LymphomaNCT00525876
Non-Myeloablative Allogeneic Stem Cell Transplantation
A study testing Cyclophosphamide, Fludarabine and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma. 2. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Cyclophosphamide, Fludarabine and Rituximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2010
- Phase
- Interventional
- 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 can be as old as 70 years.
- They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated B^2 microglobulin (> 3).
- Patients that have received prior conventional chemotherapy but have not achieved complete response (CR).
- Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
- Patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
- Patients must have a matched or 1 antigen mismatched sibling or unrelated donor.
Show all 9Show fewer
- Point Scale (PS) </= 2.
- Inclusion criteria for Immunomodulation Post transplantation: Patients can be as old as 70 years. Patients must have a diagnosis of MCL or CLL with one of the following characteristics: 1. Patients who develop disease progression or do not experience a CR within 3 months post-allogeneic transplantation 2. Patients with a weak chimerism (any mixed chimerism of donor T cells in patients receiving Campath by day 90, and less than 20% for patients not receiving Campath) or a drop of 20% or more with an amount of donor cells present in the blood < 50% by PCR .
- Continued from Inclusion # 8: Patients must have the same donor of the original transplant willing to donate lymphocytes. 4. PS </ 2.
Who cannot join
- Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted humanized monoclonal antibodies.
- Less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.
- Pregnancy or lactation.
- HIV or HTLV-I positivity.
- Serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor
- pulmonary function test - carbon monoxide diffusing capacity < 40%
- cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or echocardiography).
- Severe concomitant medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma
- To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma.
- To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.
Read the detailed description
MATCHED SIBLING TRANSPLANTS:
If you are found to be eligible to take part in this study, you will be admitted to the hospital to receive treatment. Two (2) chemotherapy drugs, fludarabine and cyclophosphamide, will be given each day for 3 days. The drugs will be given one at a time in a vein. Each treatment will take about 30 minutes. Fludarabine will be given first, and cyclophosphamide will be given 4 hours later. You will receive rituximab once a week for 4 weeks by vein over 4-8 hours. The first dose will starts one week before starting the chemotherapy.
Two days after finishing chemotherapy, you will receive a transplant of stem cells from a sibling. The stem cells will be infused into your vein. Seven days later, you will begin to receive a drug called granulocyte colony-stimulating factor (G-CSF). G-CSF helps the new stem cells do their normal work in the body;making new blood cells. You will receive G-CSF each day until your blood cell counts begin to recover to a certain level.
Sometimes the donor cells cause inflammation of the skin, liver and gut, and a reaction called graft-versus-host disease occurs. The drugs tacrolimus and methotrexate will be given to help decrease the risk of this. These drugs are also given through a vein before and after transplant . Tacrolimus will be infused two days before transplant and will continue to be given daily as a continuous infusion. Methotrexate will be given through the vein as a short infusion on Days 1, 3, and 6 after the transplant. Tacrolimus also comes in pill form, and you may switch to the pills when ready.
During your hospitalization, you will be examined daily, and blood (about 1 tablespoon) samples will be taken daily to evaluate your blood count levels, the function of your liver and kidneys, as well as electrolytes. This blood will also be used to measure tacrolimus levels and to look for any infections. You might be given blood transfusions if blood cell counts remain low.
MATCHED UNRELATED OR MISMATCHED SIBLING TRANSPLANTS:
Alemtuzumab is a drug that is designed to specifically attack some types of leukemia and lymphoma cells. In addition, it weakens the immune system, helping to prevent the rejection of donor marrow or stem cells.
TBI is designed to damage the DNA (the genetic material of cells) of cancer cells, which may kill the cancer cells.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
If you are found to be eligible to take part in this study, you will be admitted to the hospital for treatment. Alemtuzumab will be injected into your vein over a period of 4 hours. This will be done 3 days in a row (Days 1 to 3). Drugs diphenhydramine (Benadryl), solumedrol and acetaminophen (Tylenol) will be given in to decrease the risk of or ease side effects before each dose of the alemtuzumab.
You will also receive fludarabine and cyclophosphamide once a day for 3 days. They will be given on the same days as alemtuzumab. Both drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment on this study. Some participants, depending on their type of disease, will also receive rituximab. Rituximab will be given 8 days before the transplant and then once a week for a total of 4 doses.
After completion of chemotherapy, you will receive TBI, and later on the same day, blood stem cells from a donor will be given through the catheter. G-CSF, a growth factor that promotes the production of blood cells, will be injected under the skin once a day until your blood cell counts recover to a certain level.
Blood tests (about 2 tablespoons each) , urine tests, bone marrow aspirations, and x-rays will be done as needed to track the effects of the transplant. The blood tests will be drawn daily while in the hospital and then at least twice weekly as an outpatient for the first 100 days. The CT scans and bone marrow studies will be done at 1, 3, 6, and 12 months and then every 6 months for at least 3 years after transplant. You may also have transfusions of blood and platelets as needed.
IMMUNOMODULATION POST NONABLATIVE STEM CELL TRANSPLANTATION FOR PATIENTS WITH LYMPHOID MALIGNANCIES:
You will receive treatment as an outpatient. You will receive rituximab over 4 - 8 hours through a vein once a week for 4 weeks. You will also get a boost of cells from the same donor from whom you received the original transplant. These additional cells will be infused through the vein (over 30 - 60 minutes) between the second and the third dose of rituximab. The infusion may have to be done later if cells were not available as scheduled.
Sometimes the donor cells cause inflammation of the skin, liver and gut, and a reaction called graft-versus-host disease occurs. If this happens, the drug tacrolimus and methotrexate will be given to help control this reaction. These medications are usually given by pills on a daily basis.
A boost with a higher number of cells may be infused once a month for 3 months if there is no graft-versus-host disease and if disease remains.
During treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.
**
About 40 patients will take part in this study, and all will be enrolled at M. D. Anderson.
- Conditions
- Lymphoma
- Being tested
- Cyclophosphamide, Fludarabine, Rituximab, Alemtuzumab, Allogeneic Stem Cell Infusion
- Keywords
- Mantle Cell Lymphoma, Lymphoma, Allogeneic Stem Cell Transplant, Rituximab, Cyclophosphamide, Neosar, Cytoxan, Fludarabine, Fludara, Fludarabine phosphate, Rituxan, Alemtuzumab, CAMPATH-1H, Campath, Total Body Irradiation, TBI
- Medical subject headings
- Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, Neosar
Matched Donors:
750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine.
Unrelated or Mismatched Donors:
1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine.
(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
FludarabineDrug
Also called Fludarabine phosphate, Fludara
30 mg/m^2 given intravenously on Days -5 and -3 before transplantation.
(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
RituximabDrug
Also called Rituxan
Matched Donors:
375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
Unrelated/Mismatched Donors:
375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation.
(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
For development of disease progression or no response, immunomanipulation with Rituximab 375 mg/m^2 given intravenously, then 1000 mg/m^2 given intravenously weekly for 3 weeks, and taper off Tacrolimus dose over 2 weeks.
DLI = Donor Lymphocyte Infusion/Immunomodulation Post Transplantation Immunomodulation for patients with lymphoid Malignancies:
375 mg/m^2 then 1000 mg/m^2 weekly x 3 if immunomanipulation is undertaken for persistent disease.
AlemtuzumabDrug
Also called CAMPATH-1H, Campath
Unrelated/Mismatched Donors:
15 mg per day given intravenously days 1 through 3 after transplantation.
(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
Allogeneic Stem Cell InfusionProcedure or surgery
Also called ASCT
Infusion of stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Matched Sibling Transplant | Experimental | Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab; Procedure: Allogeneic Stem Cell Infusion |
| Allo MUD & MM | Experimental | Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab; Drug: Alemtuzumab; Procedure: Allogeneic Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)
Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.
Measured: 100 days post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startJan 2005
- Primary completionSep 2010
- Study completionSep 2010
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Issa F. Khouri, MD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525876
- Sponsor's protocol ID
- 2004-0309
- Status last verified
- Nov 2011
- First submitted
- 4 Sep 2007
- Last updated
- 7 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00525876
- Acronym / sponsor ID
- 2004-0309
- Conditions
- Lymphoma
- Keywords
- Mantle Cell Lymphoma, Lymphoma, Allogeneic Stem Cell Transplant, Rituximab, Cyclophosphamide, Neosar, Cytoxan, Fludarabine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Posted 7 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma.
- To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.
Detailed description
MATCHED SIBLING TRANSPLANTS:
If you are found to be eligible to take part in this study, you will be admitted to the hospital to receive treatment. Two (2) chemotherapy drugs, fludarabine and cyclophosphamide, will be given each day for 3 days. The drugs will be given one at a time in a vein. Each treatment will take about 30 minutes. Fludarabine will be given first, and cyclophosphamide will be given 4 hours later. You will receive rituximab once a week for 4 weeks by vein over 4-8 hours. The first dose will starts one week before starting the chemotherapy.
Two days after finishing chemotherapy, you will receive a transplant of stem cells from a sibling. The stem cells will be infused into your vein. Seven days later, you will begin to receive a drug called granulocyte colony-stimulating factor (G-CSF). G-CSF helps the new stem cells do their normal work in the body;making new blood cells. You will receive G-CSF each day until your blood cell counts begin to recover to a certain level.
Sometimes the donor cells cause inflammation of the skin, liver and gut, and a reaction called graft-versus-host disease occurs. The drugs tacrolimus and methotrexate will be given to help decrease the risk of this. These drugs are also given through a vein before and after transplant . Tacrolimus will be infused two days before transplant and will continue to be given daily as a continuous infusion. Methotrexate will be given through the vein as a short infusion on Days 1, 3, and 6 after the transplant. Tacrolimus also comes in pill form, and you may switch to the pills when ready.
During your hospitalization, you will be examined daily, and blood (about 1 tablespoon) samples will be taken daily to evaluate your blood count levels, the function of your liver and kidneys, as well as electrolytes. This blood will also be used to measure tacrolimus levels and to look for any infections. You might be given blood transfusions if blood cell counts remain low.
