RecruitingPhase 2NCT03418038

Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia

Phase2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed/ Refractory Lymphoma, Patients With Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia


Sponsor

Mayo Clinic

Enrollment

80 participants

Start Date

Mar 23, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells. Arms A, B, C, and D are closed to enrollment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether high-dose intravenous vitamin C given alongside chemotherapy can improve outcomes for patients with lymphoma (blood cancer) or certain types of leukemia that have come back or stopped responding to treatment. **You may be eligible if...** - You are 18 years or older - You have a diagnosed lymphoma or a specific type of leukemia (CCUS or chronic myelomonocytic leukemia) that has relapsed or is not responding to treatment - You have not received certain prior chemotherapy regimens (varies by treatment arm) - You are in generally good health and your organs are functioning adequately - You are not pregnant and are willing to use contraception if applicable **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal fluid - You have a G6PD enzyme deficiency (a genetic condition that can cause a reaction to high-dose vitamin C) - You are currently receiving other investigational treatments - You have serious kidney problems or are on dialysis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTAscorbic Acid

Given IV

DRUGCarboplatin

Given IV or PO

DRUGCisplatin

Given IV or PO

DRUGCytarabine

Given IV or PO

DRUGDexamethasone

Given IV or PO

DRUGEtoposide

Given IV or PO

DRUGGemcitabine Hydrochloride

Given IV or PO

DRUGIfosfamide

Given IV or PO

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGOxaliplatin

Given IV or PO

OTHERPlacebo Administration

Given normal saline IV

OTHERQuestionnaire Administration

Ancillary studies

BIOLOGICALRituximab

Given IV

DRUGDecitabine

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDURECore Biopsy

Undergo core needle biopsy

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDURECentral Venous Cannula Insertion

Undergo PICC placement

PROCEDUREPortacath Placement

Undergo portacath placement

PROCEDUREComputed Tomography

Undergo PET/CT


Locations(4)

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03418038


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