CLINICAL TRIAL

Ipilimumab for Lymphoma

1 Prior Treatment
Refractory
Relapsed
Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether ipilimumab in combination with ibrutinib or ibrutinib and nivolumab is safe and effective in treating patients with CLL and RT.

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About the trial for Lymphoma

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

Treatment Groups

This trial involves 2 different treatments. Ipilimumab 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 1 and are in the first stage of evaluation with people.

Experimental Group 1
Ibrutinib
DRUG
+
Ipilimumab
BIOLOGICAL
Experimental Group 2
Ibrutinib
DRUG
+
Nivolumab
BIOLOGICAL
+
Ipilimumab
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Nivolumab
FDA approved
Ipilimumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 9 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:
Cohort 2: Patients with CLL or SLL who have been treated with ibrutinib for at least 9 months and have had persistent disease (absolute lymphocyte count [ALC] > 4K/uL, any lymph node > 1.5 cm by computed tomography [CT] scan, or > 30% lymphocytes on bone marrow aspirate differential). show original
The Eastern Cooperative Oncology Group (ECOG) performance status is less than or equal to 2. show original
In patients with Gilbert's disease, the total bilirubin level can be up to three times the upper limit of normal, as long as the direct bilirubin level is normal. show original
The serum creatinine level must be less than 1.5 times the upper limit of the normal range. show original
ALT and AST levels that are less than three times the upper limit of normal (unless the levels are considered to be related to the disease) are considered acceptable. show original
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-human chorionic gonadotropin [hCG]) pregnancy test result within 14 days prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 23 weeks following the last dose of the study drugs. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drugs
to their health care provider for any study-related care show original
Patients in cohort 1 have CLL or SLL, which is refractory to or has relapsed after at least one prior therapy show original
I, sinus infection, or cold Cohort 3 includes patients who have been diagnosed with a respiratory tract infection (RTI), sinus infection, or cold. show original
You must be at least 18 years old to use this service. 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: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 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 Ipilimumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of During first 21 days on study intervention.

Dose limiting toxicities
DURING FIRST 21 DAYS ON STUDY INTERVENTION
DLT is defined as clinically significant non-hematologic adverse event or abnormal laboratory value assessed as unrelated to disease, intercurrent illness, or concomitant medications and occurring during the first 21 days.
DURING FIRST 21 DAYS ON STUDY INTERVENTION
Progression-free survival
FROM TREATMENT START DATE UNTIL THE DATE OF DISEASE PROGRESSION DATE OR DEATH DUE TO ANY CAUSE, WHICHEVER OCCURRED FIRST, ASSESSED UP TO 2 YEARS
Assessed using Kaplan-Meier method.
FROM TREATMENT START DATE UNTIL THE DATE OF DISEASE PROGRESSION DATE OR DEATH DUE TO ANY CAUSE, WHICHEVER OCCURRED FIRST, ASSESSED UP TO 2 YEARS
Overall survival
FROM TREATMENT START DATE UNTIL THE DATE OF DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
Assessed using Kaplan-Meier method.
FROM TREATMENT START DATE UNTIL THE DATE OF DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
Maximum tolerated dose of ipilimumab
UP TO 2 YEARS
UP TO 2 YEARS
Overall response rate
UP TO 2 YEARS
Defined as complete response (CR) + complete response with incomplete marrow recovery (CRi) + partial response (PR). Response will be assessed by the investigator, based on physical examinations, computed tomography scans, laboratory results, and bone marrow examinations, according to the modified 2008 International Workshop on Chronic Lymphocytic Leukemia response criteria for chronic lymphocytic leukemia. The overall response rate (i.e., CR/CRi/PR) will be estimated along with the exact 95% confidence interval.
UP TO 2 YEARS
Incidence of adverse events
UP TO 2 YEARS
Will be summarized by treatment, category, severity and attribution.
UP TO 2 YEARS

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 lymphoma?

What are they~ Chemotherapy and Radiotherapy are common treatments~ There are other options such as biopsies and surgery~ My best guess is, it is not uncommon~ If your symptoms are severe or if your lymphoma comes back after treatment

Anonymous Patient Answer

What causes lymphoma?

This is a complex cancer arising from the hematopoietic system. Many types of lymphomas have identifiable oncogenic mutations in tumor suppressor genes, and a number of these are already defined as well-characterized. Inappropriate use of TNF pathway inhibitors may contribute to lymphoma risk. The genetic architecture of Hodgkin disease, and for mantle-cell lymphoma, has recently been defined. Lymphoma is characterized by a B cell neoplastic clone, which leads to a defect in the antigen receptor or its corresponding cell-surface receptor. Other alterations include a defect in one or more tumor suppressor genes, which include CDKN2, MYC, and other genes that regulate progression through the cell cycle.

