Lymphoid Leukemia, Monocytic Leukemia, Myelodysplasia, Myeloid Leukemia
Conditions
Keywords
Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)
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.
Interventions
DRUGIntravenous (IV) and oral Vitamin C
Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No
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 hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible. 3. human leukocyte antigen (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 Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (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 stem cell transplant (SCT) preparative treatments.
Exclusion criteria
* A patient who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients That Experience Non-relapse Mortality (NRM) | 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT) | To determine the effect of parenteral vitamin C on non-relapse mortality (NRM) at one year following myeloablative allogeneic HCT. Non-relapse mortality is defined as defined as mortality from complications of HCT but not tumor relapse, is usually from graft versus host disease (GVHD), infection, or organ failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Transplant to Engraftment | 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT) | To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment. |
| To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD) | 0 - 180 days after myeloablative allogeneic HCT | Percentage of patients with a diagnosis of acute GVHD |
| Determine Related to Vitamin C Therapy Adverse Events (AEs) Reported Using Criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) | Within first 30 days of myeloablative allogeneic HCT | The number of participants who have adverse events related to Vitamin C therapy |
Countries
United States
Participant flow
Pre-assignment details
6 participants were consented and enrolled, but were not eligible to start treatment
Participants by arm
| Arm | Count |
|---|---|
| IV Vitamin C Followed by Oral Vitamin C 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.
Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours
• After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180 | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | IV Vitamin C Followed by Oral Vitamin C |
|---|---|
| Age, Customized 18 - 21 years | 1 Participants |
| Age, Customized 22 - 29 years | 2 Participants |
| Age, Customized 30 - 39 years | 7 Participants |
| Age, Customized 40 - 49 years | 5 Participants |
| Age, Customized 50 - 59 years | 21 Participants |
| Age, Customized 60 - 69 years | 18 Participants |
| Age, Customized 70 - 79 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 55 |
| other Total, other adverse events | 55 / 55 |
| serious Total, serious adverse events | 40 / 55 |
Outcome results
Primary
The Proportion of Patients That Experience Non-relapse Mortality (NRM)
To determine the effect of parenteral vitamin C on non-relapse mortality (NRM) at one year following myeloablative allogeneic HCT. Non-relapse mortality is defined as defined as mortality from complications of HCT but not tumor relapse, is usually from graft versus host disease (GVHD), infection, or organ failure.
Time frame: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Vitamin C Followed by Oral Vitamin C | The Proportion of Patients That Experience Non-relapse Mortality (NRM) | 5 Participants |
Secondary
Determine Related to Vitamin C Therapy Adverse Events (AEs) Reported Using Criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
The number of participants who have adverse events related to Vitamin C therapy
Time frame: Within first 30 days of myeloablative allogeneic HCT
Population: No participants had adverse events related to Vitamin C therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Vitamin C Followed by Oral Vitamin C | Determine Related to Vitamin C Therapy Adverse Events (AEs) Reported Using Criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) | 0 Participants |
Secondary
Time From Transplant to Engraftment
To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.
Time frame: 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Vitamin C Followed by Oral Vitamin C | Time From Transplant to Engraftment | 12 Number of Days to engraftment |
Secondary
To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)
Percentage of patients with a diagnosis of acute GVHD
Time frame: 0 - 180 days after myeloablative allogeneic HCT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Vitamin C Followed by Oral Vitamin C | To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD) | 33 percentage of participants |