2026-02-02
minor
Study Status, Oversight v20
Primary completion date2025-12→2031-02-22
Completion date2026-03→2033-11-02
Show 19 earlier versions
2025-07-11
minor
2 amendments v18-v19
2 re-verifications since 2025-01-23, no change to tracked fields
2024-07-31
minor
Study Status, Study Description, Eligibility v17
Eligibility criteria+15 characters
[...] isease 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 measu [...] informed consent
Willingness to have a central venous line ([peripherally inserted central catheter [(PICC]) or PORT)]
Willingness to provide mandatory blood specimens for correl [...] defined chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation requiring treatment with DNA methyltransferase inh [...]
Study descriptionrevised
[...] elapsed within the first 24 months of end of their therapy.
([Arms A versus [(vs]) B)] II.
To determine the ORR at the end of 2 cycles of AA plus [...] of relapsed/refractory lymphomas not eligible for Arms A/B ([peripheral T-cell lymphoma [(PTCL]), double-hit high grade, and Hodgkin lymphoma [(HL)]).
(Arm C) III.
To assess the hematological response rate to [...]
EXPLORATORY OBJECTIVES:
I. Will include baseline AA levels ([at Mayo Clinic Research [(MCR)]) and staining of pre/post treatment biopsies for markers of [...] sing IV AA and molecular response including clonal dynamics ([new mutations and variant al [...] [...]
2024-07-01
minor
Study Status, Contacts/Locations v16
2024-06-28
minor
Study Identification, Study Status, Contacts/Locations v15
Study sites5 entries, revised
Mayo Clinic inHealth ArizonaSystems-Mankato
Mayo Clinic inHealth FloridaSystem-Eau Claire Clinic
2024-03-29
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v14
Enrollment target55→80
Study arms4→5
InterventionsAscorbic Acid (Dietary Supplement), Carboplatin (Drug), Cisplatin (Drug), Cytarabine (Drug), Dexamethasone (Drug), Etoposide (Drug)…→Ascorbic Acid (Dietary Supplement), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure)…
Eligibility criteria+6,628 characters
[...] uirements of the intravenous ascorbic acid program schedule
ARM E PRE-REGISTRATION: Age ≥ 18 years
ARM E PRE-REGISTRATION: New or an established diagnosis of 2016 World Health Organization (WHO) defined chronic myelomonocytic leukemia with a somatic TET2 mutation requiring treatment with DNA methyltransferase inhibitors/hypomethylating agents
ARM E PRE-REGIS [...] Exclusion Criteria:
Any of the following:
Pregnant persons
N [...] hate dehydrogenase) deficiency (below lower limit of normal)
ARM E PRE-REGISTRATION: Myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) overlap syndromes other than C [...]
Secondary endpoints8 to 10 entries
Clinical benefit rate (Arm E)
Hematologic response rate in Arm E
Primary endpoints3 to 4 entries
Overall Response Rate (ORR) in Arm E
Study description+1,877 characters
[...] openia of undetermined significance (CCUS) patients.
(Arm D) IV.
To assess the hematological response rate to treatment with high dose intravenous ascorbic acid (IV AA) for CCUS patients.
(Arm E)
SECONDARY OBJECTIVES:
I. To compare the adverse event profil [...] l survival (OS) for CCUS patients receiving high dose IV AA. (Arm D) VI.
To define CR, complete cytogenetic remission, partial remission, marrow response, and clinical benefit response rates.
(Arm E) VII.
To determine clinical benefit response rates of erythroid response, platelet response, neutrophil response, spleen response and symptom res [...] [...]
