LymphomaPhase 2NCT00505921
Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma
A Phase 2 study testing Campath-1H, 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 evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL). 2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL. 3. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Campath-1H, 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Nov 2009
- 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 must be less then 70 years old.
- Patients must have chemosensitive disease, having undergone at least partial remission with less then 10% marrow involvement by gross pathologic examination if autologous transplantation is considered.
- Newly diagnosed patients are eligible for autologous transplant. Patients in relapse would receive a non-myeloablative transplant if a sibling donor is available. Otherwise, patients would undergo autologous transplant if International Prognostic Index (IPI) is 0-1, or unrelated transplant if IPI is > 1.
Who cannot join
- Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram less than 40%, active central nervous system involvement, serum creatinine greater than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, Absolute neutrophil count (ANC) less than 1,000/mm3 and platelets less than 100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test- diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52
Primary Objectives:
- To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
- To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
- To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
- To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.
Read the detailed description
Campath is a drug that can specifically attack some types of T-cell lymphoma cells.
Before the study begins, you will have a physical exam, including blood (about 2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Patients will have a chest x-ray, an EKG (test to measure the electrical activity of the heart), and tests of lung function. Patients whose disease affects the stomach or intestines may have biopsies of these areas.
Treatment will be given in the hospital at M. D. Anderson. You will need to stay in the hospital for about 3 to 4 weeks.
A central venous catheter (plastic tube) will be placed into the large chest vein. The catheter will be left in place throughout treatment. In order to collect stem cells, G-CSF and GM-CSF will be injected under the skin. This will be done twice a day until the collection of stem cells is complete. You will receive Campath -1H through the catheter on Days 1, 2, 3, and 10 of chemotherapy treatment.
The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is given. The collection process is called apheresis. Blood is removed from the your body and the stem cells are frozen for storage. Stem cell collection takes about 3 hours. Between 3 and 5 sessions may be needed to collect enough stem cells. Sessions will be done once a day.
After stem cells are collected, you will receive high dose Carmustine over 1 hour on Day 1. You will receive cytarabine and etoposide twice a day on Days 2 through 5 and melphalan on Day 6.
One day after finishing the chemotherapy, the stem cells that were collected earlier will be infused back into you over about 30 minutes. G-CSF and GM-CSF will be injected until your white blood cell counts returns to normal.
Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. You will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital.
You might have to stay in the Houston area for 2 to 4 weeks after the transplant. After that, you will need to return to Houston every 3 months for the first year, then every 6 months for 5 years. Three months after the transplant, bone marrow exams and other tests will be done. If you show evidence of disease, you will receive another cycle of Campath -1H three times a week for 4-12 weeks. Patients will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma:
Campath is a drug that can specifically attack some types of T-cell lymphoma cells. In addition, it weakens the immune system, therefore 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.
Before the study begins, you will have a physical exam, including blood (about 1-2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have a chest x-ray, CT scans, an EKG (test to measure the electrical activity of the heart), and tests of lung function.
Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. Patients will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital.
Campath-1 H will be injected into your vein. This will be done 3 days in a row (Days 1 to 3). The drugs diphenhydramine (Benadryl), acetaminophen (Tylenol) and hydrocortisone will be given in to decrease the risk of or ease side effects.
You will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given starting day of Campath -1H.
All of the chemotherapy 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. 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 and GM-CSF, growth factors that promote the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood.
Tacrolimus will be infused through the vein, starting 2 days before transplant to decrease the risk of graft-versus-host disease. It will be changed to pills after you are discharged from the hospital. For the same purpose, methotrexate will also be given through the vein on Days 1, 3, 6 (and Day 11 if unrelated donor).
Treatment will be given in the hospital at UTMDACC. You will need to stay in the hospital for about 3 to 4 weeks.
You must stay in the Houston area for about 100 days after the transplant. After that, you will need to return to Houston every three months for the first year, then every 6 months for 5 years for blood tests (1-2 tablespoons), urine tests, and CT scans. Bone marrow aspirations and biopsies will also be performed. Patients will be taken off study if the intolerable side effects occur.
This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at UTMDACC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campath-1HDrug
Also called Alemtuzumab, Campath
3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.
G-CSFDrug
Also called Granulocyte colony-stimulating factor, GCSF, Filgrastim, Neupogen
10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.
