LymphomaPhase 2NCT00472056
Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
A Phase 2 study testing Carmustine, Etoposide and Cytarabine in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Cohort 1: Patients who are less than or equal to 65 years of age. 1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) Cohort 2: Patients who are older than 65 years of age 1. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Carmustine, Etoposide and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority
- Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
- Age less than or equal to 80 years. There is no lower age limit for this study.
- Zubrod performance status of less than 2
- Negative pregnancy test in patients with child bearing potential
- Must be willing to sign informed consent
- Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.
Who cannot join
- Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.
- Less than 3 weeks from last cytotoxic chemotherapy
- Serum bilirubin > 1.5 mg/dl
- Serum transaminases > 2X/ULN
- Serum creatinine > 1.6 mg/dl
- Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight
Show all 9Show fewer
- Left ventricular ejection fraction of < 40%, unless cleared by cardiology
- Corrected DLCO of < 50%
- Patients who are on anticoagulants or antiplatelet agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Using Standard Dose Versus High Dose Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Diffuse Large B Cell Lymphomas
Cohort 1: Patients who are less than or equal to 65 years of age.
- To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
Cohort 2: Patients who are older than 65 years of age
- To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
- To determine the treatment related mortality (TRM)
Read the detailed description
Carmustine, cytarabine, etoposide, melphalan, and rituximab are all standard chemotherapy drugs.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive high dose rituximab with transplantation and high dose chemotherapy. Participants in the other group will receive standard dose rituximab with transplantation and high dose chemotherapy. The first 10 patients enrolled on this study will have an equal chance of being assigned to either group. After the first 10 participants are enrolled, the remaining participants will have a higher chance of being assigned to the group that has proven to be more effective.
All participants will have a plastic tube (catheter) inserted under their collarbone. This catheter will be left in place for the entire treatment period. 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.
Stem cell collection is done on a separate study and patients will take part in this study only after the stem cell collection is complete. You should have an adequate number of stem cells collected and stored before you can be eligible for high-dose chemotherapy and transplantation.
All treatment will be given at M. D. Anderson. You will be admitted to the hospital to receive high dose chemotherapy and will stay in the hospital for 3-4 weeks. You will be given carmustine by vein over 1 hour on Day 1. On Days 2 - 5, you will be given cytarabine by vein over 1 hour and etoposide by vein over 3 hours. This will be repeated every 12 hours on Days 2-5. On Day 6, you will be given melphalan by vein over 30 minutes. On Day 7, the stem cells that were collected earlier will be given back to you ("transplanted") through the catheter over 30-45 minutes.
You will also receive either high dose or standard dose rituximab by vein over 4-6 hours one day after the transplant (Day 1) and then again 1 week later (Day 8).
You will receive G-CSF injections staring at Day 1 (one day after transplant or stem cell infusion). These will continue our cell count reaches the appropriate level for at least 3 days in a row. Blood tests (2 teaspoons) will be done every day while you are in the hospital to track the effects of the transplant.
You will be asked to return to M. D. Anderson at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date. At each visit you will get blood work (1-2 tablespoons), CT scans, and other tests like bone marrow (if needed) to determine the status of your lymphoma.
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
- Being tested
- Carmustine, Etoposide, Cytarabine, Melphalan, Rituximab
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoid Malignancies, Lymphoma, BEAM Chemotherapy, Carmustine, BCNU, BiCNU, Etoposide, VePesid, Cytarabine, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride, Ara-C, Melphalan, Rituximab, Rituxan
- 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.
CarmustineDrug
Also called BCNU, BiCNU
300 mg/m^2 IV for 1 Day
EtoposideDrug
Also called VePesid
Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days
CytarabineDrug
Also called Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride
Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days
MelphalanDrug
140 mg/m^2 IV x 1 Day
RituximabDrug
Also called Rituxan
Cohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.
| Study group | Role | What they receive |
|---|---|---|
| BEAM + Standard Rituximab | Experimental | Arm 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Rituximab with Standard Rituximab for Cohort 1 or 2
Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1.
Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1.
Standard Rituximab: 375 mg/m^2 IV Days +1, +8 after Stem Cell Infusion on Day 0. Receives: Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Drug: Rituximab |
| BEAM + High Rituximab | Experimental | BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1.
Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1.
High Dose Rituximab: 1000 mg/m^2 IV Days +1, +8 after Stem Cell Infusion on Day 0 Receives: Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.
Measured: Up to 5 years from transplant date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMar 2005
- Primary completionJun 2012
- Study completionJun 2012
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.
