Rituximab for Clonal Cytopenia

Mayo Clinic Health System-Franciscan Healthcare, La Crosse, WI
Clonal Cytopenia+6 More ConditionsRituximab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying ascorbic acid combined with chemo to treat lymphoma that has returned or is unresponsive to therapy. Ascorbic acid may make cancer cells more sensitive to chemo.

Eligible Conditions
  • Clonal Cytopenia of Undetermined Significance
  • Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Refractory Lymphomas
  • Recurrent Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Omeprazole
1
GROUP D2 ARM CE
1
rituximab and lenalidomide

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Up to 2 years

At 20 weeks
Hematologic response (HI) rate (Arm D)
Week 12
TET2 activity (Arm D)
Year 2
Biomarker analysis (Arm D)
Biomarker analysis on blood and tissue (Arms A, B, and C)
Year 2
Progression-free survival
Year 2
Overall survival
Up to 2 years
Clinical benefit rate (Arms A, B, and C)
Continued salvage therapy beyond cycle 2 (Arm A, B and C)
Incidence of adverse events
Molecular response (Arm D)
ORR (Arm C)
Overall response rate (ORR) (Arms A and B)
Percent of transplant eligible patients proceeding to transplant (Arms A, B and C)
Transfusion dependency (Arm D)

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Omeprazole
2
GROUP D2 ARM CE
1
rituximab and lenalidomide

Side Effects for

Rituximab
8%Mild/moderate allergic reactions
3%Severe allergic reaction
This histogram enumerates side effects from a completed 2016 Phase 2 & 3 trial (NCT03002038) in the Rituximab ARM group. Side effects include: Mild/moderate allergic reactions with 8%, Severe allergic reaction with 3%.

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

5 Treatment Groups

Arm B (placebo, combination chemotherapy)
1 of 5
Arm D (ascobic acid)
1 of 5
Arm C (ascorbic acid and combination chemotherapy)
1 of 5
Arm D (ascorbic acid)
1 of 5
Arm A (ascorbic acid, combination chemotherapy)
1 of 5

Active Control

Experimental Treatment

55 Total Participants · 5 Treatment Groups

Primary Treatment: Rituximab · Has Placebo Group · Phase 2

Arm D (ascobic acid)Experimental Group · 3 Interventions: Ascorbic Acid, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: DietarySupplement, Other, Other
Arm C (ascorbic acid and combination chemotherapy)Experimental Group · 11 Interventions: Cisplatin, Ascorbic Acid, Carboplatin, Cytarabine, Dexamethasone, Laboratory Biomarker Analysis, Oxaliplatin, Etoposide, Questionnaire Administration, Gemcitabine Hydrochloride, Ifosfamide · Intervention Types: Drug, DietarySupplement, Drug, Drug, Drug, Other, Drug, Drug, Other, Drug, Drug
Arm D (ascorbic acid)Experimental Group · 3 Interventions: Ascorbic Acid, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: DietarySupplement, Other, Other
Arm A (ascorbic acid, combination chemotherapy)Experimental Group · 10 Interventions: Cisplatin, Ascorbic Acid, Carboplatin, Cytarabine, Dexamethasone, Laboratory Biomarker Analysis, Rituximab, Etoposide, Questionnaire Administration, Ifosfamide · Intervention Types: Drug, DietarySupplement, Drug, Drug, Drug, Other, Biological, Drug, Other, Drug
Arm B (placebo, combination chemotherapy)ActiveComparator Group · 10 Interventions: Cisplatin, Carboplatin, Cytarabine, Dexamethasone, Laboratory Biomarker Analysis, Rituximab, Etoposide, Questionnaire Administration, Placebo Administration, Ifosfamide · Intervention Types: Drug, Drug, Drug, Drug, Other, Biological, Drug, Other, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
Ascorbic Acid
2017
Completed Phase 4
~2240
Carboplatin
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Oxaliplatin
FDA approved
Rituximab
FDA approved
Beta-D-Glucose
Not yet FDA approved
Gemcitabine
FDA approved
Ifosfamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,007 Previous Clinical Trials
3,512,825 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,275 Previous Clinical Trials
41,234,757 Total Patients Enrolled
Thomas E WitzigPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
163 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with any type of relapsed or resistant lymphoma, including double-hit high-grade lymphoma and Hodgkin lymphoma, can participate in Arm C. There is no limit to the number of previous treatments for Arm C patients, but they must be eligible for a platinum-based treatment and not have received it before without responding.
References

Frequently Asked Questions

How many different medical clinics are conducting this study?

"Currently, patients are being enrolled at the University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Iowa; Mayo Clinic Health System-Franciscan Healthcare in La Crosse, Wisconsin; and Mayo Clinic in Rochester. Other centres include: ____ , ____ , ____ , ____ , and ___ ." - Anonymous Online Contributor

Unverified Answer

Does Rituximab have FDA backing?

"While there is some data suggesting Rituximab is safe, as this is only a Phase 2 trial, there is no clinical evidence yet of its efficacy. Thus, it received a score of 2." - Anonymous Online Contributor

Unverified Answer

What is the aim of this research?

"The aim of this study, which will take place over the course of 2 years, is to ORR (Arm C). Additionally, we will also be measuring secondary outcomes including overall survival and incidence of adverse events." - Anonymous Online Contributor

Unverified Answer

What are the most popular applications for Rituximab?

"Rituximab has been clinically shown to be effective in the treatment of merkel cell cancer, leukemia, and synovitis." - Anonymous Online Contributor

Unverified Answer

How many individuals are being treated as part of this medical study?

"A total of 147 patients that satisfy the pre-determined inclusion criteria are needed for this clinical trial. Two locations where patients can participate in this study include University of Iowa/Holden Comprehensive Cancer Center and Mayo Clinic Health System-Franciscan Healthcare." - Anonymous Online Contributor

Unverified Answer

Is this research still looking for participants?

"That is correct, the online clinical trials database does show that this study is currently open for recruitment. According to the information available, the trial was first posted on March 23rd, 2018 and was last updated on May 26th, 2022. The researchers running the trial are looking to enroll 147 patients at 5 different locations." - Anonymous Online Contributor

Unverified Answer

What other scientific papers have been published that mention Rituximab?

"Currently, 872 out of 3375 total clinical trials studying Rituximab are in Phase 3. The majority of these investigations into the efficacy of this treatment are based in Guangzhou, Guangdong. However, there are a total 130821 locations worldwide running studies related to Rituximab." - 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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