Clinical trial NCT01054781: Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
Official title: Open-labelled, Multicenter Phase II Study of Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
Keywords: Diffuse Large B-Cell Lymphoma (DLBCL)
rituximab
CHOP
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL


Eligibility criteria: Inclusion criteria

1. Histologically confirmed CD20 positive Diffuse Large B-cell Lymphoma (DLBCL)
2. Advanced stage: stage III, IV and/or bulky disease (largest diameter ≥ 10.0 cm) regardless of stage
3. Previously untreated.
4. Performance status: ECOG 0-2.
5. Age ≥ 18
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 2D ECHO 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 hematological function: 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 ≥ 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 \< 1 years after the onset of menopause.
13. Informed consent

Exclusion criteria

1. Other subtypes NHL than DLBCL
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

   * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
   * History of significant neurological or psychiatric disorders including dementia or seizures
   * Active uncontrolled infection (viral, bacterial or fungal infection)
   * 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.

Primary outcomes:
measure: To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the overall response rate of R+R-CHOP
timeFrame: 12 months
measure: To evaluate the duration of overall response
timeFrame: 12 months
measure: To evaluate the safety and tolerability of the R+R-CHOP combination treatment.
timeFrame: 12 months
measure: To evaluate the progression free survival.
timeFrame: 12 months
measure: To estimate the overall survival.
timeFrame: 12 months
measure: To explore prognostic or predictive biomarkers
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: WonSeog Kim, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: