CClinicalTrials.gg
Status unknownNCT00429065Updated Jan 31, 2007

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

An observational study in Non-Hodgkin Lymphoma, sponsored by Instituto Nacional de Cancerologia de Mexico. Status unknown at 1 site in Mexico. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2007-01-31.

Sponsored by Instituto Nacional de Cancerologia de Mexico · Observational

The sponsor has not verified this record recently (last verified Jan 2007), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
30
Ages
15 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Non-Hodgkin Lymphoma

Keywords

  • Non-Hodgkin lymphoma
  • rituximab
  • immunotherapy
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 30 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Instituto Nacional de Cancerologia de Mexico is the lead sponsor of 41 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Stage I
  • Previous treatment
  • Lymphomatous central nervous system involvement
  • Heart disease
  • Kidney failure (serum creatinine > 2 mg/dl)
  • HIV +
  • Viral Hepatitis
  • Pregnancy
05

Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
30 participants

Interventions

  • DrugRituximab
06

Study locations

1 of 1 sites recruiting
  • Instituto Nacional de Cancerologia
    Mexico City, D.f. 14080, Mexico
    Recruiting
07

References and documents

Publications

  • 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. Erratum In: Blood. 2007 Mar 15;109(6):2292. PubMed 16449523 ↗
  • 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. PubMed 11493437 ↗
  • 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. PubMed 15115829 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00429065
Lead sponsor
Instituto Nacional de Cancerologia de Mexico
First posted
Jan 31, 2007
Start date
Jan 2007
Completion
Jan 2007
Last update
Jan 31, 2007

Study contacts

Silvia Rivas-Vera, MD
Contact
srivasv02@yahoo.com.mx
56 28 04 46
Pedro Sobrevilla-Calvo, MD
Contact
sobrevilla.pedro@gmail.com
56 28 04 16
Pedro Sobrevilla-Calvo, MD
principal investigator · Instituto Nacional de Cancerologia Mexico
Silvia Rivas-Vera, MD
principal investigator · Instituto Nacional de Cancerologia Mexico
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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