B-Cell Non-Hodgkin LymphomaPhase 2NCT03505762
Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment
A Phase 2 study testing Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis in people with B-Cell Non-Hodgkin Lymphoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This phase II trial studies how well tailored prednisone reduction works in preventing hyperglycemia in participants with B-cell non-Hodgkin lymphoma receiving combination chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to Jun 2029
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of B cell non-Hodgkin lymphoma confirmed by World Health Organization (WHO) criteria
- Planned treatment with R-CHOP chemotherapy
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
- Life expectancy of greater than 3 months with chemotherapy
- The effects of R-CHOP on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Who cannot join
- Uncontrolled human immunodeficiency virus (HIV), CD4 count < 50
- Diagnosis of primary central nervous system (CNS) lymphoma
- Unable to receive R-CHOP chemotherapy
- History of severe (i.e. anaphylactic) allergic reactions attributed to compounds of similar chemical or biologic composition to glucocorticoids and other component of R-
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection not controlled with antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia that cannot be rate controlled with medications, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because R-CHOP includes D Class agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with R-CHOP, breastfeeding should be discontinued if the mother is treated with these agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Phase II Pilot of Tailored Prednisone Reduction Versus Usual Care for the Treatment of Hyperglycemia During R-CHOP Chemotherapy
This phase II trial studies how well tailored prednisone reduction works in preventing hyperglycemia in participants with B-cell non-Hodgkin lymphoma receiving combination chemotherapy treatment. Drugs used in chemotherapy, such as rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Reductions in prednisone dose may lower blood sugar levels.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the cumulative incidence of hyperglycemia after 3 cycles of treatment between standard or tailored R-CHOP chemotherapy
SECONDARY OBJECTIVES:
- To compare the cumulative incidence of hyperglycemia after 6 cycles of treatment and at 6 months post-treatment between standard or tailored R-CHOP chemotherapy II. To compare response rates after 6 cycles of treatment as measured by Cheson's criteria between standard or tailored R-CHOP chemotherapy.
III. To compare cumulative rates of grade III or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE) criteria between standard or tailored R-CHOP chemotherapy from cycle 1 through cycle 6.
IV. To compare severity of prednisone related adverse events using the Patient Reported Outcome (PRO)-CTCAE form between standard or tailored R-CHOP chemotherapy from cycle 1 through cycle 6.
- To compare health related quality of life (HRQOL) between standard or tailored R-CHOP chemotherapy at baseline, cycle 4 day 1 and after cycle 6.
EXPLORATORY OBJECTIVES:
- To evaluate the alternative glucose measures of fasting blood glucose (FBG), hemoglobin A1c (HbA1c), fasting insulin and fructosamine to estimate hyperglycemia.
II. To compare health related quality of life (HRQOL) in those with and without hyperglycemia after 3 cycles, 6 cycles, and 6 months post R-CHOP chemotherapy.
III. To compare glycemic variability between the standard and tailored prednisone arms at day 1 of each cycle IV. To determine the ability of patients in the standard or tailored prednisone R-CHOP groups to complete all six cycles of chemotherapy.
- To compare overall survival (OS) between standard or tailored R-CHOP chemotherapy
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive rituximab intravenously (IV), vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose orally (PO) once daily (QD) on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up to 5 years.
- Conditions
- B-Cell Non-Hodgkin Lymphoma
- Being tested
- Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Prednisone, Quality-of-Life Assessment
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary correlative
Questionnaire AdministrationOther
Ancillary studies
RituximabBiological
Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody
Given IV
Also called Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (tailored prednisone dose) | Experimental | Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Prednisone; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Rituximab; Drug: Vincristine Sulfate |
| Arm II (usual care prednisone dose) | Active comparator | Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Prednisone; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Rituximab; Drug: Vincristine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Percentage of Patients With Hyperglycemia Patients of Standard or Tailored Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate and Prednisone (R-CHOP)
Will use the Kaplan Meier method to estimate the cumulative percentage of patients with hyperglycemia, and the log-rank test to compare hyperglycemia rates by arm after 3 cycles of R-CHOP chemotherapy.
Measured: After course 3 (63 days)
Secondary outcomes (5)
Cumulative Incidence of Hyperglycemia of Standard or Tailored R-CHOP
Will use the Kaplan Meier method to estimate the cumulative incidence of hyperglycemia, and the log-rank test to compare hyperglycemia incidence by arm after 6 cycles and after 6 months (up to 400 days from start of treatment) of R-CHOP chemotherapy.
Measured: from baseline through 6 cycles (126 days) and at 6 months after completion of chemotherapy
Response Rates of Standard or Tailored R-CHOP as Measured by Cheson's Criteria
Will use a Fisher's exact test to compare response rates (complete response) through 6 cycles of R-CHOP by arm. Response is determined by Cheson's criteria.
Measured: After course 6 (126 days)
Rates of Grade III or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE) Criteria From Standard or Tailored R-CHOP
Will compare the rates of the incidence of grade III and higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE) criteria by arm of R-CHOP for each cycle using Fisher's exact tests.
Measured: Up to 6 months (up to 400 days from start of treatment)
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE
Compare the worst severity of PRO-CTCAE assessments by arm of R-CHOP using two group t-tests. The questionnaire was completed at each cycle (1-6) and the worst response for each participant for each measure was calculated for comparison. Severity for each measure was captured on a 5 point scale with 1=None and 5=Very severe.
