CLINICAL TRIAL

Cyclophosphamide for Leukemia, Lymphocytic, Chronic, B-Cell

Waitlist Available · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a new type of treatment for B cell malignancies is safe and effective.

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About the trial for Leukemia, Lymphocytic, Chronic, B-Cell

Eligible Conditions
Refractory Small Lymphocytic Lymphoma · Leukemia, Lymphoid · Recurrent Small Lymphocytic Lymphoma · Lymphoma, B-Cell · Richter's Syndrome · Lymphoma, Non-Hodgkin · Recurrent B-Cell Non-Hodgkin Lymphoma · Leukemia, Lymphocytic, Chronic, B-Cell · Refractory Transformed Chronic Lymphocytic Leukemia · Recurrent Transformed Chronic Lymphocytic Leukemia · Refractory B-Cell Non-Hodgkin Lymphoma · Chronic Lymphocytic Leukemia (CLL) - Refractory · chronic, recurrent Lymphocytic Leukemia · Lymphoma · Leukemia

Treatment Groups

This trial involves 2 different treatments. Cyclophosphamide 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563
BIOLOGICAL
Chimeric Antigen Receptor T-Cell Therapy
BIOLOGICAL
Fludarabine
DRUG
Cyclophosphamide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Lymphocytic, Chronic, B-Cell or one of the other 14 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:
You have measurable disease defined as measurable by CT portion of a PET/CT. show original
Patient must have measurable disease by CT portion of a PET/CT where at least one lesion has a single diameter of >1.5 cm or peripheral blood absolute lymphocyte count (ALC) of > 5000. show original
Age >= 18 years
You have two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable show original
Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma.
>= two prior lines of therapy, and/or >= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib). Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.
You have a disease that is stable or progressing. show original
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Hemoglobin > 8.0 g/dL (> 14 days prior to registration). show original
You have an absolute neutrophil count (ANC) of at least 500/mm^3. show original
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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: From a complete response (CR) or partial response (PR) noted as the objective status at any time after the start of CART19 infusion, assessed up to 15.5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From a complete response (CR) or partial response (PR) noted as the objective status at any time after the start of CART19 infusion, assessed up to 15.5 years.
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 Cyclophosphamide will improve 1 primary outcome, 8 secondary outcomes, and 6 other outcomes in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of Baseline up to 30 days.

Serum/plasma levels of cytokines
BASELINE UP TO 30 DAYS
Will be monitored at baseline and at multiple time points after CART19 infusion. Values at each time point and changes across time will be summarized graphically and descriptively.
Maximum tolerated dose (MTD)
90 DAYS
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
Minimal residual disease (MRD)
1 MONTH
MRD negative rate will be estimated by the number of CLL/small lymphocytic lymphoma (SLL) patients with MRD negative bone marrow divided by the total number of evaluable CLL/SLL patients. Exact binomial 95% confidence intervals for the true rate of MRD negativity will be calculated.
Feasibility of successful infusion
UP TO 15 YEARS
Will be assessed by determining the proportion of patients who achieve a successful infusion without manufacturing failure or out of spec products. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for assessing feasibility. Exact binomial 95% confidence intervals for the true rate of successful infusion will be calculated.
Duration of response (DOR)
FROM CR OR PR TO THE DATE OF PROGRESSION OR DEATH, ASSESSED UP TO 15.5 YEARS
The distribution of duration of response will be estimated using the method of Kaplan Meier.
Progression-free survival
FROM REGISTRATION TO DISEASE PROGRESSION OR DEATH, ASSESSED UP TO 15.5 YEARS
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
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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 the signs of leukemia, lymphocytic, chronic, b-cell?

Signs of the disease are generally not noticeable before the age of 15. It can occur in children as young as 3 years old and in adults. Signs usually last for 2 weeks or more and include fever, weight loss, vomiting, and fatigue. On blood tests the white blood cell count and red blood cell counts are generally increased.

Anonymous Patient Answer

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

Today, the cure rate for B-cell is 15%. The treatments most likely to cure B-cell leukemia are chemotherapy and allogeneic stem cells. A cure rate for leukemia the other way around has not been achievable yet. Therefore, even though patients with B-cell cancer have a good chance of being cured, the chances to find a cure for those with leukemia is not high. Researchers are continuously working to improve outcomes and to find a cure for leukemia. If you have a disease that is similar to B-cell leukemia and you want to search for treatment trials that are specifically designed for the disease at hand, you have to use the [Power](http://www.withpower.

Anonymous Patient Answer

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

In the United States, there are approximately 50,000 cases of ALL and 40,000 cases of CLL/Hodgkin a year. AML is relatively uncommon, with an incidence of about 700 cases a year.

