LymphomaPhase 2NCT00499343
G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
A Phase 2 study testing Etoposide, G-CSF and GM-CSF in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Etoposide, G-CSF and GM-CSF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation.
- Age up to 70 years
- Platelet count > 100,000 mm3, independent of transfusion support
- Absolute neutrophil count (ANC) > 1500/mm3
- Zubrod performance status of 2 or less.
- Negative pregnancy test in women
- Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as defined by bilateral bone marrow aspirations and biopsies.
- Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C antibody.
Who cannot join
- Clinical or radiographic evidence of active CNS disease
- Severe concomitant medical or psychiatric illness
- Lactating or breast feeding females
- Less than 3 weeks from the first day of last chemotherapy
- Prior myeloablative therapy with autologous bone marrow or stem cell rescue
- Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.
Show all 10Show fewer
- Serum creatinine >1.6 mg/dl
- History of pelvic radiation
- Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation)
- Patients should not have received more than 6 cycles of fludarabine therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
Primary Objectives:
- To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
- To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups.
Secondary Objectives:
- To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging.
- To determine the incidence of disease progression/relapse at 12 months in the two groups.
Read the detailed description
Granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF) are synthetic (man-made) versions of substances naturally produced in your body. These substances, called colony stimulating factors, help the bone marrow to make new white blood cells. When certain cancer medicines fight your cancer cells, they also affect those white blood cells that fight infection. To help decrease the risk of infections when these cancer medicines are used, colony stimulating factors may be given. Colony stimulating factors are also used to help the bone marrow recover after bone marrow transplantation and stem cell transplantation. They are also used to increase the stem cell count in the blood so that adequate number of stem cells can be collected for purposes of transplantation.
Before the study begins, you will have a complete physical exam and have blood (around 1-2 tablespoons) and urine collected for routine tests. You will have x-rays and CT scans to check on the status of the disease. A sample of bone marrow will be collected for tests. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Your heart and lung function will be evaluated. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and either a echocardiogram or a multigated acquisition scan (MUGA) (these are tests that measure heart functions). You will also have lung function tests. Women who are able to have children must have a negative blood or urine pregnancy test.
You will have a plastic tube (central venous catheter - CVL) inserted under your collarbone. The CVL will be left in place for the duration of the treatment. The catheter will be used to deliver most of the drugs and for the collection and transfusion of the stem cells. When possible, all drugs that need to be given by vein will be given using the catheter.
All treatment will be given at M. D. Anderson. First, you will be given chemotherapy to increase the number of stem cells in your blood stream. This chemotherapy will include the drugs ifosfamide, etoposide, and rituximab. You will receive a higher dose of rituximab than is standard of care. The drug ifosfamide will be started on Day 2 and will be given as a continuous injection into a vein over 72 hours. The drug etoposide will also be started on Day 2 and will be given by vein over 2 hours every 12 hours. Rituximab will be given by vein over 4-6 hours on Days 1 and 8. To help decrease the risk of developing side effects caused by the chemotherapy, you will be given fluids by vein and a drug called mesna. Mesna will be given by vein over 24 hours after treatment with ifosfamide is finished. You will have to stay in the hospital for 4-6 days for this part of the treatment.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive G-CSF and GM-CSF. Participants in the other group will receive G-CSF alone.
After completion of chemotherapy, you will get GM-CSF and G-CSF or just G-CSF injections (given under the skin) twice a day. These drugs are given to help increase the number of white blood cells and will continue to be given until an adequate number of stem cells have been collected. During this time, you will have blood collected for tests (around 1 tablespoon) at least 3 times a week. If your doctor feels it is necessary, you may have blood collected more often.
Blood stem cells will be collected when your blood counts have returned to normal (about 10-16 days after the chemotherapy). The process of stem cell collection takes about 4 hours. It may take 1-6 sessions to collect the number of stem cells needed for the transplant. The process of stem cell collection is called apheresis. A machine is attached to the catheter under the collar bone and blood is withdrawn. The blood then flows through the machine, which removes stem cells from the blood. The blood is then returned back to you through the catheter. The stem cells are then frozen and stored. These stem cells will be given back to you after the next phase of treatment to help your blood counts recover after high dose chemotherapy. After enough stem cells have been collected, you will be admitted to the hospital for high dose chemotherapy.
You will have check-up visits at various times over the next year as part of your standard evaluation after transplantation to check on the status of the disease.