MATCHED UNRELATED OR MISMATCHED SIBLING TRANSPLANTS:
Alemtuzumab is a drug that is designed to specifically attack some types of leukemia and lymphoma cells. In addition, it weakens the immune system, helping to prevent the rejection of donor marrow or stem cells.
TBI is designed to damage the DNA (the genetic material of cells) of cancer cells, which may kill the cancer cells.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
If you are found to be eligible to take part in this study, you will be admitted to the hospital for treatment. Alemtuzumab will be injected into your vein over a period of 4 hours. This will be done 3 days in a row (Days 1 to 3). Drugs diphenhydramine (Benadryl), solumedrol and acetaminophen (Tylenol) will be given in to decrease the risk of or ease side effects before each dose of the alemtuzumab.
You will also receive fludarabine and cyclophosphamide once a day for 3 days. They will be given on the same days as alemtuzumab. Both drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment on this study. Some participants, depending on their type of disease, will also receive rituximab. Rituximab will be given 8 days before the transplant and then once a week for a total of 4 doses.
After completion of chemotherapy, you will receive TBI, and later on the same day, blood stem cells from a donor will be given through the catheter. G-CSF, a growth factor that promotes the production of blood cells, will be injected under the skin once a day until your blood cell counts recover to a certain level.
Blood tests (about 2 tablespoons each) , urine tests, bone marrow aspirations, and x-rays will be done as needed to track the effects of the transplant. The blood tests will be drawn daily while in the hospital and then at least twice weekly as an outpatient for the first 100 days. The CT scans and bone marrow studies will be done at 1, 3, 6, and 12 months and then every 6 months for at least 3 years after transplant. You may also have transfusions of blood and platelets as needed.
IMMUNOMODULATION POST NONABLATIVE STEM CELL TRANSPLANTATION FOR PATIENTS WITH LYMPHOID MALIGNANCIES:
You will receive treatment as an outpatient. You will receive rituximab over 4 - 8 hours through a vein once a week for 4 weeks. You will also get a boost of cells from the same donor from whom you received the original transplant. These additional cells will be infused through the vein (over 30 - 60 minutes) between the second and the third dose of rituximab. The infusion may have to be done later if cells were not available as scheduled.
Sometimes the donor cells cause inflammation of the skin, liver and gut, and a reaction called graft-versus-host disease occurs. If this happens, the drug tacrolimus and methotrexate will be given to help control this reaction. These medications are usually given by pills on a daily basis.
A boost with a higher number of cells may be infused once a month for 3 months if there is no graft-versus-host disease and if disease remains.
During treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.
**
About 40 patients will take part in this study, and all will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched Sibling Transplant | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Rituximab, Procedure: Allogeneic Stem Cell InfusionAllogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation. |
| Allo MUD & MM | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Rituximab, Drug: Alemtuzumab, Procedure: Allogeneic Stem Cell InfusionAllo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients can be as old as 70 years.
- They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated B^2 microglobulin (> 3).
- Patients that have received prior conventional chemotherapy but have not achieved complete response (CR).
- Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
- Patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
Key exclusion criteria (8 listed)
- Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted humanized monoclonal antibodies.
- Less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.
- Pregnancy or lactation.
- HIV or HTLV-I positivity.
- Serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor
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 |
|---|---|---|
| CyclophosphamideAlso: Cytoxan, NeosarMatched Donors: 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine. Unrelated or Mismatched Donors: 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0) | Drug | Allo MUD & MM, Matched Sibling Transplant |
| FludarabineAlso: Fludarabine phosphate, Fludara30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0) | Drug | Allo MUD & MM, Matched Sibling Transplant |
| RituximabAlso: RituxanMatched Donors: 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation. Unrelated/Mismatched Donors: 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0) For development of disease progression or no response, immunomanipulation with Rituximab 375 mg/m^2 given intravenously, then 1000 mg/m^2 given intravenously weekly for 3 weeks, and taper off Tacrolimus dose over 2 weeks. DLI = Donor Lymphocyte Infusion/Immunomodulation Post Transplantation Immunomodulation for patients with lymphoid Malignancies: 375 mg/m^2 then 1000 mg/m^2 weekly x 3 if immunomanipulation is undertaken for persistent disease. | Drug | Allo MUD & MM, Matched Sibling Transplant |
| AlemtuzumabAlso: CAMPATH-1H, CampathUnrelated/Mismatched Donors: 15 mg per day given intravenously days 1 through 3 after transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0) | Drug | Allo MUD & MM |
| Allogeneic Stem Cell InfusionAlso: ASCTInfusion of stem cells. | Procedure or surgery | Allo MUD & MM, Matched Sibling Transplant |
Primary outcome
Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)
Time frame: 100 days post transplant
Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Issa F. Khouri, MD, BS 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 study testing Cyclophosphamide, Fludarabine and Rituximab 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 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: finished, as of the sponsor's last update on 7 Dec 2011. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2011). 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?
Overall Survival at 100 Days Post Transplant (Number of Surviving Participants) (time frame: 100 days post transplant). 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 7 Dec 2011.