Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.

Non-Hodgkin Lymphoma Clinical Trial

Official title:

Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00429065
• Other study ID #: Hemato INCAN 01/2007
• Status: Recruiting
• Phase: Phase 4
• First received: January 30, 2007
• Last updated: January 30, 2007
• Start date: January 2007
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: Silvia Rivas-Vera, MD
• Phone: 56 28 04 46
• Email: srivasv02[@]yahoo.com.mx
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.

Description:

Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative lymphoma are more sensitive to Rituximab therapy. It is also known that patients with high-intermediate and high IPI risk does not benefit form standard three weekly CHOP chemotherapy.

In this study we intend to define a subgroup of patients in whom this therapy will be of maximum benefit.

We will prospectively treat a group of patients with the following characteristics:

< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment regimen: R-CHOP (standard dosis) for 8 cycles

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Large B cell Non-Hodgkin Lymphoma CD20+

• BCL-6 negative

• Age < 61 years old

• ECOG 2 or less

• IPI low, low intermediate

• Stage II, III or IV

• Signed Informed Consent

Exclusion Criteria:

• Stage I

• Previous treatment

• Lymphomatous central nervous system involvement

• Heart disease

• Kidney failure (serum creatinine > 2 mg/dl)

• HIV +

• Viral Hepatitis

• Pregnancy

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerologia	Mexico City	D.f.

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Lossos IS, Czerwinski DK, Alizadeh AA, Wechser MA, Tibshirani R, Botstein D, Levy R. Prediction of survival in diffuse large-B-cell lymphoma based on the expression of six genes. N Engl J Med. 2004 Apr 29;350(18):1828-37. — View Citation

Lossos IS, Jones CD, Warnke R, Natkunam Y, Kaizer H, Zehnder JL, Tibshirani R, Levy R. Expression of a single gene, BCL-6, strongly predicts survival in patients with diffuse large B-cell lymphoma. Blood. 2001 Aug 15;98(4):945-51. — View Citation

Winter JN, Weller EA, Horning SJ, Krajewska M, Variakojis D, Habermann TM, Fisher RI, Kurtin PJ, Macon WR, Chhanabhai M, Felgar RE, Hsi ED, Medeiros LJ, Weick JK, Reed JC, Gascoyne RD. Prognostic significance of Bcl-6 protein expression in DLBCL treated with CHOP or R-CHOP: a prospective correlative study. Blood. 2006 Jun 1;107(11):4207-13. Epub 2006 Jan 31. Erratum in: Blood. 2007 Mar 15;109(6):2292. — View Citation