NCT00455897

Brief Summary

The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan, Adriamycin, Vincristine, Prednisone, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2006

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

April 2, 2007

Last Update Submit

January 16, 2018

Conditions

Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Diffuse

Keywords

granulocyte monocyte colony stimulating factorLeukineSargramostimDiffuse large B cell lymphomanon-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

  • To determine the safety of GM-CSF when administered in combination with CHOP-R to patients with previously untreated diffuse large B cell non-Hodgkin's lymphoma.

    2 years

Secondary Outcomes (2)

  • To assess the response rate, 2-year event-free survival and overall survival with CM-CSF and CHOP-R in this patient population

  • to analyze the biologic activity of GM-CSF at this dosing schedule and timing.

    2 years

Study Arms (1)

GMCSF-RCHOP

EXPERIMENTAL
Drug: GM-CSFDrug: CHOPDrug: Rituximab

Interventions

GM-CSFDRUG

Given 11 days before day 1 of cycle 1 for 10 days

GMCSF-RCHOP
CHOPDRUG

Administered as part of standard care

GMCSF-RCHOP
RituximabDRUG

Administered as part of standard treatment

GMCSF-RCHOP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of diffuse large B cell Non-Hodgkin's lymphoma with characteristic immunophenotypic profile
  • Patient has not received any prior anti-cancer therapy for lymphoma
  • Tumor tissue confirmed to express the cluster of differentiation antigen 20 antigen by flow cytometry or immunohistochemistry
  • Measurable disease as defined by a tumor mass of 1cm or greater in one dimension
  • Stage II (abdominal-not radiotherapy appropriate), III, or IV disease
  • Age \> 18 years
  • Performance Status of 0-2
  • Laboratory parameters as outlined in protocol
  • Patient agrees to use birth control

You may not qualify if:

  • Known central nervous system involvement by lymphoma
  • Serious uncontrolled concurrent illness such as active coronary artery disease, severe lung disease, heart failure, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
  • Any evidence of prior natural exposure to Hepatitis B
  • Active rheumatologic disease which may be exacerbated by GM-CSF
  • Cardiac ejection fraction less than 45%
  • Known HIV disease
  • Patient is pregnant or nursing
  • Patient is receiving other investigational drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Large B-Cell, Diffuse

Interventions

Granulocyte-Macrophage Colony-Stimulating FactorRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ephraim P Hochberg, MD

    Massachusetts General Hosptial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Clinical Lymphoma Research

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2007

Study Completion

July 1, 2011

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(3)