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

NCT01279902 | Unknown Phase 2

• 1 other identifier: AMC_NHL01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

diffuse large B-cell lymphoma; rituximab; CHOP; abbreviated therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL

  2 years

Secondary Outcomes (2)

• Overall survival

  2 years

• any adverse events as a measure of safety and tolerability

  from the first R-CHOP to 1 month after completion of R-CHOP

Study Arms (1)

Rituximab plus CHOP Immunochemotherapy

EXPERIMENTAL

Interventions: conventional R-CHOP every 3 weeks for 3 cycles * Rituximab 375 mg/M2 IV day 1 * Cyclophosphamide 750 mg/M2 IV day1 * Vincristine 1.5 mg/M2 (max. 2 mg) IV day1 * Prednisolone 50 mg bid day 1-5, every 3 weeks

Drug: Rituximab plus CHOP Immunochemotherapy

Interventions

Rituximab plus CHOP Immunochemotherapy DRUG

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).

Rituximab plus CHOP Immunochemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Kang S, Cho H, Sohn BS, Oh SY, Lee WS, Lee SM, Yang DH, Huh J, Yoon DH, Suh C. Long-term follow-up of abbreviated R-CHOP chemoimmunotherapy for completely resected limited-stage diffuse large B cell lymphoma (CISL 12-09). Ann Hematol. 2020 Dec;99(12):2831-2836. doi: 10.1007/s00277-020-04284-z. Epub 2020 Sep 28.

  PMID: 32989495 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Cheolwon Suh, MD, PhD

  Asan Mecical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: January 20, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)