CLINICAL TRIAL

Cytarabine for Lymphoma, Mantle-Cell

Grade III
Newly Diagnosed
Standard Risk
Recruiting · 18+ · All Sexes · Cape Girardeau, MO

This study is evaluating whether a combination of chemotherapy drugs and a drug that blocks enzymes may help treat mantle cell lymphoma.

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About the trial for Lymphoma, Mantle-Cell

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

Treatment Groups

This trial involves 3 different treatments. Cytarabine is the primary treatment being studied. Participants will be divided into 3 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
Bendamustine
DRUG
+
Acalabrutinib
DRUG
+
Bendamustine Hydrochloride
DRUG
+
Rituximab
BIOLOGICAL
Experimental Group 2
Cytarabine
DRUG
+
Bendamustine
DRUG
+
Bendamustine Hydrochloride
DRUG
+
Rituximab
BIOLOGICAL
Experimental Group 3
Cytarabine
DRUG
+
Bendamustine
DRUG
+
Acalabrutinib
DRUG
+
Bendamustine Hydrochloride
DRUG
+
Rituximab
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Bendamustine
FDA approved
Tyrosine
FDA approved
Bendamustine
FDA approved
Rituximab
FDA approved

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 3 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 baseline measurements and evaluations for a study must be obtained within 6 weeks of when the person was randomly chosen to participate in the study show original
People being treated with gastric reducing agents, proton pump inhibitors, must switch to a different drug before starting acalabrutinib. show original
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 in order to be eligible for this study. show original
Patients must have mantle cell lymphoma, which is a cancer of the lymphatic system show original
The patient's bilirubin level is below the institutional threshold for unacceptable levels. show original
AST/ALT =< 5 x institutional ULN
OPEN requires that you calculate your MIPI score and enter it into the system. show original
The ANC is greater than or equal to 500/mcL. show original
Platelets >= 25,000/mcL
Patients with prothrombin time (PT) or partial thromboplastin time (aPTT) below 2 times the institutional upper limit of normal (obtained within 14 days of randomization) are eligible for this study, except those taking anticoagulant therapy (other than warfarin or equivalent vitamin K antagonists, which are excluded) 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 10 years post randomization
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 10 years post randomization
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 10 years post randomization.
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 Cytarabine will improve 1 primary outcome, 5 secondary outcomes, and 8 other outcomes in patients with Lymphoma, Mantle-Cell. Measurement will happen over the course of Up to 8 weeks post treatment.

Composite of positron emission tomography (PET)/computed tomography (CT) complete response (CR) and peripheral blood (PB) minimal residual disease (MRD) negative rate
UP TO 8 WEEKS POST TREATMENT
MRD status is defined as positive, negative, or indeterminate as measured from PB specimens following completion of treatment. Measures of frequencies and proportion, and location and dispersion will be used to describe categorical, and continuous variables respectively; 90% confidence intervals around these estimates will be computed. Kaplan-Meier method will be used to describe time-to-event endpoints and log-rank test to assess difference in time-to-event endpoints by levels of a categorical predictor. Cox proportional hazards (PH) regression model would be used to model the impact of baseline and other relevant variables on time-to-event endpoints.
UP TO 8 WEEKS POST TREATMENT
Progression-free survival (PFS)
FROM RANDOMIZATION TO EARLIEST OF DISEASE PROGRESSION OR DEATH, ASSESSED AT 36 MONTHS
FROM RANDOMIZATION TO EARLIEST OF DISEASE PROGRESSION OR DEATH, ASSESSED AT 36 MONTHS
Overall survival (OS)
FROM RANDOMIZATION TO DEATH, ASSESSED AT 36 MONTHS
Patients that are alive will be censored at the time of last follow-up. OS will be described using the Kaplan-Meier method and log-rank test will be used to compare survival by treatment arm.
FROM RANDOMIZATION TO DEATH, ASSESSED AT 36 MONTHS
Incremental prognostic value of interim qPET to standard risk markers (MIPI)
AT END OF TREATMENT (WITHIN 6 MONTHS AFTER THE "8 WEEKS POST TREATMENT" TIMEFRAME)
Will assess the incremental prognostic value of interim qPET to standard risk markers (MIPI) in predicting MRD status.
AT END OF TREATMENT (WITHIN 6 MONTHS AFTER THE "8 WEEKS POST TREATMENT" TIMEFRAME)
Interim PET status
AT END OF TREATMENT (WITHIN 6 MONTHS AFTER THE "8 WEEKS POST TREATMENT" TIMEFRAME)
Interim PET status both qualitatively (Deauville) and quantitatively will be correlated with MRD status. Will fit a logistic regression model to evaluate this aim with binary MRD status at end of treatment (EOT) as the response variable and interim PET status as the predictor.
AT END OF TREATMENT (WITHIN 6 MONTHS AFTER THE "8 WEEKS POST TREATMENT" TIMEFRAME)
Incremental prognostic value of interim qPET to Ki67
AT END OF TREATMENT (WITHIN 6 MONTHS AFTER THE "8 WEEKS POST TREATMENT" TIMEFRAME)
Will assess the incremental prognostic value of interim qPET to Ki67 in predicting MRD status.
AT END OF TREATMENT (WITHIN 6 MONTHS AFTER THE "8 WEEKS POST TREATMENT" TIMEFRAME)
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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.

