Lymphoma, Non-HodgkinPhase 2NCT00455897
CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing GM-CSF, CHOP and Rituximab in people with Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Diffuse
- What is being tested?
- GM-CSF, CHOP and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2006to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Performance Status of 0-2
- Laboratory parameters as outlined in protocol
- Patient agrees to use birth control
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
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
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.
Read the 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.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Diffuse
- Being tested
- GM-CSF, CHOP, Rituximab
- Keywords
- granulocyte monocyte colony stimulating factor, Leukine, Sargramostim, Diffuse large B cell lymphoma, non-Hodgkin's lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
Given 11 days before day 1 of cycle 1 for 10 days
CHOPDrug
Administered as part of standard care
RituximabDrug
Administered as part of standard treatment
| Study group | Role | What they receive |
|---|---|---|
| GMCSF-RCHOP | Experimental | Not described Receives: Drug: GM-CSF; Drug: CHOP; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2007
- Study completionJul 2011
Why it stopped: Accrual was too slow. Trial terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Bayer
- Responsible party
- Principal investigator, Ephraim Hochberg, MD, Massachusetts General Hospital
- Investigators
- Ephraim P Hochberg, MD, Principal investigator, Massachusetts General Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455897
- Sponsor's protocol ID
- 05-342
- Status last verified
- Jan 2018
- First submitted
- 2 Apr 2007
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00455897
- Acronym / sponsor ID
- 05-342
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Diffuse
- Keywords
- granulocyte monocyte colony stimulating factor, Leukine, Sargramostim, Diffuse large B cell lymphoma, non-Hodgkin's lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual was too slow. Trial terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Bayer
- Study start
- Dec 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GMCSF-RCHOP | Experimental | Drug: GM-CSF, Drug: CHOP, Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-CSFGiven 11 days before day 1 of cycle 1 for 10 days | Drug | GMCSF-RCHOP |
| CHOPAdministered as part of standard care | Drug | GMCSF-RCHOP |
| RituximabAdministered as part of standard treatment | Drug | GMCSF-RCHOP |
Primary outcome
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 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Accrual was too slow. Trial terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ephraim P Hochberg, MD principal investigator
Massachusetts General Hosptial
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CSF, CHOP and Rituximab in people with Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Accrual was too slow. Trial terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.