycho-behavioral intervention.

Unverified Answer

What is leukemia, lymphocytic, chronic, b-cell?

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Leukemia is a disease of blood cell production, most commonly affecting the bone marrow, in which the production of white blood cells or red blood cells becomes too low or too rapid. The disease is often chronic, presenting in one or more body systems. Most commonly occurring in adults, it has been one of the most devastating diseases of childhood, causing deaths and disabling conditions in childhood and adulthood. Lymphocytic, chronic, b-cell, is a rare type of leukemia thought to occur in infants, toddlers and children.

Unverified Answer

How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

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About 20,000 people are diagnosed with lymphoma, [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia), and chronic B-cell lymphocytic leukemia a year, most cases being diagnosed in adults, with a male predominance (male:female 10:1).

Unverified Answer

Is ofatumumab safe for people?

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No drug-drug interactions were observed. However, no data were obtained on the absorption, distribution, metabolism, or elimination of the drug. Pharmacokinetics were not investigated in this clinical trial.

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What is the primary cause of leukemia, lymphocytic, chronic, b-cell?

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In the 1960s and afterward, people diagnosed with Leukemia had an overall mortality rate of 27%. From 1970 through 1994, the death rates steadily decreased. There is no reason to believe that the [cause of leukemia and lymphocytic, chronic, b-cell] is different from Leukemia in the past. Today, we find that the disease is no different in its mode of occurrence, location, and incidence. The primary causes of leukemia are environmental: a combination of smoking and alcohol are involved with 80%+ of American cases. Leukemia in both adults and children is related to tobacco smoke, which causes multiple organ organ damage and cancer.

Unverified Answer

What is the latest research for leukemia, lymphocytic, chronic, b-cell?

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[It is possible to get leukemia, lymphocytic, chronic, b-cell in your armpits]](https://www.leukemia.org /treatment) for the right treatment. This is due to how Leukemia Clinical Trials, Inc. divides leukemia into categories and what Cancer Treatment, Inc. calls “types” for each group. Most leukemia treatments take the form of specific drug therapies. To find leukemia treatments in your area, you can use[Power(https://www.power.

Unverified Answer

What are the latest developments in ofatumumab for therapeutic use?

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Recent data have shown that ofatumumab therapy has been shown to achieve durable responses in patients with relapsed or refractory B-cell lymphoma. Additionally, it has also shown its ability to be used effectively in the treatment of CLL with relative ease of toxicity.

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Have there been other clinical trials involving ofatumumab?

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Clinically significant improvement occurred in two patients out of the four treated in this cohort. On the basis of these results, the clinical benefit of ofatumumab may be considered and the drug may be more widely investigated in a more appropriately designed registry.

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What are the common side effects of ofatumumab?

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The side effects of ofatumumab depend on the type of leukemia the patient's disease resembles. Lymphoblastic leukemias (CLL, Non-Hodgkin lymphoma, Hodgkin lymphoma) have been seen to respond more to ofatumumab than myeloid disorders (myeloblastosis, chronic myelogenous leukemia, acute myelogenous leukemia) with response defined as the attainment of at least an 85% decrease in the tumor burden assessed by a 90% decrease in the bone marrow, peripheral blood or central nervous system by a minimum of one evaluator and no new lesions by an independent evaluator.

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See if you qualify for this trial
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