Non-Hodgkin's LymphomaPhase 3NCT01103388
Rituximab Maintenance After Autologous Transplantation
A Phase 3 study testing Rituximab in people with Non-Hodgkin's Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Apr 2010
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present.
- Absolute neutrophil count (ANC) > 1500/mm3 independent of growth factor support
- No evidence of symptomatic cardiac or pulmonary disease
- Platelet count > 75,000 mm3
- Zubrod performance status of 2 or less.
- Negative pregnancy test in patients of "child bearing potential"
Who cannot join
- Uncontrolled active infection
- Severe concomitant medical or psychiatric illness
- Serum bilirubin > 2.0 mg/dl 4) Transaminases > 2xULN 5) Serum creatinine > 2.0 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintenance Therapy With Rituximab After Autologous Transplantation for Non-Hodgkin's Lymphoma
The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the lymphoma.
Read the detailed description
Rituxan is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein (which is found on the surface of normal and cancerous B-lymphocytes). This binding may help to destroy the B-lymphocytes.
Before the study begins, you will have a physical exam, routine blood tests (1-2 tablespoons), and urine tests. Women who are able to have children must have a negative blood pregnancy test. You will also have a chest x-ray and an ECG (test to measure the electrical activity of the heart). The status of the lymphoma will be evaluated by bone marrow biopsy. 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. CT scans and gallium or PET scans will be performed. If you had lymphoma in other areas of your body additional tests may be needed as determined by your treating physician. Tests to evaluate the status of the lymphoma will be repeated before each cycle of chemotherapy. If your white count is low you may need injections of NeupogenTM (growth factor) daily till your white blood cell count is high enough to start the next round of 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 rituximab. Participants in the other group will not receive rituximab. There is an equal chance of being assigned to either group.
Treatment will start between 5-6 months after your stem cell transplant. If you are assigned to the rituximab group, you will receive a total of 4 cycles of treatment. Each cycle will be given 6 months apart. Each cycle is made up of 4 doses of rituximab given once a week for 4 weeks. If the disease returns or intolerable side effects occur while on treatment, you will be taken off the study. You may still be able to receive rituximab outside of this study if your treating physician decided that it is okay.
Treatment will be given on an outpatient basis. The treatment can be given at M. D. Anderson or by your local cancer doctor. Patients who are assigned to the rituximab arm must be willing to get their first and third cycle (all 4 doses) at M. D. Anderson, if their local physician is unable to draw and ship samples to the central laboratory for rituximab levels. Blood will be drawn (approximately one teaspoon) before and after the first and fourth dose and before the second and third dose of those two treatment cycles. The treatment will be given by vein over a period of several hours. Participants who have easily accessible veins may get this treatment by having a temporary needle placed in the vein for the treatment. For participants who do not have easily accessible veins, a central venous catheter (long plastic tube - CVL) will be placed in a big vein of the arm or chest.
Participants who do not receive rituximab will be followed every 6 months at M. D. Anderson as is standard of care.
All participants (even those who do not receive the rituximab) will have to return to M. D. Anderson every 6 months for a period of 3 years (from the date of enrollment) to have the lymphoma evaluated. The status of the lymphoma will be evaluated by blood tests (1-2 tablespoons), CT scans, PET or Gallium scans and bone marrow biopsy.
This is an investigational study. Rituximab has been approved by the FDA. About 90 patients will take part in the study. All will be enrolled at M. D. Anderson.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Rituximab
- Keywords
- Rituximab, Rituxan, Lymphoma, High dose chemotherapy, Autologous transplantation, Autologous stem cell transplant, ASCT
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
375 mg/m^2 by vein (IV) in 4 weekly doses (1 cycle) every 6 months for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Not described Receives: Drug: Rituximab |
| No Rituximbab | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Progression Free Survival (PFS)
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 posted14 Apr 2010 (estimated)
- Study startAug 2003
- Primary completionApr 2006
- Study completionApr 2010
Why it stopped: Closed early due to slow patient accrual and sponsor's withdrawal of support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103388
- Sponsor's protocol ID
- ID03-0239
- Status last verified
- Jul 2012
- First submitted
- 12 Apr 2010
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy With Rituximab After Autologous Transplantation for Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01103388
- Acronym / sponsor ID
- ID03-0239
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Rituximab, Rituxan, Lymphoma, High dose chemotherapy, Autologous transplantation, Autologous stem cell transplant, ASCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early due to slow patient accrual and sponsor's withdrawal of support.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Apr 2010 (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 goal of this clinical research is to see if Rituxan (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the lymphoma.
