CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455897
Recruitment Status : Terminated (Accrual was too slow. Trial terminated)
First Posted : April 4, 2007
Last Update Posted : January 18, 2018
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Ephraim Hochberg, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Diffuse Drug: GM-CSF Drug: CHOP Drug: Rituximab Phase 2

Detailed Description:
  • Study treatment is divided into 21-day time periods called cycles. Almost all participants will be treated as outpatients unless they have an existing medical problem that requires them to be treated as in inpatient.
  • The drugs used in this study treatment are standard of care for this type of lymphoma and participants could receive these even if they are not taking part in the study.
  • Participants will start receiving GM-CSF 11 days before Day 1 of Cycle 1 for 10 days. They will receive the first dose of GM-CSF at the clinic. At least 1 1/2 days after the last GM-CSF injection (Day 1), they will receive chemotherapy (CHOP-R). Eleven days before they start the next cycle (Days 11-20), they will again start to receive GM-CSF injections for 10 days.
  • Participants will receive up to 6 cycles of study treatment if their disease is responding and they are tolerating the study treatment.
  • Additional medications may be given to prevent lung infection, return of brain and nervous system disease and tumor lysis syndrome.
  • Before beginning GM-CSF during each cycle of treatment blood will be drawn to monitor the participants health and to check for side effects.
  • On Day 1 of each cycle a physical examination and blood tests will be performed. On Day 7 and Day 14 of each cycle, routine blood tests will also be done.
  • After Cycle 2 and 4 CT scans of the neck, chest, abdomen and pelvis will be performed to check the status of the participants disease.
  • After 6 cycles of study treatment, the participant will return to the clinic for an End of Treatment Visit. At this visit a physical exam, routine blood tests, and CT scan of neck, chest, abdomen and pelvis will be performed.
  • The participant will be asked to return to the clinic every 3 months for the first year after study treatment and every 6 months up to 2 years after study treatment for the procedures outline in the End of Treatment Visit.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of CHOP-Rituximab Augmented With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma
Study Start Date : December 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: GMCSF-RCHOP Drug: GM-CSF
Given 11 days before day 1 of cycle 1 for 10 days

Drug: CHOP
Administered as part of standard care

Drug: Rituximab
Administered as part of standard treatment

Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To assess the response rate, 2-year event-free survival and overall survival with CM-CSF and CHOP-R in this patient population
  2. to analyze the biologic activity of GM-CSF at this dosing schedule and timing. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00455897

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Principal Investigator: Ephraim P Hochberg, MD Massachusetts General Hosptial

Responsible Party: Ephraim Hochberg, MD, Director Clinical Lymphoma Research, Massachusetts General Hospital Identifier: NCT00455897     History of Changes
Other Study ID Numbers: 05-342
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Ephraim Hochberg, MD, Massachusetts General Hospital:
granulocyte monocyte colony stimulating factor
Diffuse large B cell lymphoma
non-Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents