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

Conditions

• Chronic Myelomonocytic Leukemia
• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ascorbic Acid — DIETARY_SUPPLEMENT
  Given IV
• Carboplatin — DRUG
  Given IV or PO
• Cisplatin — DRUG
  Given IV or PO
• Cytarabine — DRUG
  Given IV or PO
• Dexamethasone — DRUG
  Given IV or PO
• Etoposide — DRUG
  Given IV or PO
• Gemcitabine Hydrochloride — DRUG
  Given IV or PO
• Ifosfamide — DRUG
  Given IV or PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Oxaliplatin — DRUG
  Given IV or PO
• Placebo Administration — OTHER
  Given normal saline IV
• Questionnaire Administration — OTHER
  Ancillary studies
• Rituximab — BIOLOGICAL
  Given IV
• Decitabine — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Core Biopsy — PROCEDURE
  Undergo core needle biopsy
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Echocardiography — PROCEDURE
  Undergo ECHO
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Central Venous Cannula Insertion — PROCEDURE
  Undergo PICC placement
• Portacath Placement — PROCEDURE
  Undergo portacath placement
• Computed Tomography — PROCEDURE
  Undergo PET/CT

Study Details

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.

Key Dates

Start date

Mar 23, 2018

Status verified

Apr 2026

Primary completion

Feb 22, 2031

Completion

Nov 2, 2033

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (ascorbic acid, combination chemotherapy) - closed to enrollment
  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.
• Active Comparator: Arm B (placebo, combination chemotherapy) - closed to enrollment
  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.
• Experimental: Arm C (ascorbic acid and combination chemotherapy) - closed to enrollment
  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.
• Experimental: Arm D (ascorbic acid) - closed to enrollment
  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.
• Experimental: ARM E (ascorbic acid, decitabine)
  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.

Primary Outcome Measure

Overall response rate (ORR) (Arms A and B) [ Time Frame: Up to 2 years ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]

Locations (4)

Find similar trials in Mankato, MN

Related Studies

• Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
  Recruiting · Children's Oncology Group · Birmingham, Alabama
• Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
  Recruiting · Mayo Clinic · Scottsdale, Arizona
• A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
  PHASE2 · Enrolling By Invitation · Taiho Oncology, Inc. · Fountain Valley, California
• A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
  PHASE2/PHASE3 · Recruiting · Taiho Oncology, Inc. · Los Angeles, California