Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Diffuse

Thank you

Trial Information

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 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.

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 CD20 antigen by flow cytometry or

- Measurable disease as defined by a tumor mass of 1cm or greater in one dimension

- Stage II (abdominal-not XRT appropriate), III, or IV disease

- Age > 18 years

- ECOG 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 COPD, CHF, 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ephraim P Hochberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hosptial


United States: Institutional Review Board

Study ID:




Start Date:

December 2006

Completion Date:

July 2011

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Diffuse
  • GM-CSF
  • CHOP-R
  • Leukine
  • Sargramostim
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617