CLINICAL TRIAL

Cisplatin for Lymphoma, B-Cell

1 Prior Treatment
Recurrent
Refractory
Recruiting · 18+ · All Sexes · Iowa City, IA

This study is evaluating whether a combination of chemotherapy and vitamin C may be more effective at treating lymphoma.

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About the trial for Lymphoma, B-Cell

Eligible Conditions
Recurrent Lymphoma · Lymphoma, Large B-Cell, Diffuse · Lymphoma · Lymphoma, B-Cell · Refractory Lymphomas · Recurrent Hodgkin Lymphoma · Clonal Cytopenia of Undetermined Significance · Refractory Diffuse Large B Cell Lymphoma (DLBCL) · Recurrent Diffuse Large B-Cell Lymphoma · High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements

Treatment Groups

This trial involves 4 different treatments. Cisplatin is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Cisplatin
DRUG
+
Dexamethasone
DRUG
+
Ifosfamide
DRUG
+
Cytarabine
DRUG
+
Laboratory Biomarker Analysis
OTHER
+
Oxaliplatin
DRUG
+
Ascorbic Acid
DIETARYSUPPLEMENT
+
Carboplatin
DRUG
+
Gemcitabine Hydrochloride
DRUG
+
Etoposide
DRUG
+
Questionnaire Administration
OTHER
Experimental Group 2
Cisplatin
DRUG
+
Dexamethasone
DRUG
+
Ifosfamide
DRUG
+
Cytarabine
DRUG
+
Laboratory Biomarker Analysis
OTHER
+
Rituximab
BIOLOGICAL
+
Ascorbic Acid
DIETARYSUPPLEMENT
+
Carboplatin
DRUG
+
Etoposide
DRUG
+
Questionnaire Administration
OTHER
Experimental Group 3
Laboratory Biomarker Analysis
OTHER
+
Ascorbic Acid
DIETARYSUPPLEMENT
+
Questionnaire Administration
OTHER
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
Dexamethasone
FDA approved
Ifosfamide
FDA approved
Cytarabine
FDA approved
Oxaliplatin
FDA approved
Rituximab
FDA approved
Ascorbic Acid
2017
Completed Phase 4
~2350
Carboplatin
FDA approved
Gemcitabine
FDA approved
Beta-D-Glucose
Not yet 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 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:
NOTE: Arm C patients include relapsed lymphoma patients of any type for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed double-hit high grade lymphoma patients and relapsed Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without responding
Measurable or assessable disease: measurable disease is defined as measurable by computed tomography (CT) (dedicated CT or the CT portion of a positron emission tomography [PET]/CT) or magnetic resonance imaging (MRI): to be considered measurable, there must be at least one lesion that has a single diameter of >= 1.5 cm
NOTE: Skin lesions can be used if the area is >= 1.5 cm in at least one diameter and photographed with a ruler; patients with assessable disease by PET are also eligible as long as the assessable disease is biopsy proven lymphoma
Arms A/B - eligible for treatment with ifosfamide, carboplatin, and etoposide (+/- rituximab)
Ifosfamide/carboplatin/etoposide (ICE) or rituximab/ifosfamide/carboplatin/etoposide (RICE);
Cisplatin, cytarabine (cytosine arabinoside), dexamethasone (DHAP) or RDHAP;
Biopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted > 6 months; refractory is no response or relapse within 6 months; previous biopsies < 6 months prior to treatment on this protocol will be acceptable
NOTE: Arms A/B - relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse
Gemcitabine hydrochloride (gemcitabine), dexamethasone, cisplatin (GDP) or rituximab, gemcitabine, dexamethasone, cisplatin (RGDP);
Gemcitabine and oxaliplatin (GemOx) or rituximab, gemcitabine and oxaliplatin (RGemOx);
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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 Cisplatin will improve 3 primary outcomes, 7 secondary outcomes, and 4 other outcomes in patients with Lymphoma, B-Cell. Measurement will happen over the course of At 20 weeks.