Study title+23 characters
Ascorbic Acid and Combination Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma or, CCUS, and Chronic Myelomonocytic Leukemia
2024-03-15
minor
Study Status v13
Primary completion date2024-03-15→2025-12
Completion date2024-03-15→2026-03
2023-09-25
minor
Study Identification, Study Status, Contacts/Locations, References v12
Study sitescontacts updated at 1 of 5 sites
Study title-41 characters
Ascorbic Acid and Combination Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma or Clonal Cytopenia of Undetermined SignificanceCCUS
2023-05-01
minor
Study Identification, Study Status, Study Design v11
2023-01-17
minor
Study Status, Study Description, Arms and Interventions, Eligibility v10
Eligibility criteria+17 characters
Inclusion Criteria:
Age >= 18 years
Biopsy-proven relapsed or refractory lymphomas; relapsed is [...] otrexate (MTX); Note: Patients with any prior CNS lymphoma (parenchymalorparenchymal or leptomeningeal) MUST be in complete remission (CR) in those [...]
Study description+3 characters
[...] aliplatin, cytarabine, and dexamethasone IV or PO according to standard regimen schedule.
Treatment repeats every 21 days f [...]
2022-05-26
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v9
Eligibility criteria-384 characters
[...] ecifically for relapse
NOTE: Arm C patients include relapsed or refractory lymphoma patients of any type for which the recommended tre [...] ludes one of the platinum-based regimens; of note, relapsed or refractory double-hit high grade lymphoma patients and relapsed or refractory Hodgkin lymphoma patients will be enrolled in Arm C; there [...] ired
Patients with uncontrolled or symptomatic kidney stones; NOTE: Patients with calcium oxalate crystals on baseline urinalysis or a history of symptomatic calcium oxalate stones must be seen or have an e-consult by the Nephrology Stone Clinic and placed on a low [...] [...]
Study description+22 characters
[...] alvage chemotherapy in patients with other types of relapsed/refractory lymphomas not eligible for Arms A/B (peripheral T-cell lymp [...] ate of AA added to salvage therapy in patients with relapsed/refractory lymphoma.
(Arm C) V. To assess safety/tolerability, transfu [...]
2021-08-20
minor
Study Identification, Study Status, Study Description, Outcome Measures v8
Secondary endpoints8 entries, revised
Clinical benefit rate (Arms A, B, and C)
Percent of transplant eligible patients proceeding to transplant (Arms A, B and C)
Continued salvage therapy beyond cycle 2 (Arm A, B and C)
Primary endpoints2 to 3 entries
Hematologic response (HI) rate (Arm D)
Study description+256 characters
[...] A, B, and C Correlative Research on blood and tumor tissue) II.
To assess the association between using AA and non-hematological endpoints.
(Arm D correlative research) IIa.
To assess theTET2 associationactivity betweenat usingbaseline, AAweeks 12, 20, and endothelial dysfunction52.
(Arm D correlative research) IIb.
To assess the association between using AA and the inflammationhydroxymethylation markersand methylation status (gene-specific and global changes in 5mC/5hmC level) at baseline and weeks 20 and 52.
(Arm D correlative research) IIc.
To assess the association between using IV AA and [...]
2021-06-15
minor
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Eligibility criteria+3,561 characters
[...] uirements of the intravenous ascorbic acid program schedule
ARM D: Patients who had a diagnosis of CCUS with one or more TET2 mutations or TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2) or epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2).
CCUS diagnosis being defined based on the absence of definitive morpho [...] Exclusion Criteria:
Any of the following:
Pregnant persons
N [...] o enrollment
Known paroxysmal nocturnal hemoglobinuria (PNH)
ARM D: Bona-fide hematological neoplasm
ARM D: Any of the following because this study involves an agent that has known [...]
Secondary endpoints7 to 8 entries
IncidenceTransfusion of adverse events assessed using Common Terminology Criteria for Adverse Eventsdependency (CTCAEArm D)
Incidence of adverse events
Incidence assessedof usingadverse Patient Reported Outcomes (PRO)-CTCAE (Arms A and B)events
Primary endpoints2 entries, revised
ORR (Arm C) defined as an objective status of CR or PR evaluated by RECIL criteria after 2 cycles of treatment
Overall response rate (ORR) (Arms A and B) defined as an objective status of complete response (CR) or partial response (PR) evaluated by Response Evaluation Criteria in Lymphoma (RECIL) criteria after 2 courses of treatment in all arms
Study description+1,115 characters
[...] , double-hit high grade, and Hodgkin lymphoma [HL]).
