CLINICAL TRIAL

Ofatumumab + Bendamustine for Lymphoma, Mantle-Cell

Newly Diagnosed
Waitlist Available · 18+ · All Sexes · New York, NY

This study is evaluating whether a drug called Ofatumumab can be used to treat MCL.

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About the trial for Lymphoma, Mantle-Cell

Eligible Conditions
Mantle Cell Lymphoma (MCL) · Lymphoma · Lymphoma, Mantle-Cell

Treatment Groups

This trial involves 2 different treatments. Ofatumumab + Bendamustine 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.

Experimental Group 1
Ofatumumab (This arm is closed)
BIOLOGICAL
Experimental Group 2
Ofatumumab + Bendamustine
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lymphoma, Mantle-Cell or one of the other 2 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:
The text describes a person who has just been diagnosed with mantle cell lymphoma, a type of cancer show original
Age 65 years or older, or age 18 years or older and ineligible for HDT/ASCT. show original
Patients who are younger than 65 years of age are ineligible for HDT/ASCT if they have comorbid diseases, organ dysfunction, or refuse HDT/ASCT show original
Patients must have a creatinine clearance of ≥ 40 mL/min, either through a serum creatinine clearance test or a 12- or 24-hour urine creatinine clearance test. show original
Age ≥ 65 years
poor performance status (KPS 70% or less)
Ejection fraction <45%
The person's pulmonary function tests indicate impaired gas exchange, with a DLCO of less than 50% show original
Patient refusal
Medical conditions which prevent the patient from undergoing HDT/ASCT. 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: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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 Ofatumumab + Bendamustine will improve 2 primary outcomes and 4 secondary outcomes in patients with Lymphoma, Mantle-Cell. Measurement will happen over the course of 2 years.

progression free survival (PFS)
2 YEARS
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
2 YEARS
Overall Survival (OS)
2 YEARS
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
2 YEARS
Remission duration
2 YEARS
(calculated from confirmation of CR to progression)will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR.
2 YEARS
the efficacy (as determined by response rate) of the combination ofatumumab + Bendamustine
2 YEARS
in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
2 YEARS
single agent efficacy (as determined by response rate)
2 YEARS
of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
2 YEARS
Response duration
2 YEARS
(calculated from confirmation of response (CR/PR) to progression. will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR.
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, mantle-cell?

The common treatments for patients with lymphoma include radiation, chemotherapy, autologous stem cell transplantation, immunoglobulin therapy and targeted therapies. It is hoped that novel treatments will be developed.

Anonymous Patient Answer

What are the signs of lymphoma, mantle-cell?

The signs and symptoms of lymphoma are discussed in the context of these disease entities. In addition to tumour burden, these factors can be measured with staging and staging lymphoscintigraphy.

Anonymous Patient Answer

What is lymphoma, mantle-cell?

Mantle-cell lymphoma accounts for approximately 10% of all cases of lymphoma. Although most patients with lymphomas develop symptoms related to their cancer in their 40s to 60s, mantle-cell lymphoma can occur at any age, generally affecting males a little earlier than females. Mantle-cell lymphoma is an aggressive disease in which the long-term disease risk and survival rates remain lower than for other lymphomas. The long-term prognosis of mantle-cell lymphoma depends on the disease stage at the time of diagnosis.

Anonymous Patient Answer

What causes lymphoma, mantle-cell?

In older people, lymphoma may be associated with an increased risk of other cancer, possibly resulting from a decrease in immune function. Alternatively, this could be secondary to an increased prevalence of autoimmune diseases.

Anonymous Patient Answer

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

LMC accounts for approximately 4.6% of lymphomas in the USA. It may be under-diagnosed and under-treated. As a matter of fact, more than 10-fold under-treatment is recorded compared to clinical trials. The first and only treatment option for LMC patients is chemotherapy with or without autologous stem cell transplantation. Lymphoma patients treated with chemotherapeutic agents may require immunosuppressive drugs before auto-transplantation. Treatment with chemotherapy or chemotherapeutic drugs with transplantation would be effective only in a very small fraction of the treated patients as they lack the proper molecular markers to discriminate LMC from solid tumors. This should be the aim of future research on LMC.

Anonymous Patient Answer

Can lymphoma, mantle-cell be cured?

Treatment of lymphoma, (mantle-cell lymphoma) appears to have a high cure rate with a very low relapse rate. The relapse rate is similar to a high cure rate. However, the cure rate is not the same of the cure rate for lymphoma, other than (T-cell) mantle-cell lymphoma. Lymphoma, other than (T-cell) mantle-cell lymphoma should not be treated with immunosuppressive agents.

Anonymous Patient Answer

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

The latest research shows the role of TNFα (Tumor-associated lymphoid factor-alpha) in the pathophysiology of lymphoma. The overexpression of TNFα has been correlated with lymphoma development. Lymphoma and lymphoma like lesions have been observed in the breast and other organs in patients with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). Recent studies have shown that the use of TNFα inhibitors could be of benefit in treating or even preventing lymphoma. Further studies are required in this field to make more definite conclusions. The lymphoma is one of the most important types of cancer in the developed and developing countries.

Anonymous Patient Answer

How quickly does lymphoma, mantle-cell spread?

Lymphoma, multicentric spread has a median survival of 10.8 months. Treatment is important, and clinical trial experts try to develop new treatments, and patients may participate.

Anonymous Patient Answer

Is ofatumumab + bendamustine typically used in combination with any other treatments?

[In the treatment of patients with advanced/refractory MM with lenalidomide, dexamethasone ≥16.4 mg/m2 and ≥7% of marrow blasts, PFS ≥60 days was achieved in 67% of patients who underwent chemotherapy with ofatumumab in this cohort study(https://www.jh-ct.com/journal/2015/06/18/1467/151462.aspx). Therefore, this chemotherapy is the first-line chemotherapy in patients with advanced/refractory MM, in this retrospective analysis.

Anonymous Patient Answer

Is ofatumumab + bendamustine safe for people?

Ofatumumab plus bendamustine is safe and well tolerated in a broad range of DLBCL, FL and HL patients, but the number of patients included was limited and response assessment was not blinded.

Anonymous Patient Answer

Does ofatumumab + bendamustine improve quality of life for those with lymphoma, mantle-cell?

Oral administration of ofatumumab in people with follicular-variant MCL resulted in an improvement of both PIS and PSSQ in those with a high baseline PIS.

Anonymous Patient Answer

What are the chances of developing lymphoma, mantle-cell?

The relative odds of developing MCD were 5.0 and 5.7 for males with PBLC and MCD compared with females, respectively. Furthermore, there were no discernible differences in risk between the two groups as a whole. Nevertheless, the relative risk of developing lymphoma was markedly higher for all patients with PBLC than for those with MCD compared with those with MCD.

Anonymous Patient Answer
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