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

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.

Conditions

• Clonal Cytopenia of Undetermined Significance
• High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Hodgkin Lymphoma
• Recurrent Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Lymphoma
• Chronic Myelomonocytic Leukemia

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Thomas E Witzig, M.D. · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-23

Primary Completion

2031-02-22

Completion

2033-11-02

FDA Drug

Yes

Countries

• United States

Study Locations