Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

Brief Title

Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

Official Title

Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

Brief Summary

      This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after
      myeloablative allogeneic stem cell transplant.
    

Detailed Description

      Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who
      have a stem cell transplant have lower than normal levels of vitamin C in their blood.
      Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed
      by oral vitamin C until six months after transplant. The effect of the Vitamin C on
      non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and
      to characterize the safety and tolerability of the vitamin C regimen.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The proportion of patients that experience non-relapse mortality (NRM)

Secondary Outcome

 Time from transplant to engraftment

Condition

Hodgkin Lymphoma

Intervention

Intravenous (IV) and oral Vitamin C

Study Arms / Comparison Groups

 IV Vitamin C followed by oral Vitamin C
Description:  All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

October 1, 2018

Completion Date

October 31, 2022

Primary Completion Date

October 31, 2021

Eligibility Criteria

        Inclusion Criteria:

        A patient must meet all of the following inclusion criteria to be eligible to participate
        in the study:

          1. Any of the following hematological malignancies:

               -  Acute lymphoblastic leukemia

               -  Acute myelogenous leukemia

               -  Chronic myelogenous leukemia

               -  Myelodysplasia

          2. Candidate for HCT Note: Patients with or without previous myeloablative autologous
             transplant are eligible.

          3. HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated
             (8/8 or 7/8 loci matched)

          4. Stem cell graft from either bone marrow or peripheral blood

          5. Negative serology for HIV

          6. Age ≥ 18 to < 78 years of age

          7. Karnofsky Performance Status of 70-100%

          8. Women who are not postmenopausal or have not undergone hysterectomy must have a
             documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines

          9. Ability to understand and the willingness to sign a written informed consent document.
             Note: The consent form must be signed and dated prior to initiation of SCT preparative
             treatments.

        Exclusion Criteria:

          -  A patient who meets any of the following exclusion criteria is ineligible to
             participate in the study.

               1. Known allergy to vitamin C

               2. Inability to swallow oral medication

               3. Known or suspected malabsorption condition or obstruction

               4. G6PDH deficiency

               5. Uncontrolled viral, fungal, or bacterial infection

               6. Active meningeal or central nervous system disease

               7. Alternative HCT including haplo-identical and umbilical cord transplants

               8. Non-myeloablative conditioning defined as TBI < 2 cGy

               9. Pregnancy or breastfeeding

              10. Medical, psychological, or social condition that, in the opinion of the
                  investigator, may increase the patient's risk or limit the patient's adherence
                  with study requirements
      

Gender

All

Ages

18 Years - 77 Years

Accepts Healthy Volunteers

No

Contacts

Gary L Simmons, DO, 804-828-1292, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03613727

Organization ID

MCC-17-13299

Secondary IDs

NCI-2018-01502

Responsible Party

Sponsor

Study Sponsor

Virginia Commonwealth University


Study Sponsor

Gary L Simmons, DO, Principal Investigator, Massey Cancer Center


Verification Date

June 2020