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RECRUITING
NCT03418038
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2018-03-23

Completion Date

2033-11-02

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Ascorbic Acid

Given IV

DRUG

Carboplatin

Given IV or PO

DRUG

Cisplatin

Given IV or PO

DRUG

Cytarabine

Given IV or PO

DRUG

Dexamethasone

Given IV or PO

DRUG

Etoposide

Given IV or PO

DRUG

Gemcitabine Hydrochloride

Given IV or PO

DRUG

Ifosfamide

Given IV or PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Oxaliplatin

Given IV or PO

OTHER

Placebo Administration

Given normal saline IV

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Rituximab

Given IV

DRUG

Decitabine

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Core Biopsy

Undergo core needle biopsy

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Central Venous Cannula Insertion

Undergo PICC placement

PROCEDURE

Portacath Placement

Undergo portacath placement

PROCEDURE

Computed 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