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Chemotherapy
Ascorbic Acid + Chemotherapy for Lymphoma
Phase 2
Recruiting
Led By Thomas E Witzig
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Creatinine =< 1.6 mg/dL; if over 1.6 then the calculated creatinine clearance must be >= 55 ml/min using the Cockcroft-Gault formula, obtained =< 7 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
Who is the study for?
Adults with recurrent or refractory lymphoma, including various subtypes like Diffuse Large B-Cell Lymphoma, who haven't responded to therapy within 6 months or have relapsed after a response lasting more than 6 months. Participants must be in good physical condition (ECOG PS 0-2), able to return for follow-up, and have measurable disease. They should not be pregnant/nursing and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of ascorbic acid (vitamin C) combined with chemotherapy drugs such as Ifosfamide, Carboplatin, Etoposide, Rituximab and others against lymphomas that are difficult to treat. The goal is to see if vitamin C can make cancer cells more vulnerable to chemo.See study design
What are the potential side effects?
Possible side effects include reactions related to high doses of vitamin C and typical chemotherapy effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, kidney issues from certain drugs used in the regimen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney function, measured by creatinine levels, is within the required range.
Select...
I was diagnosed with CCUS and have specific genetic changes.
Select...
I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hematologic response (HI) rate (Arm D)
ORR (Arm C)
Overall Response Rate (ORR) in Arm E
+1 moreSecondary outcome measures
Clinical benefit rate (Arm E)
Clinical benefit rate (Arms A, B, and C)
Continued salvage therapy beyond cycle 2 (Arm A, B and C)
+6 moreOther outcome measures
Biomarker analysis (Arm D)
Biomarker analysis on blood and tissue (Arms A, B, and C)
Molecular response (Arm D)
+1 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (ascorbic acid)Experimental Treatment8 Interventions
Patients receive ascorbic acid IV TIW. Treatments repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PICC or portacath placement prior to starting treatment, blood sample collection, bone marrow aspiration and biopsy throughout study.
Group II: Arm C (ascorbic acid and combination chemotherapy)Experimental Treatment19 Interventions
Patients receive ascorbic acid IV on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Patients also receive ifosfamide, carboplatin, and etoposide IV or PO, or cisplatin, cytarabine, and dexamethasone IV or PO, or gemcitabine hydrochloride, dexamethasone, and cisplatin IV or PO, or gemcitabine hydrochloride and oxaliplatin IV or PO, or oxaliplatin, cytarabine, and dexamethasone IV or PO according to standard regimen schedule. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve MR or SD after 2 cycles may switch to an alternative chemotherapy regimen. Patients additionally, undergo blood sample collection, core needle biopsy, bone marrow aspiration and biopsy, ECHO, PET/CT or MRI throughout study.
Group III: Arm A (ascorbic acid, combination chemotherapy)Experimental Treatment18 Interventions
Patients receive ascorbic acid IV on days 1, 3, 5, 8, 10, 12, 15, 17, and 19, and rituximab intravenously IV, ifosfamide IV, carboplatin IV and etoposide IV on days 1-3. Patients who achieve MR or SD after 2 cycles may receive rituximab IV or PO, cisplatin IV or PO, cytarabine IV or PO, and dexamethasone IV or PO. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients additionally, undergo blood sample collection, core needle biopsy, bone marrow aspiration and biopsy, ECHO, PET/CT or MRI throughout study.
Group IV: ARM E (ascorbic acid, decitabine)Experimental Treatment7 Interventions
Patients receive ascorbic acid IV on days 1, 3 and 5 and decitabine IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 12 cycles may continue decitabine with or without ascorbic acid as long as clinically appropriate. Patients may also take vitamin C PO on days 6-28. Patients undergo PICC or portacath placement prior to starting treatment, blood sample collection, bone marrow aspiration and biopsy throughout study.
Group V: Arm B (placebo, combination chemotherapy)Active Control18 Interventions
Patients receive placebo (normal saline) IV on days 1, 3, 5, 8, 10, 12, 15, 17, and 19, and rituximab intravenously IV, ifosfamide IV, carboplatin IV and etoposide IV on days 1-3. Patients who achieve MR or SD after 2 cycles may receive rituximab IV or PO, cisplatin IV or PO, cytarabine IV or PO, and dexamethasone IV or PO. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients additionally, undergo blood sample collection, core needle biopsy, bone marrow aspiration and biopsy, ECHO, PET/CT or MRI throughout study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Echocardiography
2013
Completed Phase 4
~11670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Rituximab
1999
Completed Phase 4
~1880
Decitabine
2004
Completed Phase 3
~1680
Core Biopsy
2013
N/A
~130
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Cytarabine
2016
Completed Phase 3
~3310
Dexamethasone
2007
Completed Phase 4
~2590
Cisplatin
2013
Completed Phase 3
~1940
Oxaliplatin
2011
Completed Phase 4
~2560
Ascorbic Acid
2017
Completed Phase 4
~2240
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Ifosfamide
2010
Completed Phase 4
~2980
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,931 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,925 Total Patients Enrolled
Thomas E WitzigPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a blood cancer.My white blood cell count is healthy.My lymphoma has returned or didn't respond to treatment, and I had a biopsy within the last 6 months.I have active brain lymphoma or cancer cells in my spinal fluid needing specific treatment.I have been diagnosed with PNH.I am aware the study drug may affect my DNA and reproductive health.I am 18 years old or older.My kidney function, measured by creatinine levels, is within the required range.I have cancer other than lymphoma.I have a known G6PD deficiency.I have kidney stones that are not managed or cause symptoms.I do not have any severe illnesses that could interfere with the study.I have not had a heart attack in the last 6 months and my heart functions well.My hemoglobin level is at least 8.0 g/dL.I am willing to give tissue samples for research.I was diagnosed with CCUS and have specific genetic changes.I have a tumor that can be measured and is at least 1.5 cm in size.I am willing to have a central venous line placed.My liver enzymes are within the required range for the trial.I haven't had any cancer treatment in the last 2 weeks.I am able to care for myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (placebo, combination chemotherapy)
- Group 2: ARM E (ascorbic acid, decitabine)
- Group 3: Arm C (ascorbic acid and combination chemotherapy)
- Group 4: Arm D (ascorbic acid)
- Group 5: Arm A (ascorbic acid, combination chemotherapy)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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 ___ ."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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