Anonymous Patient Answer

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

About 100,000 people receive a diagnosis of lymphoma each year in the United States. Nearly 50,000 of them die from the disease within 5 years. Lymphoma is the second-leading cause of cancer-related death among men younger than 80.

Anonymous Patient Answer

What are the signs of lymphoma?

In the UK lymphoma is the leading cause of death in patients under the age of 50. Most cases of lymphoma are non--Hodgkin's disease and they are more common in women. The most common lymphoma in adults is lymphoma occurring mostly at an older age (mean 70 in England for lymphoma) and more commonly in men (mean 59 in England). Most individuals who develop lymphoma are asymptomatic. In England, the age-standardised rate per 100 000 population per year for all non-Hodgkin lymphoma cases is 9; and age-standardised rate for Hodgkin lymphoma is 5.

Anonymous Patient Answer

What is lymphoma?

Non-Hodgkin's lymphoma consists of two types: Diffuse large B-cell lymphoma and small lymphocytic leukemia. Non-Hodgkin's lymphoma usually starts in the elderly and generally has a poor prognosis.

Anonymous Patient Answer

Can lymphoma be cured?

The current data do not support any meaningful difference in overall or disease-free survival for men with early-stage, untreated low-grade follicular lymphoma after treatment with R-CHOP. Because high-grade follicular lymphoma is relatively chemotherapy-resistant, additional studies are needed and randomized trials should be considered when the treatment paradigm for follicular Lymphoma is being modified.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma?

The number of studies on medical treatment for lymphomas is increasing. Most studies are small, and they do not produce the results that many people would like when examining research in the area of lymphoma treatment. Many people think that there is not much difference in the treatment of lymphoma, but that can't be true. There is no consensus in regards to staging lymphoma and treatment. Therefore, people are not sure if lymphoma treatments are effective when compared to another. At this point, it is hard to find research to prove that there is not enough research to decide on what treatment is better. The field of cancer research needs high-quality research before conclusions can be made.

Anonymous Patient Answer

How does ipilimumab work?

The data suggest that combination immunotherapies do not act as monotherapy. Rather, the addition of IPIs seems to increase the clinical benefit seen with the monotherapies and is a potentially meaningful addition to current chemotherapy regimens that rely heavily on antibodies. Data from a recent study also raise the possibility that, in some cases, antibody-based combination therapies may have synergistic effects that offset some of the toxic effects of chemotherapy.

Anonymous Patient Answer

Has ipilimumab proven to be more effective than a placebo?

Ipilimumab did not demonstrate superiority over a placebo regarding PFS or OS at 4 months. This underscores the absence of a role for TGF-β inhibitors in the treatment of indolent lymphoma.

Anonymous Patient Answer

What is the latest research for lymphoma?

This topic of a lymphoma cancer book is a complex topic. All I can recommend people to do is learn everything they can and then decide if that type of learning was beneficial in their lives. It pays to listen to your doctor and read all the books out there and then discuss anything in particular with your doctor. Good reading for medical knowledge includes books on cancer like the latest Cancer Management, the latest updates in cancer research by cancer researchers, Cancer Therapy as well as medical and surgical articles by doctors and/or research nurses. For lymphoma research, books and articles about lymphoma is good as cancer is highly complex and all types of cancer are under research for treatments and cures.

Anonymous Patient Answer

What is the survival rate for lymphoma?

The overall 5-year survival rate for patients with non-Hodgkin's lymphoma is 56.8%. The rate of mortality in elderly patients is 25.6%. There is a trend towards a better survival rate for low-grade B-cell lymphomas than for high-grade B-cell lymphomas. There is a trend towards a better survival rate for non-Hodgkin's lymphoma than for Hodgkin lymphoma.

Anonymous Patient Answer

What does ipilimumab usually treat?

Ipilimumab is a medication, which has been shown to show some improvement in symptoms in patients with [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer), by decreasing estrogen. Ipilimumab is also effective in treating patients with metastatic colorectal cancer, who had previously been treated with a fluoropyrimidine agent, if those patients have a mismatch repair deficiency or deficiencies in other DNA repair enzymes. Ipilimumab is approved for use in the following cancers: melanoma, head and neck cancer, renal cell cancer and non-small cell lung cancer.

Anonymous Patient Answer
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