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

January 16, 2018 updated by: Ephraim Hochberg, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Bayer
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Ephraim P Hochberg, MD, Massachusetts General Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (ESTIMATE)

April 4, 2007

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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