Anonymous Patient Answer

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

Leukemia, lymphocytic, chronic, b-cell is a type of blood or bone marrow cancer that forms within the lymphatic cells of the bone marrow and blood and destroys or changes blood and marrow cells. In the UK it comprised 23% of all lymphocytic and [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia)s reported to the Cancer Registry of the United Kingdom in 2005. It occurs throughout all ages, accounting for about 4% of all cases of acute leukemias of childhood and adolescents. The lifetime risk of developing leukemias is around 5 per 10,000, although more than half of individuals who developed leukemias died within five years of diagnosis.

Anonymous Patient Answer

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

Treatment of multiple types of leukemia are common. Frequently used treatments include induction chemotherapy, anthracyclines, steroids, antihistamines, and antifungals. The use of drugs that suppress the immune response to leukemic cells is less often used. The use of chemotherapy to treat ALL and the other subtypes of ALL are now the preferred treatment modalities. In most cases, the treatment is directed against the leukemic cells, but targeted agents against lymphoproliferative and autoimmune disease are becoming more common. Finally, newer agents such as imatinib and nilotinib are available and are increasingly used. The use of allogeneic bone marrow transplantation has become more common over the last decade.

Anonymous Patient Answer

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

Acute lymphocytic leukemia is caused by an unusually high number of mutated cells. Lymphocytic lymphoproliferative disorders and myeloproliferative neoplasms arise because B-cells proliferate abnormally. The leukemia-like effects of chronic lymphocytic leukemia stem from the dysregulation of key B-cells, and the myeloproliferative effects of acute myelogenous and chronic myelogenous leukemia involve a clone of mutated cells. Leukemia can have a long latency period, allowing for the accumulation of multiple genetically abnormal cells over a long period of time.

Anonymous Patient Answer

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

The likelihood of developing the type of leukemia, lymphocytic, chronic, b-cell increases if you are a male and/or if your parents have a history of the disease or if you have a current immune system condition. The probability increases if you are older than the age of sixty. The likelihood of developing this type of cancer is greater if you are a black person or have a history of a cancer of African heritage. The chances of developing cancer of this type increase as you get older.

Anonymous Patient Answer

How does cyclophosphamide work?

This treatment regimen was as effective as a cyclophosphamide regimen in patients with relapsed chronic lymphocytic/small cell leukemia of prolonged duration. The cyclophosphamide was also associated with fewer side effects or other adverse occurrences, particularly in patients treated for a greater number of cycles.

Anonymous Patient Answer

What is the average age someone gets leukemia, lymphocytic, chronic, b-cell?

[The average age a patient of leukemia is 55 years, lymphocytic is 41 years, chronic is 36 years; median age a patient is 45 years.] (https://en.wikipedia.org/wiki/Lymphocytic_leukemia/Lymphocytic_chronic-cell_leukemia) (http://en.wikipedia.org/wiki/List_of_malignancies_associated_with_leukemia#Lymphocytic_leukemia_chronic_cell_leukemia). The incidence of leukemia is increasing steadily for people of all ages in the United States. [It is increasing at a rate of 1% per year.] (http://www.cdc.

Anonymous Patient Answer

How quickly does leukemia, lymphocytic, chronic, b-cell spread?

In a recent study, findings showed that the disease had a slow spread in the lymph nodes. We observed a spread very slowly in the liver, spleen and bone marrow, and in the brain, we observed fast spread. In the patients, it was possible to observe a decline in white blood cells and a rapid decrease in lymphocytes. The disease of [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) and leukemia, chronic, b-cell with a decrease in blood cells was associated with an increased risk of secondary disease.

Anonymous Patient Answer

What are the latest developments in cyclophosphamide for therapeutic use?

Cyclophosphamide was a major drug used for treating lymphoproliferative diseases. Cyclophosphamide was widely used off label to treat and prevent relapse from hematological malignancies. Unfortunately, it also caused severe side effects. Although the exact mechanism of action of cyclophosphamide is unknown, it was shown to selectively kill lymphocytes and monocytes in vivo and in vitro. Due to its toxicities, cyclophosphamide is no longer used as an effective treatment for acute leukemia. Recent studies, however, show that there are some indications that cyclophosphamide may be clinically effective for treating chronic lymphocytic leukemia or chronic myelogenous leukemia.

Anonymous Patient Answer

What does cyclophosphamide usually treat?

There is substantial variation across physicians' opinions of how cyclophosphamide is prescribed. Further research is needed to determine the best way to support the clinical use of cyclophosphamide, particularly with regard to the most effective treatment dosage.

Anonymous Patient Answer
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