This is an investigational study. All of the drugs used in this study are FDA approved and are commercially available. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Etoposide, G-CSF, GM-CSF, Isophosphamide, Rituximab, Ifosfamide, Sargramostim, Leukine, Filgrastim, Neupogen, Apheresis, Stem Cell Collection
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called Vepesid
150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses.
G-CSFDrug
Also called Filgrastim, Neupogen
Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
GM-CSFDrug
Also called Sargramostim, Leukine
250 mcg/m^2 injection given every evening till the completion of apheresis.
IsophosphamideDrug
Also called ifosfamide, Ifex
10 g/m^2 given intravenously continuous infusion over 72 hours.
RituximabDrug
Also called Rituxan
Days +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously.
ApheresisProcedure or surgery
Peripheral blood stem cell collection.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab + Ifosfamide + Etoposide + 2 Growth Factors | Experimental | Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF) Receives: Drug: Etoposide; Drug: G-CSF; Drug: GM-CSF; Drug: Isophosphamide; Drug: Rituximab; Procedure: Apheresis |
| Rituximab + Ifosfamide + Etoposide + 1 Growth Factor | Experimental | Growth Factor = granulocyte-colony stimulating factor (G-CSF) Receives: Drug: Etoposide; Drug: G-CSF; Drug: Isophosphamide; Drug: Rituximab; Procedure: Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD34+ Cells/kg in Blood Stem Cells
After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.
Measured: The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJan 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499343
- Sponsor's protocol ID
- ID03-0242
- Status last verified
- Jun 2013
- First submitted
- 9 Jul 2007
- Last updated
- 2 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hosing C, Munsell MF, Reuben JM, Popat U, Lee BN, Gao H, Korbling M, Shpall EJ, Kebriaei P, Alousi A, De Lima M, McMannis J, Qazilbash M, Anderlini P, Giralt S, Champlin RE, Khouri I. A randomized study comparing chemotherapy followed by G-CSF alone or in combination with GM-CSF for mobilization of peripheral blood stem cells in patients with non-Hodgkin's lymphomas. J Blood Med. 2010;1:49-55. doi: 10.2147/JBM.S9846. Epub 2010 Apr 14.
PubMed 22282683
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00499343
- Acronym / sponsor ID
- ID03-0242
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Etoposide, G-CSF, GM-CSF, Isophosphamide, Rituximab, Ifosfamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jan 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Posted 7 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
- To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups.
Secondary Objectives:
- To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging.
- To determine the incidence of disease progression/relapse at 12 months in the two groups.
Detailed description
Granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF) are synthetic (man-made) versions of substances naturally produced in your body. These substances, called colony stimulating factors, help the bone marrow to make new white blood cells. When certain cancer medicines fight your cancer cells, they also affect those white blood cells that fight infection. To help decrease the risk of infections when these cancer medicines are used, colony stimulating factors may be given. Colony stimulating factors are also used to help the bone marrow recover after bone marrow transplantation and stem cell transplantation. They are also used to increase the stem cell count in the blood so that adequate number of stem cells can be collected for purposes of transplantation.
Before the study begins, you will have a complete physical exam and have blood (around 1-2 tablespoons) and urine collected for routine tests. You will have x-rays and CT scans to check on the status of the disease. A sample of bone marrow will be collected for tests. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Your heart and lung function will be evaluated. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and either a echocardiogram or a multigated acquisition scan (MUGA) (these are tests that measure heart functions). You will also have lung function tests. Women who are able to have children must have a negative blood or urine pregnancy test.
You will have a plastic tube (central venous catheter - CVL) inserted under your collarbone. The CVL will be left in place for the duration of the treatment. The catheter will be used to deliver most of the drugs and for the collection and transfusion of the stem cells. When possible, all drugs that need to be given by vein will be given using the catheter.
All treatment will be given at M. D. Anderson. First, you will be given chemotherapy to increase the number of stem cells in your blood stream. This chemotherapy will include the drugs ifosfamide, etoposide, and rituximab. You will receive a higher dose of rituximab than is standard of care. The drug ifosfamide will be started on Day 2 and will be given as a continuous injection into a vein over 72 hours. The drug etoposide will also be started on Day 2 and will be given by vein over 2 hours every 12 hours. Rituximab will be given by vein over 4-6 hours on Days 1 and 8. To help decrease the risk of developing side effects caused by the chemotherapy, you will be given fluids by vein and a drug called mesna. Mesna will be given by vein over 24 hours after treatment with ifosfamide is finished. You will have to stay in the hospital for 4-6 days for this part of the treatment.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive G-CSF and GM-CSF. Participants in the other group will receive G-CSF alone.