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

Results from a recent paper confirms the need for high-quality epidemiological analyses in cancer registries to develop and validate risk-adjusted staging and therapy outcome analyses and to understand the nature of the variation in cancer survival in different ethnic groups. The need to identify the causes of the observed variation in cancer survival among different ethnic groups is paramount.

Anonymous Patient Answer

Can lymphoma, mantle-cell be cured?

Lymphoma is not curable. However, some people with mantle-cell lymphoma may be able to be cured. A curative strategy may be attempted if there is no evidence of disease in other organs. If the disease has spread to the bone marrow, the disease can be fatal or progressive, which must be kept in mind when considering treatment options.

Anonymous Patient Answer

What are common treatments for lymphoma, mantle-cell?

Lymphomas are usually treated with anticancer agents such as cyclophosphamide, procarbazine and doxorubicin in combination with chemotherapy. Radiation and/or surgery may also be administered to shrink the tumor or to remove it entirely. Lymphomas respond well to combination chemotherapy. Targeted biologic agents are an evolving field. The best way to manage lymphomas in young adult patients is not clear, as survival rates are about the same as those for younger adults with Hodgkin disease. Because lymphomas cause such a wide variety of symptoms, it is important to get a complete physical and cognitive evaluation to rule out complications of the disease.

Anonymous Patient Answer

What are the signs of lymphoma, mantle-cell?

Symptoms associated with skin lesions and lymphadenopathy include the enlargement of a lymph node and skin rash. Other symptoms of lymphoma include unintentional weight loss, fatigue, night sweats, fever and loss of appetite.

Anonymous Patient Answer

What is lymphoma, mantle-cell?

Lymphoma accounts for 5% of the cancer burden worldwide, and it is common in North America, especially for men. Most lymphomas are lymphomas of childhood or adolescence. T-cell lymphoma represents 50% of the cases in those of reproductive age and a quarter of the cases in older men and women, with a peak incidence for patients 30 to 60 years of age. Lymphomas of bone (lymphomas of the skeletal system) represent an annual incidence of approximately 1.2 cases per 100,000 per year, and primary lung lymphomas number at least 1,900 each year (accounting for approximately 1.1 of 1,000 cases of lung cancer).

Anonymous Patient Answer

What causes lymphoma, mantle-cell?

It is not clear why mantle-cell lymphoma is the type of lymphoma seen most frequently in this study. However, two factors may contribute: (1) some infections are risk factors and (2) there is a defect in the ability of lymphocytes in mantle-cell lymphoma to destroy malignant cells.

Anonymous Patient Answer

Does cytarabine improve quality of life for those with lymphoma, mantle-cell?

After 2 cycles of cytarabine, a significant effect on HRQOL was observed, and by the end of the first cycle, 82% were classified as'very much better' and 12% as'much better' or 'better'. Cytarabine appears to be an effective treatment for lymphoma in children.

Anonymous Patient Answer

What is cytarabine?

Cytarabine is a cancer treatment agent used to treat lymphomas and acute leukemias. This drug can help treat leukemia by stopping the development of cancer cells. On the other hand, when taken by mouth it can result in gastrointestinal side effects. You can find the most recent cytarabine clinical trials by using Power.

Anonymous Patient Answer

Has cytarabine proven to be more effective than a placebo?

Cytarabine is more effective in treating patients with MM compared to a placebo. It is thus considered as being safe and well tolerated, and the therapy can be conducted safely in both the initial phase of the treatment as well as later relapse.

Anonymous Patient Answer

What is the primary cause of lymphoma, mantle-cell?

Primary (in immunocompetent individuals) mantle-cell lymphoma accounts for about 25% of newly diagnosed cases. Secondary lymphomas (in immunocompromised individuals) make up the remaining 75%. The primary (or common cause) of nodular lymphocyte predominant Hodgkin's disease remains undefined, but evidence suggests that this lymphatic disorder represents a disease spectrum ranging from a self-limited chronic condition in older immunocompetent individuals (or, perhaps, an opportunistic disease in immunocompromised individuals) to a severe and life-threatening disorder in immunocompromised individuals, and possibly in immunodeficiency.

Anonymous Patient Answer

What are the latest developments in cytarabine for therapeutic use?

Today's standard regimes provide modest clinical benefits, but the data reviewed provide further evidence that the drug deserves more attention. More comprehensive studies are required to explore the use of a higher dose or schedule, to investigate other mechanisms of action for cytarabine and related chemotherapeutics, and to investigate the effect of combination regimens.

Anonymous Patient Answer

Does lymphoma, mantle-cell run in families?

The present study is the first to report a higher incidence of both MCL and non-ATLL M2 AL in a kindred with this disease. This finding suggests a possible genetic predisposition in MCL families.

Anonymous Patient Answer
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