Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)

Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054781
• Other study ID #: 2008-12-005
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2010
• Last updated: September 26, 2012
• Start date: January 2009

Study information

• Verified date: September 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
1st cycle R+R-CHOP 2-8th cycle R-CHOP

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and		12 months	Yes
Secondary	To evaluate the overall response rate of R+R-CHOP		12 months	Yes
Secondary	To evaluate the duration of overall response		12 months	Yes
Secondary	To evaluate the safety and tolerability of the R+R-CHOP combination treatment.		12 months	Yes
Secondary	To evaluate the progression free survival.		12 months	Yes
Secondary	To estimate the overall survival.		12 months	Yes
Secondary	To explore prognostic or predictive biomarkers		12 months	Yes