Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I or II CD20+ Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01279902
• Other study ID #: AMC_NHL01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 3, 2010
• Last updated: July 25, 2016
• Start date: August 2010
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.

Description:

Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I or II DLBCL would be treated with surgical resection followed by chemotherapy in this trial. While chemotherapy is the main treatment modality and radiotherapy becomes adjuvant treatment in the former treatment scheme, surgical resection will remove all the gross lesions and chemotherapy aims to remove all microscopic disease whichever exists in the latter treatment scheme. Currently, six cycles of chemotherapy is usually performed after surgery even without any residual lesion compared with three cycles of chemotherapy in the former treatment scheme which plays primary role in the treatment scheme. The investigators will investigate whether abbreviated 3 cycles of Rituximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone (R-CHOP) immunochemotherapy following complete resection is an effective and safe treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who underwent curative resection of primary tumor

• Pathologically confirmed CD20 positive diffuse large B-cell lymphoma (DLBCL) after surgical resection

• Ann Arbor Stage I or II

• No history of chemotherapy

• Performance status: ECOG 0-2

• Age: 18 to 70 years old

• Complete excision with negative resection margin on pathologic report after surgery

• Cardiac ejection fraction = 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities

• Adequate renal function: serum creatinine level below 2 mg/dL (177µmol/L)

• Adequate liver functions: Transaminase (AST/ALT) < 3X upper normal value, Bilirubin < 2X upper normal value

• Adequate hematologic function: hemoglobin = 9 g/dL, absolute neutrophil count (ANC) = 1,500/mm3 and platelet count = 75,000/mm3

• Informed consent

Exclusion Criteria:

• Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients are eligible if primary prophylaxis is given

• Previous or concurrent cancer that is distinct in primary site or histology from DLBCL, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• Other serious illness or medical conditions

1. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry

2. History of significant neurological or psychiatric disorders including dementia or seizures

3. Active uncontrolled infection (viral, bacterial or fungal infection)

4. Other serious medical illnesses

• Known hypersensitivity to any of the study drugs or their ingredients

• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

• Patient with B symptoms or Bulky disease

Study Design

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab plus CHOP Immunochemotherapy
The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL	2 years	No
Secondary	Overall survival	proportion of patients surviving at 2 year after first cycle of R-CHOP chemotherapy regardless of relapse of DLBCL	2 years	No
Secondary	any adverse events as a measure of safety and tolerability	The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.	from the first R-CHOP to 1 month after completion of R-CHOP	Yes