Measured: Up to course 6 (126 days)
Health Related Quality of Life (HRQOL) Scores
Evaluated using the Functional Assessment of Cancer Therapy (FACT)-Lymphoma, FACT Gynecologic Oncology Group (GOG)-Neurotoxicity (nxt) additional concerns and Patient-Reported Outcomes Measurement Information System 29. Will compare the HRQOL measures between arms receiving R-CHOP chemotherapy using two group t-tests at each time point of interest (day 1 of cycles 1, and 4, after cycle 6, and 6 months post treatment (up to 400 days from start of treatment)). Measures reported are the total FACT-lymphoma score ranging from 0-168 and the FACT-GOG neurotoxicity subscale ranging from 0-16. For both measures higher values indicate of better health related quality of life.
Measured: Day 1 of cycles 1, 4, 6, and 6 months post treatment (up to 400 days from start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start19 Jul 2018
- Primary completion28 Mar 2024
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rakhee Vaidya, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505762
- Sponsor's protocol ID
- IRB00050108
- Other IDs
- NCI-2018-00585, CCCWFU 98317, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2018
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Pilot of Tailored Prednisone Reduction Versus Usual Care for the Treatment of Hyperglycemia During R-CHOP Chemotherapy
- ClinicalTrials.gov ID
- NCT03505762
- Acronym / sponsor ID
- IRB00050108
- Conditions
- B-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- Jun 2029 (estimated)
- First posted
- 23 Apr 2018 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well tailored prednisone reduction works in preventing hyperglycemia in participants with B-cell non-Hodgkin lymphoma receiving combination chemotherapy treatment. Drugs used in chemotherapy, such as rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Reductions in prednisone dose may lower blood sugar levels.
Detailed description
PRIMARY OBJECTIVES:
- To compare the cumulative incidence of hyperglycemia after 3 cycles of treatment between standard or tailored R-CHOP chemotherapy
SECONDARY OBJECTIVES:
- To compare the cumulative incidence of hyperglycemia after 6 cycles of treatment and at 6 months post-treatment between standard or tailored R-CHOP chemotherapy II. To compare response rates after 6 cycles of treatment as measured by Cheson's criteria between standard or tailored R-CHOP chemotherapy.
III. To compare cumulative rates of grade III or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE) criteria between standard or tailored R-CHOP chemotherapy from cycle 1 through cycle 6.
IV. To compare severity of prednisone related adverse events using the Patient Reported Outcome (PRO)-CTCAE form between standard or tailored R-CHOP chemotherapy from cycle 1 through cycle 6.
- To compare health related quality of life (HRQOL) between standard or tailored R-CHOP chemotherapy at baseline, cycle 4 day 1 and after cycle 6.
EXPLORATORY OBJECTIVES:
- To evaluate the alternative glucose measures of fasting blood glucose (FBG), hemoglobin A1c (HbA1c), fasting insulin and fructosamine to estimate hyperglycemia.
II. To compare health related quality of life (HRQOL) in those with and without hyperglycemia after 3 cycles, 6 cycles, and 6 months post R-CHOP chemotherapy.
III. To compare glycemic variability between the standard and tailored prednisone arms at day 1 of each cycle IV. To determine the ability of patients in the standard or tailored prednisone R-CHOP groups to complete all six cycles of chemotherapy.
- To compare overall survival (OS) between standard or tailored R-CHOP chemotherapy
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive rituximab intravenously (IV), vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose orally (PO) once daily (QD) on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (tailored prednisone dose) | Experimental | Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Prednisone, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Biological: Rituximab, Drug: Vincristine SulfateParticipants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II (usual care prednisone dose) | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Prednisone, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Biological: Rituximab, Drug: Vincristine SulfateParticipants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of B cell non-Hodgkin lymphoma confirmed by World Health Organization (WHO) criteria
- Planned treatment with R-CHOP chemotherapy
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
- Life expectancy of greater than 3 months with chemotherapy
Key exclusion criteria (6 listed)
- Uncontrolled human immunodeficiency virus (HIV), CD4 count < 50
- Diagnosis of primary central nervous system (CNS) lymphoma
- Unable to receive R-CHOP chemotherapy
- History of severe (i.e. anaphylactic) allergic reactions attributed to compounds of similar chemical or biologic composition to glucocorticoids and other component of R-
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection not controlled with antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia that cannot be rate controlled with medications, or psychiatric illness/social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV | Drug | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| Doxorubicin HydrochlorideAlso: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, AdriamycinGiven IV | Drug | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven PO | Drug | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary correlative | Other | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| RituximabAlso: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 AntibodyGiven IV | Biological | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
| Vincristine SulfateAlso: Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, OncovinGiven IV | Drug | Arm I (tailored prednisone dose), Arm II (usual care prednisone dose) |
Primary outcome
Cumulative Percentage of Patients With Hyperglycemia Patients of Standard or Tailored Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate and Prednisone (R-CHOP)
Time frame: After course 3 (63 days)
Will use the Kaplan Meier method to estimate the cumulative percentage of patients with hyperglycemia, and the log-rank test to compare hyperglycemia rates by arm after 3 cycles of R-CHOP chemotherapy.
5 secondary outcomes
Cumulative Incidence of Hyperglycemia of Standard or Tailored R-CHOP
Time frame: from baseline through 6 cycles (126 days) and at 6 months after completion of chemotherapy
Response Rates of Standard or Tailored R-CHOP as Measured by Cheson's Criteria
Time frame: After course 6 (126 days)
Rates of Grade III or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE) Criteria From Standard or Tailored R-CHOP
Time frame: Up to 6 months (up to 400 days from start of treatment)
Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE
Time frame: Up to course 6 (126 days)
Health Related Quality of Life (HRQOL) Scores
Time frame: Day 1 of cycles 1, 4, 6, and 6 months post treatment (up to 400 days from start of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakhee Vaidya, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis in people with B-Cell Non-Hodgkin Lymphoma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Percentage of Patients With Hyperglycemia Patients of Standard or Tailored Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate and Prednisone (R-CHOP) (time frame: After course 3 (63 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.