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Diffuse Large B Cell LymphomaPhase 2NCT03943901

Split-Dose R-CHOP for Older Adults With DLBCL

A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Diffuse Large B Cell Lymphoma and DLBCL, run by University of Wisconsin, Madison at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is investigating a new administration schedule of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) chemotherapy for participants with Diffuse Large B-Cell Lymphoma (DLBCL), focusing on an underserved elderly population (aged 75 and up; certain participants 70-74 may be eligible)… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma, DLBCL, Cancer
What is being tested?
Rituximab, Cyclophosphamide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
17 Feb 2021to Feb 2027
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Signed and dated informed consent document indicating that the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
  • All patients age ≥75 years and participants aged 70-74 years who are determined to be unfit or frail by Cumulative Illness Rating Score-Geriatrics (CIRS-G) scale
  • For participants aged 70-74 years: CIRS-G score with 5-8 comorbid conditions scored 2 or ≥1 comorbidity scored 3-4. CIRS-G score is to be reviewed by the study PI prior to enrollment.
  • Newly diagnosed, untreated, biopsy proven CD20 positive DLBCL (including high grade B-cell lymphoma \& T-cell/histiocytic rich large B-cell lymphoma). Participants with discordant bone marrow (i.e. involved by low-grade/indolent NHL) are eligible. Participants with transformed DLBCL from underlying low-grade disease are eligible. Participants with composite DLBCL and concurrent low-grade lymphoma are eligible.
  • Copy of pathology report must be sent to coordinating site to confirm diagnosis for eligibility
  • Participants with prior treatment for low grade NHL with non-anthracycline based regimens are eligible
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  • Measurable disease by PET/CT or Bone Marrow (BM) biopsy prior to enrollment
  • Left ventricular ejection fraction ≥50% by resting echocardiography or resting Multi-gated acquisition (MUGA) scan
  • Karnofsky Performance Score ≥50
  • Ann Arbor Stage II bulky, III, or IV disease
  • Minimum life expectancy greater than 3 months
  • Negative HIV test
  • For participants with hepatitis B virus antigen (HbsAg) or core antibody (HbcAb) seropositivity, participants must have a negative Hep B viral load and an appropriate prophylaxis plan must be in place during chemotherapy therapy treatment. For all participants that have Hep B core antibody positive, they should take entecavir prophylaxis (0.5 mg PO daily) until 1 year from completion of chemotherapy. Hep B viral load should be checked on these participants prior to starting chemotherapy and every 3 months thereafter if initial Hep B viral load is negative (+/- 1 week if chemotherapy cycle is delayed). If Hep B viral load is positive, Hepatology or Identification (ID) referral is recommended, and hepatitis B virus (HBV) viral load should be checked monthly
  • For participants with hepatitis C Ab (HbcAb) positivity, a viral load must be checked and be negative for enrollment
  • Intrathecal chemotherapy for central nervous system prophylaxis only can be given at the discretion of the primary oncologist

Who cannot join

  • History of previous anthracycline exposure
  • Central Nervous System (CNS) or meningeal involvement at diagnosis
  • Creatinine Clearance <25 mL/min by body surface area (BSA)-adjusted Cockroft-Gault
  • Poor hepatic function, defined as total bilirubin concentration greater than 3.0 mg/dL or transaminases over 4 times the maximum normal concentration, unless these abnormalities are felt to be related to the lymphoma.
  • Pulmonary dysfunction defined as >2 L of oxygen required by nasal cannula to maintain peripheral capillary oxygen saturation (SpO2) ≥90% unless felt to be related to underlying lymphoma.
  • Myocardial Infarction within 6 months of enrollment
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  • Active, uncontrolled infectious disease
  • Known concurrent bone marrow malignancies (e.g. myelodysplastic syndrome) or poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 100×10⁹/L, unless caused by bone-marrow infiltration with lymphoma
  • History of a second concurrent active malignancy or prior malignancy which required chemotherapy treatment within the preceding 2 years
  • Treatment with any investigational drug within 30 days before the planned first cycle of chemotherapy
  • Unable or unwilling to sign consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: A Phase II Study of Split-Dose R-CHOP in Older Adults With Diffuse Large B-cell Lymphoma

This study is investigating a new administration schedule of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) chemotherapy for participants with Diffuse Large B-Cell Lymphoma (DLBCL), focusing on an underserved elderly population (aged 75 and up; certain participants 70-74 may be eligible) that is often excluded from clinical trials. Participants can expect to be on study for 2.5 years (treatment for 6 months and 2 years of post treatment follow-up).

