CLINICAL TRIAL

Venetoclax for Lymphoma, B-Cell

Recruiting · 18+ · All Sexes · Bethesda, MD

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

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About the trial for Lymphoma, B-Cell

Eligible Conditions
Diffuse Large B-Cell Lymphoma (DLBCL) · Lymphoma, Large B-Cell, Diffuse · Lymphoma, B-Cell · Non-Hodgkin's Lymphoma (NHL) · Burkitt Lymphoma · Lymphoma

Treatment Groups

This trial involves 6 different treatments. Venetoclax is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Obinutuzumab
BIOLOGICAL
+
Revlimid (lenalidomide)
DRUG
+
Ibrutinib
DRUG
+
Prednisone
DRUG
+
Venetoclax
DRUG
Experimental Group 2
Obinutuzumab
BIOLOGICAL
+
Revlimid (lenalidomide)
DRUG
+
Ibrutinib
DRUG
+
Prednisone
DRUG
+
Venetoclax
DRUG
Experimental Group 3
Obinutuzumab
BIOLOGICAL
+
Revlimid (lenalidomide)
DRUG
+
Ibrutinib
DRUG
+
Prednisone
DRUG
+
Venetoclax
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Lenalidomide
FDA approved
Ibrutinib
FDA approved
Prednisone
FDA approved
Venetoclax
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, B-Cell or one of the other 5 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:
NOTE: Patients with known active CNS lymphoma are not eligible.
Phase1b
Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).
CLL/SLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL/SLL compared to other non-Hodgkin lymphomas.
Phase 2
Relapsed and/or refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).
Indolent B-cell lymphoma: relapsed after and/or refractory to at least 1 prior anti-CD20 antibodyRituximab-containing regimen.
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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: Time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time from the date of from initial diagnosis until death from any cause; assessed every 3-6 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 Venetoclax will improve 1 primary outcome and 3 secondary outcomes in patients with Lymphoma, B-Cell. Measurement will happen over the course of 22 days.

Number and grade of adverse events
22 DAYS
Number and grade of adverse events
Overall response rate (ORR)
TIME MEASUREMENT CRITERIA ARE MET FOR CR OR PR (WHICHEVER IS FIRST RECORDED) UNTIL THE FIRST DATE THAT RECURRENT OR PROGRESSIVE DISEASE IS OBJECTIVELY DOCUMENTED OR DEATH, ASSESSED EVERY 3-6 MONTHS
Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed every 3-6 months
Progression-free survival (PFS)
TIME FROM THE DATE OF STUDY ENROLLMENT UNTIL TIME OF DISEASE RELAPSE, DISEASE PROGRESSION, OR DEATH, WHICHEVER OCCURS FIRST, ASSESSED EVERY 3-6 MONTHS
Time from the date of study enrollment until the time of disease relapse, disease progression, or death, whichever occurs first, assessed every 3-6 months
Overall survival (OS)
TIME FROM THE DATE OF FROM INITIAL DIAGNOSIS UNTIL DEATH FROM ANY CAUSE; ASSESSED EVERY 3-6 MONTHS
Time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can lymphoma, b-cell be cured?

Lymphoma is not curable. However, due to improvements in treatment, patients are probably benefiting from their lymphomas. As the disease progresses, the chances of cure decrease.

Anonymous Patient Answer

What are common treatments for lymphoma, b-cell?

Standard chemotherapy for solid tumors and aggressive chemotherapy regimens may be used as a general standard treatment, although results are usually worse than those obtained with the standard chemotherapy regimen alone. Radiation therapy and targeted agents may be used in addition to chemotherapy to augment treatment, although results are also worse than with chemotherapy alone. The best results are often obtained when treatments used at other sites are combined with chemotherapy. In addition to these conventional treatments, the use of immunotherapy has resulted in good clinical results when combined with conventional therapies.

Anonymous Patient Answer

What causes lymphoma, b-cell?

Immunocompromised patients do not have a higher risk of B-cell lymphoma as compared to immunocompetent patients. Conversely, the disease is rare in immunocompetent subjects under the age of 20 years old, but increased from age 40 years onwards.

