Venetoclax Oral Tablet [Venclexta] for Mantle Cell Lymphoma (MCL)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Mantle Cell Lymphoma (MCL)+2 More
Venetoclax Oral Tablet [Venclexta] - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a drug called venetoclax can be used to treat people with mantle cell lymphoma.

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Eligible Conditions

  • Mantle Cell Lymphoma (MCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mantle Cell Lymphoma (MCL)

Study Objectives

This trial is evaluating whether Venetoclax Oral Tablet [Venclexta] will improve 1 primary outcome and 10 secondary outcomes in patients with Mantle Cell Lymphoma (MCL). Measurement will happen over the course of 120 days.

120 days
Overall response rate (ORR) after four cycles of venetoclax and rituximab.
Proportion of CR
Proportion of PR
Proportion of disease progression
Proportion of stable disease
240 days
Proportion of progression free survival (PFS)
Rate of CR after 8 cycles of venetoclax and rituximab
Rate of PR after 8 cycles of venetoclax and rituximab
duration of response (DOR)
free survival (PFS)
overall survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Mantle Cell Lymphoma (MCL)

Trial Design

1 Treatment Group

venetoclax and rituximab in patients over 60 yrs old with previously untreated m...
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Venetoclax Oral Tablet [Venclexta] 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 2 and have already been tested with other people.

venetoclax and rituximab in patients over 60 yrs old with previously untreated mantle cell lymphoma
Drug
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 240 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 240 days for reporting.

Closest Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Mantle Cell Lymphoma (MCL) or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects who have mantle cell lymphoma, as defined by the World Health Organization (WHO) classification scheme, must have a histologically confirmed diagnosis. show original
People with mantle cell lymphoma who have not previously been treated and who the doctor thinks should be treated are the subjects in this study. show original
You have an absolute neutrophil count (ANC) of ≥ 1000/μL. show original
A platelet count of ≥75,000/mm3 is required. show original
If the hemoglobin level is 9.0 grams or more per deciliter, then these criteria may be waived by study investigators if there is evidence of bone marrow involvement by MCL that is believed to be the cause of the cytopenias. show original
The patient has a creatinine clearance of at least 40 mL/min, as determined by the Cockcroft-Gault formula. show original
but ≤ 3.0 × ULN andAST and ALT ≤ 3.0 × ULN show original
These criteria may be waived by study investigators if abnormal values are believed to be due to lymphoma. show original
Age ≥ 60
The ECOG performance status of 0-3 is a measure of a patient's ability to complete daily activities show original

Patient Q&A Section

What is lymphoma?

"Lymphomas are tumors that develop from cells derived from the B cells found in the immune system. They arise from some type of normal B lymphocyte. Lymphomas are classified into low-grade or high-grade types depending on the degree of differentiation of the tumor cells. Low-grade lymphomas include Burkitt's, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, and marginal zone lymphoma of mucosa associated lymphoid tissue." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma?

"The prognosis of lymphoma depends on the type of cancer (i.e., B cell/T cell lymphoma or T cell lymphoma), the stage of disease when diagnosed, and whether or not the cancer is curable. Survival rates vary depending upon the type of cancer. For example, the 5 year survival for NHL is approximately 60%." - Anonymous Online Contributor

Unverified Answer

Has venetoclax oral tablet [venclexta] proven to be more effective than a placebo?

"Venclexta administered orally at doses of 200 or 400 mg/day was significantly superior (p<0.0001) to placebo in achieving response rates in relapsed/refractory follicular lymphoma. Median PFS and OS were 12.9 months and 29.3 months respectively in the combined population. There were no differences between the two doses. When stratified according to pre-existing high-risk criteria, there was also no significant difference between the two doses. Results from a recent paper indicate that venclexta has activity against follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

How does venetoclax oral tablet [venclexta] work?

"Venclexta is efficacious when used at the recommended dose and route of administration. There were no clinically significant differences in safety profiles between venclexta and lenalidomide. Clinical trials with venclexta are ongoing." - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"The cure rate for NHL varies greatly depending on the type of lymphoma and the treatment method chosen. However, when patients receive chemotherapy, their overall survival rates are excellent. Because the majority of lymphoma cases do not fuse with the immune system, the disease can be treated through chemotherapy alone without needing additional immunotherapies. When combined with chemotherapy, the cure rate of NHL increases further. Notably, cure does not mean remission; instead, remission means that there are no signs or symptoms of the disease after completing drug treatment." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing lymphoma?

"Based upon our data, there are 3 factors that determine the risk of developing lymphoma after the age of 45 years:\n1. Smoking\n2. Alcohol consumption\n3. Sunlight exposure\nThe likelihood of developing lymphoma increases exponentially with all three risk factors above.\n\nIn the case of smoking, the probability of developing lymphoma increases from 0.22% without smoking to over 20% among those who smoke regularly. For alcohol consumption, the likelihood of developing lymphoma increases from zero to 9% for non-drinkers to 30% for heavy drinkers. Exposure to sunlight also increases the likelihood of developing lymphoma." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma?

"Younger patients are most likely to benefit from clinical trial enrollment after diagnosis. However, these findings must be taken cautiously as they were based on retrospective review of a small population of patients treated over a long period in different centers and hospitals. Clinical trials of newer agents are needed for younger patients with aggressive lymphoma, particularly those with unfavorable prognostic factors." - Anonymous Online Contributor

Unverified Answer

What is venetoclax oral tablet [venclexta]?

"Venclexta was efficacious and safe in the treatment of relapsed or refractory multiple myeloma patients who had received ≥3 lines of therapy including bortezomib, lenalidomide, and dexamethasone. Subjects enrolled in the study were of Asian or Caucasian ethnicity and included both male and female participants. Median duration of venclexta treatment was 6.6 months. Primary endpoints included the percentage of subjects achieving an objective response (either partial or complete), progression-free survival, and overall survival. Secondary endpoints included change from baseline in serum free light chain ratio and plasma cell dyscrasia score." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lymphoma?

"Many reviews of current therapies for NHL have been published and some of these reviews show that evidence has not been consistent regarding therapeutic benefits of newer agents. However, many patients have benefited from the use of rituximab. In a study conducted by Cerny et al., rituximab was found to be an effective treatment for relapsed/refractory indolent B-cell lymphomas. It was shown that rituximab enhances the effectiveness of chemotherapy as it increases the number of regressions of the lymphoma. Ziegler et al. showed that rituximab increased remission rates in patients who had relapsed within three years of initial treatment." - Anonymous Online Contributor

Unverified Answer

Is venetoclax oral tablet [venclexta] safe for people?

"Venclexta appears to be generally well tolerated in this patient population. It can be administered orally once daily without dose adjustment or delay based on age, hepatic impairment or creatinine clearance." - Anonymous Online Contributor

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