Split-Dose R-CHOP for Older Adults With DLBCL
Diffuse Large B Cell Lymphoma, DLBCL, Cancer
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring chemotherapy, cancer, elderly, lymphoma
Eligibility Criteria
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
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
Sites / Locations
- University of Wisconsin Carbone Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Split Dose R-CHOP
Each 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.