Anonymous Patient Answer

What are the signs of lymphoma, b-cell?

B-cell lymphoma manifests as a slow decline in lymph node function or mass (a'slowly progressive disease'). A fastly progressive disease course, for example, in the context of [acute lymphoblastic leukemia](https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia) or other leukemias, will also indicate this diagnosis. In both case scenarios, imaging is helpful if the cause of the persistent lymphadenopathy remains unclear. In lymphoma, specific imaging techniques such as positron emission tomography for Hodgkin's disease and single-photon emission computed tomography for diffuse large B-cell lymphoma will detect disease activity.

Anonymous Patient Answer

What is lymphoma, b-cell?

While lymphoma is a disease that forms malignant tumors in the lymphatic system, it is a very heterogeneous disease with no general diagnostic standard. As a result, there are many subtypes that have different clinical and histopathological characteristics but the same disease biology.\n

Anonymous Patient Answer

How many people get lymphoma, b-cell a year in the United States?

Around 32,000, 13,000, 6,950, 4,280, 3,260 and 3,260 people in the United States are believed to get lymphoma, B-cell, follicular, mantle zone-cell, Burkitt, and B-cell, Hodgkin/Reed/Richardson-Siemsek B, subtypes, a year, respectively.

Anonymous Patient Answer

What are the common side effects of venetoclax?

For patients receiving venetoclax, the vast majority of respondents (96% of respondents) experienced adverse events ranging from mild-moderate to moderate or severe (that caused them to stop or change drug). These events were predominantly local or gastrointestinal but also included hematological, skin, or central nervous system side effects.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma, b-cell?

New drugs have been in development for many years, and many of them are being used to treat lymphoma, b-cell. Still, patients with an aggressive type of lymphoma, like DLBCL, continue to resist effective treatment. The discovery that B7-H3 might be useful in lymphoma may present the chance for the creation of new treatment strategies for these malignancies.

Anonymous Patient Answer

What is the latest research for lymphoma, b-cell?

Recent research is mainly focussing on developing effective chemotherapy treatments. There are also trials looking for immunotherapeutic treatments and targeted therapies for lymphoma. There have also been trials for other types of tumours such as brain tumours, [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer)s, lung cancers, liver cancers, and others. These are being used to investigate possible effective treatments. There are some treatments and therapies for other cancers in the early stages of research or are being used to increase our understanding of lymphoma. Because these cancers usually affect adults and it is hard to find statistics for lymphoma in small children, it is difficult to find out whether or not the amount of research on this type of cancer is low and could become an important health care issue.

Anonymous Patient Answer

What are the latest developments in venetoclax for therapeutic use?

Recent advances in understanding the molecular basis of B-cell malignancies have brought about the development of new therapeutic approaches. In particular studies have highlighted the importance of TNF-R1 inhibition for the treatment of lymphomas and other B-cell malignancies. On this basis, recent clinical trials have focused on the optimization of venetoclax doses, pharmacokinetics and the evaluation of novel combinations for therapeutic use as well as for testing antitumor activity and other immunomodulatory properties. The drug's role as a key component of B-cell malignancy treatment is further highlighted by the development of a clinical trial for venetoclax as a single agent treatment in patients with relapsed chronic lymphocytic leukemia.

Anonymous Patient Answer

Is venetoclax safe for people?

In this phase III clinical trial of people with early follicular or advanced follicular non-Hodgkin's lymphoma, venetoclax met its primary analysis endpoints. Venetoclax was generally well tolerable, but its side effects were more frequent in the older populations. Longer periods and higher doses of interstitial fluid were associated with an increased risk of serious venetoclax-related adverse events.

Anonymous Patient Answer

What does venetoclax usually treat?

Clinical responses were observed in patients with lymphomas as well as other malignancies. This suggests that venetoclax has the ability to produce responses in some hematopoietic cancers. Some of these observations in patients may indicate that venetoclax will be effective in other types of cancer because of its ability to impact the function of hematopoietic cells in the body.

Anonymous Patient Answer
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