New split-dose chemo aims to help elderly lymphoma patients
NCT ID NCT03943901
First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study tests a modified schedule of standard chemotherapy (R-CHOP) for people aged 75 and older with diffuse large B-cell lymphoma, a type of blood cancer. The goal is to see if splitting the doses makes treatment easier to tolerate while still being effective. Twenty-seven participants will receive the split-dose regimen and be followed for about 2.5 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) with pegfilgrastim
- What this could lead to
- If successful, this split-dose schedule could offer a better-tolerated treatment option for older adults with DLBCL, potentially improving response rates and quality of life.
- What could go wrong
- This is a small, early-phase (phase II) study with only 27 participants, so results may not apply broadly. Chemotherapy side effects remain a risk, and the split-dose approach may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
27 people
The number who actually took part.
- Started
-
Feb 2021
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
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