GM-CSFDrug
Also called Granulocyte-Macrophage Colony Stimulating Factor, Sargramostim, Leukine
250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.
BCNUDrug
Also called Carmustine, BiCNU
300 mg/m2 IV over 1 hour on day -6
Stem Cell TransplantDrug
Also called SCT
Stem cell infusion on Day 0.
Preparative Regimen for Allogenic Stem Cell TransplantationDrug
Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.
CytarabineDrug
Also called ARA, Ara-C, Cytosar, DepoCyt
200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),
EtoposideDrug
Also called Etoposide phosphate, VePesid
200 mg/m2 IV twice on day -5 to -2 (total 8 doses)
MelphalanDrug
Also called Alkeran
140 mg/m2 IV on day -1.
CampathDrug
Also called Alemtuzumab, Campath-1H
15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation
FludarabineDrug
Also called Fludarabine monophosphate, Fludara
30 mg/m2 IV/day (days -6 to -4)
CyclophosphamideDrug
Also called Cytoxan, Neosar
750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).
Low dose total body irradiationRadiation
Also called LD-TBI
Low dose total body irradiation of 2 Gy day 0.
| Study group | Role | What they receive |
|---|---|---|
| Campath-1H | Experimental | 3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0. Receives: Drug: Campath-1H; Drug: G-CSF; Drug: GM-CSF; Drug: BCNU; Drug: Stem Cell Transplant; Drug: Preparative Regimen for Allogenic Stem Cell Transplantation; Drug: Cytarabine; Drug: Etoposide; Drug: Melphalan; Drug: Campath; Drug: Fludarabine; Drug: Cyclophosphamide; Radiation: Low dose total body irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Progression Free Survival at 2 Years
Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.
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 posted25 Jul 2007 (estimated)
- Study startMar 2003
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Slow Accrual.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Issa F. Khouri, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505921
- Sponsor's protocol ID
- ID02-645
- Status last verified
- Nov 2011
- First submitted
- 20 Jul 2007
- Last updated
- 16 Nov 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 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52
- ClinicalTrials.gov ID
- NCT00505921
- Acronym / sponsor ID
- ID02-645
- Conditions
- Lymphoma
- Keywords
- T-Cell Lymphoma, Lymphoma, Campath-1H, Allogenic Transplantation, Stem Cell Transplant, Alemtuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2003
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 7 Nov 2011
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 evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
- To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
- To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
- To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.
Detailed description
Campath is a drug that can specifically attack some types of T-cell lymphoma cells.
Before the study begins, you will have a physical exam, including blood (about 2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Patients will have a chest x-ray, an EKG (test to measure the electrical activity of the heart), and tests of lung function. Patients whose disease affects the stomach or intestines may have biopsies of these areas.
Treatment will be given in the hospital at M. D. Anderson. You will need to stay in the hospital for about 3 to 4 weeks.
A central venous catheter (plastic tube) will be placed into the large chest vein. The catheter will be left in place throughout treatment. In order to collect stem cells, G-CSF and GM-CSF will be injected under the skin. This will be done twice a day until the collection of stem cells is complete. You will receive Campath -1H through the catheter on Days 1, 2, 3, and 10 of chemotherapy treatment.
The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is given. The collection process is called apheresis. Blood is removed from the your body and the stem cells are frozen for storage. Stem cell collection takes about 3 hours. Between 3 and 5 sessions may be needed to collect enough stem cells. Sessions will be done once a day.
After stem cells are collected, you will receive high dose Carmustine over 1 hour on Day 1. You will receive cytarabine and etoposide twice a day on Days 2 through 5 and melphalan on Day 6.
One day after finishing the chemotherapy, the stem cells that were collected earlier will be infused back into you over about 30 minutes. G-CSF and GM-CSF will be injected until your white blood cell counts returns to normal.
Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. You will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital.
You might have to stay in the Houston area for 2 to 4 weeks after the transplant. After that, you will need to return to Houston every 3 months for the first year, then every 6 months for 5 years. Three months after the transplant, bone marrow exams and other tests will be done. If you show evidence of disease, you will receive another cycle of Campath -1H three times a week for 4-12 weeks. Patients will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma:
Campath is a drug that can specifically attack some types of T-cell lymphoma cells. In addition, it weakens the immune system, therefore 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.