- 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472056
- Sponsor's protocol ID
- 2004-0271
- Status last verified
- Jun 2012
- First submitted
- 9 May 2007
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Using Standard Dose Versus High Dose Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Diffuse Large B Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00472056
- Acronym / sponsor ID
- 2004-0271
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoid Malignancies, Lymphoma, BEAM Chemotherapy, Carmustine, BCNU, BiCNU, Etoposide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Posted 13 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cohort 1: Patients who are less than or equal to 65 years of age.
- To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
Cohort 2: Patients who are older than 65 years of age
- To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
- To determine the treatment related mortality (TRM)
Detailed description
Carmustine, cytarabine, etoposide, melphalan, and rituximab are all standard chemotherapy drugs.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive high dose rituximab with transplantation and high dose chemotherapy. Participants in the other group will receive standard dose rituximab with transplantation and high dose chemotherapy. The first 10 patients enrolled on this study will have an equal chance of being assigned to either group. After the first 10 participants are enrolled, the remaining participants will have a higher chance of being assigned to the group that has proven to be more effective.
All participants will have a plastic tube (catheter) inserted under their collarbone. This catheter will be left in place for the entire treatment period. 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.
Stem cell collection is done on a separate study and patients will take part in this study only after the stem cell collection is complete. You should have an adequate number of stem cells collected and stored before you can be eligible for high-dose chemotherapy and transplantation.
All treatment will be given at M. D. Anderson. You will be admitted to the hospital to receive high dose chemotherapy and will stay in the hospital for 3-4 weeks. You will be given carmustine by vein over 1 hour on Day 1. On Days 2 - 5, you will be given cytarabine by vein over 1 hour and etoposide by vein over 3 hours. This will be repeated every 12 hours on Days 2-5. On Day 6, you will be given melphalan by vein over 30 minutes. On Day 7, the stem cells that were collected earlier will be given back to you ("transplanted") through the catheter over 30-45 minutes.
You will also receive either high dose or standard dose rituximab by vein over 4-6 hours one day after the transplant (Day 1) and then again 1 week later (Day 8).
You will receive G-CSF injections staring at Day 1 (one day after transplant or stem cell infusion). These will continue our cell count reaches the appropriate level for at least 3 days in a row. Blood tests (2 teaspoons) will be done every day while you are in the hospital to track the effects of the transplant.
You will be asked to return to M. D. Anderson at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date. At each visit you will get blood work (1-2 tablespoons), CT scans, and other tests like bone marrow (if needed) to determine the status of your lymphoma.
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 |
|---|---|---|
| BEAM + Standard Rituximab | Experimental | Drug: Carmustine, Drug: Etoposide, Drug: Cytarabine, Drug: Melphalan, Drug: RituximabArm 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Rituximab with Standard Rituximab for Cohort 1 or 2 Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Standard Rituximab: 375 mg/m^2 IV Days +1, +8 after Stem Cell Infusion on Day 0. |
| BEAM + High Rituximab | Experimental | Drug: Carmustine, Drug: Etoposide, Drug: Cytarabine, Drug: Melphalan, Drug: RituximabBEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. High Dose Rituximab: 1000 mg/m^2 IV Days +1, +8 after Stem Cell Infusion on Day 0 |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority
- Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
- Age less than or equal to 80 years. There is no lower age limit for this study.
- Zubrod performance status of less than 2
- Negative pregnancy test in patients with child bearing potential
Key exclusion criteria (9 listed)
- Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.
- Less than 3 weeks from last cytotoxic chemotherapy
- Serum bilirubin > 1.5 mg/dl
- Serum transaminases > 2X/ULN
- Serum creatinine > 1.6 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 |
|---|---|---|
| CarmustineAlso: BCNU, BiCNU300 mg/m^2 IV for 1 Day | Drug | BEAM + High Rituximab, BEAM + Standard Rituximab |
| EtoposideAlso: VePesidArm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days | Drug | BEAM + High Rituximab, BEAM + Standard Rituximab |
| CytarabineAlso: Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochlorideArm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days | Drug | BEAM + High Rituximab, BEAM + Standard Rituximab |
| Melphalan140 mg/m^2 IV x 1 Day | Drug | BEAM + High Rituximab, BEAM + Standard Rituximab |
| RituximabAlso: RituxanCohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion. | Drug | BEAM + High Rituximab, BEAM + Standard Rituximab |
Primary outcome
Disease-free Survival (DFS)
Time frame: Up to 5 years from transplant date.
DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink 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
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 2 study testing Carmustine, Etoposide and Cytarabine 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 7 inclusion and 9 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 15 Mar 2016. 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 13 Feb 2012). 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?
Disease-free Survival (DFS) (time frame: Up to 5 years from transplant date.). 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 15 Mar 2016.