This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma
Treatment reduced dose r-chop
Phase phase 2
Sponsor Pusan National University Hospital
Start date August 2012
End date December 2017
Trial size 57 participants
Trial identifier NCT02792491, Elderly RD_R-CHOP


This is Phase II prospective trial of addition of rituximab to reduced dose CHOP chemotherapy in DLBC L patients aged 65 years and over.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Rituximab 375 mg/m2, Cyclophosphamide 600 mg/m2, Doxorubicin 30 mg/m2 and Vincristine fixed dose of 1mg iv on day 1. and Prednisone 40mg orally on day 1-5. This chemotherapy will be repeated every 21 days.
reduced dose r-chop Rituximab,Cyclophosphamide,Doxorubicin,Vincristine,Prednisone
Reduced dose of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Primary Outcomes

3 year progression free survival rate
time frame: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months

Secondary Outcomes

Overall response rate
time frame: Until the disease progression (maximum 3 years after completion of treatment, assessed up to 36 months(
Overall survival
time frame: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months
Toxicity profile
time frame: From the date of first drug administration until the date of the 30th days

Eligibility Criteria

Male or female participants up to 65 years old.

Inclusion Criteria: 1. Histologically confirmed CD20 positive DLBCL 2. Age ≥ 65 years 3. Ann Arbor stage II, III and IV 4. No prior chemotherapy or radiotherapy for DLBCL 5. Performance status (ECOG) ≤ 2 6. At least one or more bidimensionally measurable lesion(s) - 2 cm by conventional CT - 1 cm by spiral CT skin lesion (photographs should be taken) ≥ 2 cm measurable lesion by physical examination ≥ 2 cm 7. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2DECHO without clinically significant abnormalities 8. Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L) 9. Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver) Bilirubin < 2 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver) 10. Adequate BM functions: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma 11. Life expectancy more than 6 months 12. A negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 1years after the onset of menopause. 13. Informed consent Exclusion Criteria: 1. Other subtypes NHL than DLCBL 2. Patients who transformed follicular lymphoma or other indolent lymphoma 3. Primary Central Nervous System (CNS) DLBCL 4. CNS involvement by lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) in case of clinical suspicion of CNS involvement by lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible. 5. Patients with a known history of HIV seropositivity or HCV (+). Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period. 6. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 7. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 8. Other serious illness or medical conditions i. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry ii. History of significant neurologic or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses 9. Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies) 10. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

Additional Information

Official title Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over
Principal investigator Ho-Jin Ho-Jin
Description The body surface area(BSA) on the date of every treatment cycle may be used as the same value of baseline BSA, if change of body weight is within 10% of baseline body weight. But, if there is a change of body weight more than 10% that of baseline, BSA should be recalculated. It will be repeated every 21 days. But the change of starting date of subsequent cycle and laboratory or radiologic tests may be allowed within 4 days from the scheduled date or delay due to toxicities. The RD-RCHOP treatment will be continued up to 6-8 cycles (or 3 cycles in case of stable disease(SD) or progressive disease(PD) after the first 3cycles) with duration of 21 days. Visit windows ± 4days in Treatment period.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Pusan National University Hospital.