Hematologic response (HI) rate (Arm D)
AT 20 WEEKS
Defined as an objective status of HI-E (minor or major response), HI-P, or HI-N evaluated by Myelodysplastic Syndrome International Working Group 2018 criteria at 20 weeks. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm.
AT 20 WEEKS
TET2 activity (Arm D)
AT BASELINE AND WEEKS 12, 20, 52
Values will be summarized graphically and descriptively at each time point and changes across time will be explored.
AT BASELINE AND WEEKS 12, 20, 52
Progression-free survival
FROM DATE OF FIRST TREATMENT TO THE EARLIEST DATE OF DOCUMENTATION OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
The distribution of progression-free survival will be estimated in each arm using the method of Kaplan-Meier. In the DLBCL arms, the comparison of progression-free survival between the two treatment arms will be based on the log-rank test.
FROM DATE OF FIRST TREATMENT TO THE EARLIEST DATE OF DOCUMENTATION OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
Overall survival
FROM REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
The distribution of overall survival will be estimated in each arm using the method of Kaplan-Meier. In the DLBCL arms, the comparison of overall survival between the two treatment arms will be based on the log-rank test.
FROM REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
Biomarker analysis (Arm D)
BASELINE UP TO 2 YEARS
Variant allele frequency (VAF), biomarkers levels from Olink study, values of the cytokines, endothelial dysfunction, inflammation markers and levels of 5mc/5hmc will be measured at baseline, after completion of treatment (at 20 weeks), and at one-year post-registration. Values will be summarized graphically and descriptively at each time point and changes across time will be explored. Due to small sample size, these correlative analyses will be considered exploratory.
BASELINE UP TO 2 YEARS
Biomarker analysis on blood and tissue (Arms A, B, and C)
BASELINE UP TO 2 YEARS
Will consider the correlative research exploratory.
BASELINE UP TO 2 YEARS
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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.

What is the average age someone gets lymphoma, b-cell?

Lymphomas are a disease of the older population of patients. Because lymphoma accounts for 15% of all cancers, it is important that lymphoma is taken into consideration among all malignancies.

Anonymous Patient Answer

What are the signs of lymphoma, b-cell?

Features of lymphoma that can be confused with those of infectious complications of cancer, such as fevers and weight loss, are uncommon. An individual's signs and symptoms may reveal the diagnosis of a specific subtype of lymphoma or prompt additional testing.

Anonymous Patient Answer

What is lymphoma, b-cell?

Lymphoma refers to a group of blood cancers of which lymphomas are included. There are many types of lymphoma with diverse causes, most commonly related to immunosuppression, such as AIDS, and chronic infectious autoimmune disease, including chronic infection with Epstein-Barr virus (monoclonal or polyclonal), and with chronic cytomegalovirus. The number of new cancers diagnosed annually in the United States and in Europe is increasing.

Anonymous Patient Answer

Does etoposide improve quality of life for those with lymphoma, b-cell?

The B-cell lymphoma patients treated with etoposide exhibited improved quality of life after 3+4 cycles of chemotherapy. The increased quality of life was associated with the improvement in symptoms such as fatigue and bone pain.

Anonymous Patient Answer

What are common treatments for lymphoma, b-cell?

B-cell lymphoma arises most commonly in elderly individuals. Treatments include chemotherapy. Radiation and/or surgery may be used in aggressive cases. A small number of cases will also respond to targeted therapy. Lymphoma involving different B-cell subsets have different types of treatments and prognoses.

Anonymous Patient Answer

What causes lymphoma, b-cell?

It is difficult to study lymphoma causation, but we do know a few factors that might help: it's [likely] a heterogenous disorder, it [most] may be due to genetic susceptibility, it's [highly] [likely] [neural] and immune function are altered (neuroimmune hypothesis), it [most] may be a [neoplastic, and not immune-mediated, disease]\n

Anonymous Patient Answer

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

Probably around 8,000 new cases of this type of cancer are diagnosed each year in America. It is the most common type of cancer in young men.

Anonymous Patient Answer

Can lymphoma, b-cell be cured?

Current treatment can cure many lymphomas, including hairy cell leukemia, lymphoma in the elderly, and multiple myeloma. Patients with stage IV hairy cell leukemia have an overall 5-year survival of 76%.

Anonymous Patient Answer

How quickly does lymphoma, b-cell spread?

To avoid late chemotherapy/radiotherapy toxicity to the lungs and other organs after chemotherapy, lymphocyte count reduction should be done within the first two weeks of therapy. In a recent study, findings also demonstrate the need for routine pulmonary functions tests before chemotherapy starts.

Anonymous Patient Answer

Who should consider clinical trials for lymphoma, b-cell?

Clinical trials of lymphoma, b-cell may improve survival after chemotherapy, but the risk for progression of the cancer is high. Most patients participating in clinical trials for lymphoma, b-cell experience both benefits and risks.

Anonymous Patient Answer

Has etoposide proven to be more effective than a placebo?

The primary endpoint showed that etoposide is more effective in reducing the progression rate with the treatment compared to placebo. Etoposide, as single agent therapy, can lower the progression rate as well as the overall mortality rate in patients suffering from NHL.

Anonymous Patient Answer

Is etoposide typically used in combination with any other treatments?

The incorporation of Etoposide into the management, especially of patients with a poor prognosis, can provide significant benefit. Given the adverse effect profile seen in the use of this agent, this has become the most common scenario.

Anonymous Patient Answer
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