Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over

NCT02792491 | Unknown Phase 2

• 1 other identifier: Elderly RD_R-CHOP
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 3 year progression free survival rate

  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 (3)

• Overall response rate

  Until the disease progression (maximum 3 years after completion of treatment, assessed up to 36 months(

• Overall survival

  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

  From the date of first drug administration until the date of the 30th days

Study Arms (1)

Reduced dose R-CHOP

EXPERIMENTAL

Reduced dose R-CHOP is regimen including Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. In this study, Rituximab 375 mg/m2, Cyclophosphamide 600 mg/m2, Doxorubicin 30 mg/m2 and Vincristine fixed dose of 1mg will be administrated through intravenous on day 1. and Prednisone 40mg will be administrated orally on day 1-5. This chemotherapy will be repeated every 21 days.

Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Interventions

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone DRUG

Reduced dose of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Also known as: R-CHOP

Reduced dose R-CHOP

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed CD20 positive DLBCL
• Age ≥ 65 years
• Ann Arbor stage II, III and IV
• No prior chemotherapy or radiotherapy for DLBCL
• Performance status (ECOG) ≤ 2
• At least one or more bidimensionally measurable lesion(s)
• cm by conventional CT
• cm by spiral CT skin lesion (photographs should be taken) ≥ 2 cm measurable lesion by physical examination ≥ 2 cm
• Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2DECHO without clinically significant abnormalities
• Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
• 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)
• 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
• Life expectancy more than 6 months
• 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.

You may not qualify if:

• Other subtypes NHL than DLCBL
• Patients who transformed follicular lymphoma or other indolent lymphoma
• Primary Central Nervous System (CNS) DLBCL
• 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.
• 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.
• Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• 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
• Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

Sponsors & Collaborators

• Pusan National University Hospital: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; R-CHOP protocol

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Ho-Jin Ho-Jin

  Pusan National University Hospital

  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: Division of hematology-oncology

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: August 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 9, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share