(Arm C) III.
To assess the hematological response rate to treatment with high dose intravenous ascorbic acid (IV AA) for clonal cytopenia of undetermined significance (CCUS) patients.
(Arm D)
SECONDARY OBJECTIVES:
I. To compare the adverse event profil [...] salvage therapy in patients with relapsed lymphoma.
(Arm C) V. To assess safety/tolerability, transfusion dependency (TD), progression-free survival (PFS), and overall survival (OS) for CCUS patients receiving high dose IV AA.
EXPLORATORY OBJECTIVEOBJECTIVES:
I. Will include baseline AA levels [...] [...]
Study sitescontacts updated at 1 of 5 sites
Study title+44 characters
Ascorbic Acid and Combination Chemotherapy infor Treatingthe PatientsTreatment Withof Relapsed or Refractory Lymphoma or Clonal Cytopenia of Undetermined Significance
2021-03-11
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Enrollment target151→147
InterventionsAscorbic Acid (Dietary Supplement), Carboplatin (Drug), Cisplatin (Drug), Cytarabine (Drug), Dexamethasone (Drug), Etoposide (Drug)…→Ascorbic Acid (Dietary Supplement), Carboplatin (Drug), Cisplatin (Drug), Cytarabine (Drug), Dexamethasone (Drug), Etoposide (Drug)…
Eligibility criteria-66 characters
[...] reatment on this protocol will be acceptable
NOTE: Arms A/B ?
- relapsed or refractory DLBCL within 24 months from the end o [...] rm C patients include relapsed lymphoma patients of any type, other than those eligible for Arms A/B, for which the recommended treatment includes one of the pla [...] s the assessable disease is biopsy proven lymphoma
Arms A/B ?
- eligible for treatment with ifosfamide, carboplatin, and eto [...] cytarabine (cytosine arabinoside), dexamethasone (DHAP) or rituximab, cisplatin, cytosine arabinoside, dexamethasone (RDHAP);
Gemcitabine hydrochloride (gemcitabine), dexamethasone, ci [...] firmed [...]
Secondary endpoints7 entries, revised
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE)
Study description-1 characters
[...] I.
To compare the ORR at the end of 4 cycles for those with Minorminor response/stable disease at the end of cycle 2 who proceed t [...] salvage therapy in patients with relapsed lymphoma.
(Arm C)
TERTIARYEXPLORATORY OBJECTIVESOBJECTIVE:
I. Will include baseline AA levels (at Mayo Clinic Researc [...] receive ascorbic acid IV on days 1, 3, 5, 8, 10, 12, 15, 17, and 19, and rituximab intravenously (IV), ifosfamide IV, ca [...] achieve minor response (MR) or stable disease (SD) after 2 coursescycles may receive rituximab IV or PO, cisplatin IV or PO, cytarab [...] asone IV or PO.
Treatment repeats every 21 days for up to [...]
Study sites5 entries, revised
Mayo Clinic in Rochester
Mayo Clinic Health System-Franciscan La CrosseHealthcare
2020-06-12
minor
Study Status, Contacts/Locations v5
2020-05-27
minor
Study Status, Contacts/Locations v4
Study sitescontacts updated at 3 of 4 sites
2019-05-14
notable
Suspended→Recruiting Study Status, Contacts/Locations v3
Trial statusSuspended→Recruiting
Reason stoppedPer study design to evaluate nephrotoxicity for patients enrolled to the RICE/ICE Regimen in Arm C→not stated
Study sitesdetails revised at 4 of 4 sites
2019-03-21
notable
Recruiting→Suspended Study Status, Contacts/Locations v2
Trial statusRecruiting→Suspended
Reason stoppednot stated→Per study design to evaluate nephrotoxicity for patients enrolled to the RICE/ICE Regimen in Arm C
Study sitesdetails revised at 4 of 4 sites
2018-03-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-03-15→confirmed 2018-03-23
Study sitesdetails revised at 4 of 4 sites