After completion of chemotherapy, you will get GM-CSF and G-CSF or just G-CSF injections (given under the skin) twice a day. These drugs are given to help increase the number of white blood cells and will continue to be given until an adequate number of stem cells have been collected. During this time, you will have blood collected for tests (around 1 tablespoon) at least 3 times a week. If your doctor feels it is necessary, you may have blood collected more often.
Blood stem cells will be collected when your blood counts have returned to normal (about 10-16 days after the chemotherapy). The process of stem cell collection takes about 4 hours. It may take 1-6 sessions to collect the number of stem cells needed for the transplant. The process of stem cell collection is called apheresis. A machine is attached to the catheter under the collar bone and blood is withdrawn. The blood then flows through the machine, which removes stem cells from the blood. The blood is then returned back to you through the catheter. The stem cells are then frozen and stored. These stem cells will be given back to you after the next phase of treatment to help your blood counts recover after high dose chemotherapy. After enough stem cells have been collected, you will be admitted to the hospital for high dose chemotherapy.
You will have check-up visits at various times over the next year as part of your standard evaluation after transplantation to check on the status of the disease.
This is an investigational study. All of the drugs used in this study are FDA approved and are commercially available. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab + Ifosfamide + Etoposide + 2 Growth Factors | Experimental | Drug: Etoposide, Drug: G-CSF, Drug: GM-CSF, Drug: Isophosphamide, Drug: Rituximab, Procedure: ApheresisGrowth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF) |
| Rituximab + Ifosfamide + Etoposide + 1 Growth Factor | Experimental | Drug: Etoposide, Drug: G-CSF, Drug: Isophosphamide, Drug: Rituximab, Procedure: ApheresisGrowth Factor = granulocyte-colony stimulating factor (G-CSF) |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation.
- Age up to 70 years
- Platelet count > 100,000 mm3, independent of transfusion support
- Absolute neutrophil count (ANC) > 1500/mm3
- Zubrod performance status of 2 or less.
Key exclusion criteria (10 listed)
- Clinical or radiographic evidence of active CNS disease
- Severe concomitant medical or psychiatric illness
- Lactating or breast feeding females
- Less than 3 weeks from the first day of last chemotherapy
- Prior myeloablative therapy with autologous bone marrow or stem cell rescue
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 |
|---|---|---|
| EtoposideAlso: Vepesid150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses. | Drug | Rituximab + Ifosfamide + Etoposide + 1 Growth Factor, Rituximab + Ifosfamide + Etoposide + 2 Growth Factors |
| G-CSFAlso: Filgrastim, NeupogenStarting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis. | Drug | Rituximab + Ifosfamide + Etoposide + 1 Growth Factor, Rituximab + Ifosfamide + Etoposide + 2 Growth Factors |
| GM-CSFAlso: Sargramostim, Leukine250 mcg/m^2 injection given every evening till the completion of apheresis. | Drug | Rituximab + Ifosfamide + Etoposide + 2 Growth Factors |
| IsophosphamideAlso: ifosfamide, Ifex10 g/m^2 given intravenously continuous infusion over 72 hours. | Drug | Rituximab + Ifosfamide + Etoposide + 1 Growth Factor, Rituximab + Ifosfamide + Etoposide + 2 Growth Factors |
| RituximabAlso: RituxanDays +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously. | Drug | Rituximab + Ifosfamide + Etoposide + 1 Growth Factor, Rituximab + Ifosfamide + Etoposide + 2 Growth Factors |
| ApheresisPeripheral blood stem cell collection. | Procedure or surgery | Rituximab + Ifosfamide + Etoposide + 1 Growth Factor, Rituximab + Ifosfamide + Etoposide + 2 Growth Factors |
Primary outcome
CD34+ Cells/kg in Blood Stem Cells
Time frame: The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.
After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22282683Hosing C, Munsell MF, Reuben JM, Popat U, Lee BN, Gao H, Korbling M, Shpall EJ, Kebriaei P, Alousi A, De Lima M, McMannis J, Qazilbash M, Anderlini P, Giralt S, Champlin RE, Khouri I. A randomized study comparing chemotherapy followed by G-CSF alone or in combination with GM-CSF for mobilization of peripheral blood stem cells in patients with non-Hodgkin's lymphomas. J Blood Med. 2010;1:49-55. doi: 10.2147/JBM.S9846. Epub 2010 Apr 14.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Chitra M. Hosing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide, G-CSF and GM-CSF in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 7 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CD34+ Cells/kg in Blood Stem Cells (time frame: The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00499343, which also lists 1 linked publication.
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 2 Aug 2013.