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

NCT ID: NCT00429065

Last Updated: 2007-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Non-Hodgkin Lymphoma

Keywords

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Non-Hodgkin lymphoma rituximab immunotherapy

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Rituximab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role lead

Principal Investigators

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Pedro Sobrevilla-Calvo, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia Mexico

Silvia Rivas-Vera, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia Mexico

Locations

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Instituto Nacional de Cancerologia

Mexico City, D.F., Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Silvia Rivas-Vera, MD

Role: CONTACT

Phone: 56 28 04 46

Email: [email protected]

Pedro Sobrevilla-Calvo, MD

Role: CONTACT

Phone: 56 28 04 16

Email: [email protected]

References

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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. doi: 10.1182/blood-2005-10-4222. Epub 2006 Jan 31.

Reference Type BACKGROUND
PMID: 16449523 (View on PubMed)

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. doi: 10.1182/blood.v98.4.945.

Reference Type BACKGROUND
PMID: 11493437 (View on PubMed)

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. doi: 10.1056/NEJMoa032520.

Reference Type BACKGROUND
PMID: 15115829 (View on PubMed)

Other Identifiers

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Hemato INCAN 01/2007

Identifier Type: -

Identifier Source: org_study_id