Know Cancer

or
forgot password

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)


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Lymphoma, Large B-cell, Diffuse

Thank you

Trial Information

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)


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the overall response rate

Outcome Description:

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.

Outcome Time Frame:

three years after the completion of rituximab augmentation

Safety Issue:

Yes

Authority:

Korea:Korean Food and Drug Administration (KFDA)

Study ID:

ML25393

NCT ID:

NCT01181999

Start Date:

August 2010

Completion Date:

September 2014

Related Keywords:

  • Lymphoma, Large B-Cell, Diffuse
  • diffuse large B-cell lymphoma
  • elderly patients
  • rituximab augmentation
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location