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A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk)


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk)


OBJECTIVES:

Primary

- Determine the complete response rate in patients with high- or high/intermediate-risk
diffuse large B-cell lymphoma treated with CODOX-M/IVAC comprising cyclophosphamide,
doxorubicin hydrochloride, vincristine sulfate, methotrexate, ifosfamide, etoposide
phosphate, and cytarabine with rituximab.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on days 1 and 11 and CODOX-M comprising doxorubicin
hydrochloride IV on day 1, cyclophosphamide IV on days 1-5, vincristine sulfate IV on days 1
and 8, methotrexate IV over 12 hours on day 10, and leucovorin calcium IV or orally every
3-6 hours beginning 24-36 hours after methotrexate. Patients also receive CNS prophylaxis
comprising cytarabine intrathecally (IT) on days 1 and 3 and methotrexate IT on day 15.
Patients with high-risk disease receive an additional dose of cytarabine IT on day 5 and
methotrexate IT on day 17. Patients also receive pegfilgrastim subcutaneously (SC) on day
11. Treatment repeats every 28 days for 2 courses in the absence of disease progression or
unacceptable toxicity.

After completion of CODOX-M course 1, patients receive rituximab IV on day 1** and IVAC
comprising etoposide phosphate IV over 1 hour and ifosfamide IV over 1 hour on days 1-5,
cytarabine IV over 3 hours (every 12 hours) on days 1 and 2, and methotrexate IT on day 5.
Patients with high-risk disease receive cytarabine IT on days 7 and 9. Patients also receive
pegfilgrastim SC on day 7. Treatment repeats every 28 days for 2 courses in the absence of
disease progression or unacceptable toxicity.

NOTE: **Patients with high-risk disease also receive rituximab IV on days 21 and 42 after
day 1 of course 4 (IVAC).

Treatment with R-CODOX-M and R-IVAC repeats every 28 days alternatively for 2 courses each
in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma

- International Prognostic Index (IPI) score high-intermediate (score = 3) OR high
(score = 4 or 5), defined as:

- Stage III or IV disease

- Raised lactic dehydrogenase and poor performance status (WHO performance
status 2-4)

- All morphological variants included

- B-cell nature of the proliferation must be verified by a positive anti-CD20
antibody (i.e., CD20-positive disease)

- No T-cell lymphoma

- No history of treated or non-treated indolent lymphoma

- Patients newly diagnosed who have large B-cell lymphoma with some small cell
infiltration in the bone marrow or lymph node may be allowed

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- Life expectancy > 3 months

- ANC > 1,500/mm^3*

- Platelet count > 100,000/mm^3*

- Serum creatinine < 150 μmol/L*

- Serum bilirubin < 35 μmol/L*

- AST and/or ALT < 2.5 times upper limit of normal* NOTE: *Unless attributed to bone
marrow infiltration by lymphoma.

- Fertile patients must use effective contraception

- Normal MUGA or echocardiogram without areas of abnormal contractility

- LVEF ≥ 50% and only tested if patient meets 1 of the following criteria:

- History of diabetes

- Prior cardiac disease, hypertension, or abnormal resting ECG

- No history of heart failure or uncontrolled angina pectoris

- No cardiac contraindication to doxorubicin hydrochloride (e.g., abnormal
contractility on echocardiography or MUGA)

- No neurological contraindication to vincristine sulfate (e.g., pre-existing diabetic
neuropathy)

- No concurrent uncontrolled medical condition

- No other serious active disease

- No general status that, according to the investigator, does not allow the
administration of 2 courses of CODOX-M/IVAC

- No active malignant disease within the past 10 years except curatively treated basal
or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix

- No positive serology for HIV or hepatitis B or C

- No medical or psychiatric conditions that compromise the patient's ability to give
informed consent

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy, radiotherapy, or other investigational drug for diffuse large
B-cell non-Hodgkin lymphoma

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Safety Issue:

No

Principal Investigator

A. McMillan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nottingham City Hospital NHS Trust

Authority:

Unspecified

Study ID:

CDR0000644893

NCT ID:

NCT00974792

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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