Detailed description
Rituxan is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein (which is found on the surface of normal and cancerous B-lymphocytes). This binding may help to destroy the B-lymphocytes.
Before the study begins, you will have a physical exam, routine blood tests (1-2 tablespoons), and urine tests. Women who are able to have children must have a negative blood pregnancy test. You will also have a chest x-ray and an ECG (test to measure the electrical activity of the heart). The status of the lymphoma will be evaluated by bone marrow biopsy. 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. CT scans and gallium or PET scans will be performed. If you had lymphoma in other areas of your body additional tests may be needed as determined by your treating physician. Tests to evaluate the status of the lymphoma will be repeated before each cycle of chemotherapy. If your white count is low you may need injections of NeupogenTM (growth factor) daily till your white blood cell count is high enough to start the next round of 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 rituximab. Participants in the other group will not receive rituximab. There is an equal chance of being assigned to either group.
Treatment will start between 5-6 months after your stem cell transplant. If you are assigned to the rituximab group, you will receive a total of 4 cycles of treatment. Each cycle will be given 6 months apart. Each cycle is made up of 4 doses of rituximab given once a week for 4 weeks. If the disease returns or intolerable side effects occur while on treatment, you will be taken off the study. You may still be able to receive rituximab outside of this study if your treating physician decided that it is okay.
Treatment will be given on an outpatient basis. The treatment can be given at M. D. Anderson or by your local cancer doctor. Patients who are assigned to the rituximab arm must be willing to get their first and third cycle (all 4 doses) at M. D. Anderson, if their local physician is unable to draw and ship samples to the central laboratory for rituximab levels. Blood will be drawn (approximately one teaspoon) before and after the first and fourth dose and before the second and third dose of those two treatment cycles. The treatment will be given by vein over a period of several hours. Participants who have easily accessible veins may get this treatment by having a temporary needle placed in the vein for the treatment. For participants who do not have easily accessible veins, a central venous catheter (long plastic tube - CVL) will be placed in a big vein of the arm or chest.
Participants who do not receive rituximab will be followed every 6 months at M. D. Anderson as is standard of care.
All participants (even those who do not receive the rituximab) will have to return to M. D. Anderson every 6 months for a period of 3 years (from the date of enrollment) to have the lymphoma evaluated. The status of the lymphoma will be evaluated by blood tests (1-2 tablespoons), CT scans, PET or Gallium scans and bone marrow biopsy.
This is an investigational study. Rituximab has been approved by the FDA. About 90 patients will take part in the study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab |
| No Rituximbab | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present.
- Absolute neutrophil count (ANC) > 1500/mm3 independent of growth factor support
- No evidence of symptomatic cardiac or pulmonary disease
- Platelet count > 75,000 mm3
- Zubrod performance status of 2 or less.
Key exclusion criteria (3 listed)
- Uncontrolled active infection
- Severe concomitant medical or psychiatric illness
- Serum bilirubin > 2.0 mg/dl 4) Transaminases > 2xULN 5) Serum creatinine > 2.0 mg/dl
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 |
|---|---|---|
| RituximabAlso: Rituxan375 mg/m^2 by vein (IV) in 4 weekly doses (1 cycle) every 6 months for 4 cycles. | Drug | Rituximab |
Primary outcome
Number of Patients with Progression Free Survival (PFS)
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: Closed early due to slow patient accrual and sponsor's withdrawal of support.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- 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 study chair
UT MD 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 3 study testing Rituximab in people with Non-Hodgkin's 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 6 inclusion and 3 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 30 Jul 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Closed early due to slow patient accrual and sponsor's withdrawal of support.). 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?
Number of Patients with Progression Free Survival (PFS) (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 30 Jul 2012.