Before the study begins, you will have a physical exam, including blood (about 1-2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have a chest x-ray, CT scans, an EKG (test to measure the electrical activity of the heart), and tests of lung function.
Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. Patients will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital.
Campath-1 H will be injected into your vein. This will be done 3 days in a row (Days 1 to 3). The drugs diphenhydramine (Benadryl), acetaminophen (Tylenol) and hydrocortisone will be given in to decrease the risk of or ease side effects.
You will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given starting day of Campath -1H.
All of the chemotherapy 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. 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 and GM-CSF, growth factors that promote the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood.
Tacrolimus will be infused through the vein, starting 2 days before transplant to decrease the risk of graft-versus-host disease. It will be changed to pills after you are discharged from the hospital. For the same purpose, methotrexate will also be given through the vein on Days 1, 3, 6 (and Day 11 if unrelated donor).
Treatment will be given in the hospital at UTMDACC. You will need to stay in the hospital for about 3 to 4 weeks.
You must stay in the Houston area for about 100 days after the transplant. After that, you will need to return to Houston every three months for the first year, then every 6 months for 5 years for blood tests (1-2 tablespoons), urine tests, and CT scans. Bone marrow aspirations and biopsies will also be performed. Patients will be taken off study if the intolerable side effects occur.
This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath-1H | Experimental | Drug: Campath-1H, Drug: G-CSF, Drug: GM-CSF, Drug: BCNU, Drug: Stem Cell Transplant, Drug: Preparative Regimen for Allogenic Stem Cell Transplantation, Drug: Cytarabine, Drug: Etoposide, Drug: Melphalan, Drug: Campath, Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Low dose total body irradiation3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0. Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.) Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be less then 70 years old.
- Patients must have chemosensitive disease, having undergone at least partial remission with less then 10% marrow involvement by gross pathologic examination if autologous transplantation is considered.
- Newly diagnosed patients are eligible for autologous transplant. Patients in relapse would receive a non-myeloablative transplant if a sibling donor is available. Otherwise, patients would undergo autologous transplant if International Prognostic Index (IPI) is 0-1, or unrelated transplant if IPI is > 1.
Key exclusion criteria (1 listed)
- Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram less than 40%, active central nervous system involvement, serum creatinine greater than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, Absolute neutrophil count (ANC) less than 1,000/mm3 and platelets less than 100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test- diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.
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 |
|---|---|---|
| Campath-1HAlso: Alemtuzumab, Campath3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment. | Drug | Campath-1H |
| G-CSFAlso: Granulocyte colony-stimulating factor, GCSF, Filgrastim, Neupogen10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization. | Drug | Campath-1H |
| GM-CSFAlso: Granulocyte-Macrophage Colony Stimulating Factor, Sargramostim, Leukine250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization. | Drug | Campath-1H |
| BCNUAlso: Carmustine, BiCNU300 mg/m2 IV over 1 hour on day -6 | Drug | Campath-1H |
| Stem Cell TransplantAlso: SCTStem cell infusion on Day 0. | Drug | Campath-1H |
| Preparative Regimen for Allogenic Stem Cell TransplantationCampath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0. | Drug | Campath-1H |
| CytarabineAlso: ARA, Ara-C, Cytosar, DepoCyt200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), | Drug | Campath-1H |
| EtoposideAlso: Etoposide phosphate, VePesid200 mg/m2 IV twice on day -5 to -2 (total 8 doses) | Drug | Campath-1H |
| MelphalanAlso: Alkeran140 mg/m2 IV on day -1. | Drug | Campath-1H |
| CampathAlso: Alemtuzumab, Campath-1H15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation | Drug | Campath-1H |
| FludarabineAlso: Fludarabine monophosphate, Fludara30 mg/m2 IV/day (days -6 to -4) | Drug | Campath-1H |
| CyclophosphamideAlso: Cytoxan, Neosar750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). | Drug | Campath-1H |
| Low dose total body irradiationAlso: LD-TBILow dose total body irradiation of 2 Gy day 0. | Radiation | Campath-1H |
Primary outcome
Participant Progression Free Survival at 2 Years
Time frame: 2 years
Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.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.
Issa F. Khouri, 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 Campath-1H, 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 3 inclusion and 1 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 16 Nov 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.
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 Nov 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?
Participant Progression Free Survival at 2 Years (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 16 Nov 2011.