Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

Lymphoma, Large B-cell, Diffuse Clinical Trial

Official title:

Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01181999
• Other study ID #: ML25393
• Status: Recruiting
• Phase: Phase 2
• First received: August 11, 2010
• Last updated: September 21, 2011
• Start date: August 2010
• Est. completion date: September 2014

Study information

• Verified date: July 2010
• Source: Chonnam National University Hospital
• Contact: Deok-Hwan Yang, M.D. and Ph.D.
• Phone: 82-61-379-7636
• Email: drydh1685[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea:Korean Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).

The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.

Description:

1. Four cycles of R-CHOP chemotherapy for the induction treatment [Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)]

If patients with CCI <1

• Rituximab: 375 mg/m2, day 1 every 3 weeks.

• Conventional dose of CHOP chemotherapy repeat every 3 weeks.

If patients with CCI ≥1

• Rituximab: 375 mg/m2, day 1 every 3 weeks.

• 75% of conventional CHOP repeat every 3 weeks.

2. Rituximab augmentation

• Rituximab: 375 mg/m2, every week x 4 times.

• Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed CD20 positive DLBCL

2. Age = 70

3. Ann Arbor stage II, III and IV

4. No prior chemotherapy or radiotherapy for DLBCL

5. Performance status (Eastern Cooperative Oncology Group) = 2

6. At least one or more bidimensionally measurable lesion(s)

• = 2 cm by conventional computerized tomography (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 echocardiogram without clinically significant abnormalities

8. Adequate renal function: serum creatinine level < 2 mg/dL (177 µmol/L)

9. Adequate liver functions:

10. Adequate bone marrow functions:

hemoglobin = 9 g/dL absolute neutrophil count = 1,500/µL and platelet count = 75,000/µL, unless abnormalities are due to bone marrow involvement by lymphoma

11. Life expectancy more than 6 months

12. Informed consent

Exclusion Criteria:

1. Other subtypes of non-Hodgkin's lymphoma

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.

5. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• rituximab
A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hosptial	Jeollanam-do

Sponsors (4)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Asan Medical Center, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall response rate	To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.	three years after the completion of rituximab augmentation	Yes
Primary	Number of patients with adverse events	All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0).	three years	Yes
Secondary	progression-free survival		Three years after the completion of rituximab augmentation	Yes