Read the detailed description

This study will test the efficacy of split-dose R-CHOP for the treatment of elderly patients with de novo diagnosis of DLBCL or transformed DLBCL. Split-dose R-CHOP involves giving Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy at 14 days' interval with Rituximab given once/month. The safety for every 14-day CHOP administration was studied in a large prospective randomized control trial of patients up to the age of 80 years. In this study, R-CHOP given every 14 days for up to 6 cycles was felt to be the best method of delivery of chemotherapy. Receiving greater than 6 cycles of R-CHOP chemotherapy was not found to be beneficial compared to participants receiving 6 cycles of R-CHOP. Additionally, an interim response adapted approach by combining imaging and MRD testing will be used to identify participants who will receive an abbreviated chemotherapy course if they are both Positron Emission Tomography/Computed Tomography (PET/CT) and Minimum Residual Dose (MRD) negative.

In the proposed study, participants will receive a 50% dose reduction of CHOP chemotherapy on Day 1 and Day 15 of each cycle with full dose Rituximab on Day 1 for up to a total of 6 months of chemotherapy. Participants who are MRD and PET/CT negative after 2 months will be placed on an abbreviated regimen with R-CHOP x 4 additional doses with full dose Rituximab and a 50% dose reduction in CHOP chemotherapy. The hypothesis is that this method of administration of R-CHOP will be a safe and effective form of chemotherapy for older patients with DLBCL and will allow older patients to receive curative intent treatment.

Keywords
chemotherapy, cancer, elderly, lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Neoplasms, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Rituxan

    Rituximab is a monoclonal antibody

  • CyclophosphamideDrug

    Also called Cytoxan

    Chemotherapy drug, alkylating agent

  • DoxorubicinDrug

    Also called Adriamycin

    Chemotherapy drug, anthracycline antibiotic

  • VincristineDrug

    Chemotherapy drug, plant alkaloid

  • PrednisoneDrug

    Steroid, anti-inflammatory

  • PegfilgrastimBiological

    Also called filgrastim

    Granulocyte stimulating factor, biologic response modifier

Study groups in NCT03943901
Study groupRoleWhat they receive
Split Dose R-CHOPExperimentalEach cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles Day 1 ("A" part of cycle) * Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 1-5) PO * Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor. Day 15 ("B" part of cycle) * Cyclophosphamide 375 mg/m2 IV * Doxorubicin 25 mg/m2 IV * Vincristine 1 mg IV * Prednisone 50 mg (Days 15-19) PO * Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Biological: Pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CR)

    Simon 2-stage design with complete response (CR) rate at the end of treatment as our primary outcome. 40% is an unacceptable boundary for complete response rate and 60% as an acceptable complete response rate. CR at the end of treatment, will be estimated as the observed proportion and presented with a 95% Wilson confidence interval.

    Measured: up to 6 months

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    PFS measures survival without relapse/progression or death starting from study enrollment. Relapse or progression of disease and death will be considered as events; subjects who survive without recurrence or progression will be censored at last contact. PFS will be estimated using the Kaplan Meier estimate and presented with graphically with pointwise 95% confidence intervals.

    Measured: up to 2 years 6 months

  2. Overall Survival (OS)

    OS measures time to death starting from study enrollment. Death from any cause will be considered an event; surviving subjects will be censored at time of last follow-up. OS will be estimated using the Kaplan-Meier estimate and presented with graphically with pointwise 95% confidence intervals. Exploratory Cox proportional hazards regression will be used to evaluate the effect of baseline covariates on PFS and OS.

    Measured: up to 2 years 6 months

  3. Incidence of Treatment Emergent Serious Adverse Events

    The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment. The proportion of subjects experiencing a Serious Adverse Event (SAE) will be reported with 95% confidence intervals overall. Toxicity will be monitored using the formal boundary described in the protocol.

    Measured: up 6 months

  4. Summary of Treatment Emergent Serious Adverse Events by Grade and Organ System

    The incidence of serious adverse events will be reported for all subjects who received at least one dose of the study treatment.

    Measured: up 6 months

  5. Cancer-Specific Geriatric Assessment

    Cancer-specific geriatric assessment prior to, during, and after completion of chemotherapy treatments to evaluate for changes in physical function, mental health, cognition, and other relevant geriatric specific outcomes. The geriatric assessment measures will be summarized descriptively at each measurement time-point using appropriate descriptive statistics such as frequencies and percentages with standard errors for categorical variables, mean with standard error or median with quartiles for continuous variables.

    Measured: up to 2 years 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start17 Feb 2021
  3. Primary completion13 Jan 2025
  4. Study completionFeb 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943901
Sponsor's protocol ID
2019-0138
Other IDs
2019-0138, SMPH\MEDICINE\HEM-ONC, A534260, Protocol Version 7/21/2023, NCI-2020-01530
Status last verified
Aug 2026
First submitted
7 May 2019
Last updated
17 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Diffuse Large B Cell Lymphoma and DLBCL, run by University of Wisconsin, Madison 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 15 inclusion and 11 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 17 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 29 Jan 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?

Complete Response Rate (CR) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943901.

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 17 Aug 2026.

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