LeukemiaPhase 2NCT01518153
Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)
A Phase 2 study testing Fludarabine, Melphalan and Alemtuzumab in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Fludarabine, Melphalan and Alemtuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years and </= 65 years with one of the following: a. Acute leukemia past first remission, in first or subsequent relapse, in second or greater remission. Patients in first remission should have intermediate or high cytogenetic risk factors or flt3 mutation. Patients with primary induction failure or relapse are eligible if they have <10% bone marrow blasts, and no circulating blasts. b. Myelodysplastic syndrome with intermediate or high risk IPSS score, or treatment related MDS. c. CML resistant to tyrosine kinase inhibitor treatment in a first or subsequent chronic phase, or in accelerated phase. d. CLL, Lymphoma or Hodgkin's disease which has failed to achieve remission or recurred following initial chemotherapy. Patients must have at least a PR to salvage therapy, or low bulk untreated relapse (<2 cm largest mass). e. Multiple myeloma which has relapsed or progressed and has achieved a partial response to salvage chemotherapy.
- Patients must have one of the following donor types identified and willing to donate: a. Related donor, HLA-matched for HLA-A, -B, C and DR matched or, b. Matched Unrelated Donor (MUD), HLA-matched for HLA A, B, C and DRB1 using allele level typing.
- Performance score of at least 80% by Karnofsky or performance score 0 to 2 (ECOG).
- Estimated creatinine clearance >40 ml/min (based on serum creatinine)
- Bilirubin <1.5 mg/dl except for Gilbert's disease.
- ALT < 300 IU/ml d.
Show all 9Show fewer
- Left ventricular ejection fraction equal or greater than 40%.
- Pulmonary function test (PFT) demonstrating a diffusion capacity (corrected for hemoglobin) of least 50% predicted.
- Patient or patient's legal representative able to sign informed consent.
Who cannot join
- Patients who have had prior autologous transplants or prior allogeneic transplants are not eligible.
- Uncontrolled active infection.
- Positive Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Women of child bearing potential not willing to use an effective contraceptive measure while on study.
- Subject has known sensitivity to any of the products that will be administered during the study.
- Patients who are HIV seropositive.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation
The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body.
Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:
Read more
- Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
- Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.
- Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD).
The donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.
Read the detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups involving the dose of T-cells in the donor lymphocyte infusion.
- Group 1 will receive a low dose of donor T-cells.
- Group 2 will receive a higher dose of donor T-cells than Group 1.
Both you and your study doctor will know which group you are in. Both groups will have a stem cell transplant. The stem cells will be given by vein. The cells will travel to your bone marrow where they are designed to make healthy, new blood cells after several weeks.
Study Drug Administration:
Patients receive fludarabine, melphalan and alemtuzumab to kill malignant cells and suppress immunity to prevent rejection of the stem cell transplant. The day you receive the stem cells is called Day 0. The days before you receive your stem cells are called minus days. The days after you receive the stem cells are called plus days.
On Day -7, you will be admitted to the hospital and given fluids by vein to hydrate you.
On Days -6 through -3, you will receive fludarabine by vein over 1 hour each day.
On Day -2, you will receive melphalan by vein over 30 minutes.
On Day -1, you will receive alemtuzumab by vein over 2 hours.
On Day 0, you will receive the stem cell transplant as a cell infusion by vein.
After the transplant, you will receive tacrolimus and methotrexate. At first, you will receive tacrolimus as a continuous (nonstop) infusion until you are able to take it by mouth. You will then take tacrolimus by mouth 2 times a day for about 5 weeks and then your doctor will tell you how to taper it off (gradually stop taking it). On Days 1, 3, and 6 after the transplant, you will receive methotrexate by vein over 30 minutes.
You will receive filgrastim as an injection under the skin 1 time a day, starting 1 week after the transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.
Between Day +56 and +64, if you are in stable medical condition and have not developed GvHD, you will receive a donor lymphocyte infusion containing T-cells by vein over 10-30 minutes. You will receive Benadryl (diphenhydramine) by vein over 15 minutes before the infusion to lower the risk of an allergic reaction.
Study Visits:
Before the T-cell infusion:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn to see how well the transplant has "taken".
- You will have a bone marrow aspiration and biopsy to check the status of the disease, if your doctor thinks it is needed. To collect a bone marrow aspiration/biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
After the T-cell infusion, you will have a physical exam every week for at least 6 weeks.
About 3, 6, and 12 months after the transplant:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check the level of the infused T-cells, for immune function tests, and to check the status of the disease.
- You will have a bone marrow aspiration, blood tests and CT scans as medically necessary to check the status of the disease, if your doctor thinks it is needed.
During the study, you will have blood draws (about 2 teaspoons) and urine will be collected for routine tests, to check your blood counts, kidney and liver function, and/or to check for infections as often as the doctor thinks is needed during this time.
Length of Treatment:
You will be off study after your 12-month follow-up visit. You will be taken off study early if you have graft failure (the donor cells did not "take") or if the cancer comes back and needs another treatment.
This is an investigational study. Melphalan, fludarabine, and alemtuzumab are FDA approved and commercially available for the treatment of blood cancers. Donor T-cell infusions are commonly used to treat blood cancers that come back after a stem cell transplant. The investigational part of this study is to find the best dose of T-cells that are given with the goal of helping to prevent the cancer from coming back.
Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia, Lymphoma, Myeloma, Myeloproliferative Diseases
- Being tested
- Fludarabine, Melphalan, Alemtuzumab, Stem Cell Infusion, Tacrolimus
- Keywords
- Blood and Marrow Transplantation, Lymphoma, Myeloma, Myeloproliferative Diseases, Leukemia, Myelodysplastic syndrome, MDS, Hodgkin disease, Multiple myeloma, Fludarabine, Fludarabine Phosphate, Fludara, Melphalan, Alkeran, Tacrolimus, Prograf, Methotrexate, G-CSF, Filgrastim, NeupogenTM
- Medical subject headings
- Leukemia, Lymphoma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Hodgkin Disease, Multiple Myeloma, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
40 mg/m^2 by vein on Day -6 to -3.
MelphalanDrug
Also called Alkeran
140 mg/m^2 by vein on Day -2.
AlemtuzumabDrug
Also called CAMPATH-1H, Campath
50 mg by vein on Day -1.
Stem Cell InfusionProcedure or surgery
Reduced intensity stem cell transplant on Day 0.
TacrolimusDrug
Also called Prograf
0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35.
MethotrexateDrug
5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6.
G-CSFDrug
Also called Filgrastim, NeupogenTM
5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.
Low Dose Donor T-CellsProcedure or surgery
Planned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64.
High Dose Donor T-CellsProcedure or surgery
Planned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Donor T-Cells | Experimental | Fludarabine 40 mg/m^2 by vein on Day -6 to -3. Melphalan 140 mg/m^2 by vein on Day -2. Alemtuzumab 50 mg by vein on Day -1. Reduced intensity stem cell transplant on Day 0. Planned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64. Tacrolimus 0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. Methotrexate 5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. Receives: Drug: Fludarabine; Drug: Melphalan; Drug: Alemtuzumab; Procedure: Stem Cell Infusion; Drug: Tacrolimus; Drug: Methotrexate; Drug: G-CSF; Procedure: Low Dose Donor T-Cells |
| High Dose Donor T-Cells | Experimental | Fludarabine 40 mg/m^2 by vein on Day -6 to -3. Melphalan 140 mg/m^2 by vein on Day -2. Alemtuzumab 50 mg by vein on Day -1. Reduced intensity stem cell transplant on Day 0. High Dose Donor T-Cells Planned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64. Tacrolimus 0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. Methotrexate 5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. Receives: Drug: Fludarabine; Drug: Melphalan; Drug: Alemtuzumab; Procedure: Stem Cell Infusion; Drug: Tacrolimus; Drug: Methotrexate; Drug: G-CSF; Procedure: High Dose Donor T-Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).
Measured: 100 days
Secondary outcomes (1)
Overall Survival (OS)
Overall Survival is defined as the interval between day of transplant and day of death.
Measured: Every 3 months until day of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Objectives not met.
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 LeukemiaStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E. Champlin, MD,BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518153
- Sponsor's protocol ID
- 2011-1104
- Other IDs
- NCI-2012-00131
- Status last verified
- Feb 2016
- First submitted
- 23 Jan 2012
- Last updated
- 17 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01518153
- Acronym / sponsor ID
- 2011-1104
- Conditions
- Leukemia, Lymphoma, Myeloma, Myeloproliferative Diseases
- Keywords
- Blood and Marrow Transplantation, Lymphoma, Myeloma, Myeloproliferative Diseases, Leukemia, Myelodysplastic syndrome, MDS, Hodgkin disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Objectives not met.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 17 Mar 2016
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 study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body.
Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:
- Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
- Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.
- Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD).
The donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.
Detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups involving the dose of T-cells in the donor lymphocyte infusion.
- Group 1 will receive a low dose of donor T-cells.
- Group 2 will receive a higher dose of donor T-cells than Group 1.
Both you and your study doctor will know which group you are in. Both groups will have a stem cell transplant. The stem cells will be given by vein. The cells will travel to your bone marrow where they are designed to make healthy, new blood cells after several weeks.
Study Drug Administration:
Patients receive fludarabine, melphalan and alemtuzumab to kill malignant cells and suppress immunity to prevent rejection of the stem cell transplant. The day you receive the stem cells is called Day 0. The days before you receive your stem cells are called minus days. The days after you receive the stem cells are called plus days.
On Day -7, you will be admitted to the hospital and given fluids by vein to hydrate you.
On Days -6 through -3, you will receive fludarabine by vein over 1 hour each day.
On Day -2, you will receive melphalan by vein over 30 minutes.
On Day -1, you will receive alemtuzumab by vein over 2 hours.
On Day 0, you will receive the stem cell transplant as a cell infusion by vein.
After the transplant, you will receive tacrolimus and methotrexate. At first, you will receive tacrolimus as a continuous (nonstop) infusion until you are able to take it by mouth. You will then take tacrolimus by mouth 2 times a day for about 5 weeks and then your doctor will tell you how to taper it off (gradually stop taking it). On Days 1, 3, and 6 after the transplant, you will receive methotrexate by vein over 30 minutes.
You will receive filgrastim as an injection under the skin 1 time a day, starting 1 week after the transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.
Between Day +56 and +64, if you are in stable medical condition and have not developed GvHD, you will receive a donor lymphocyte infusion containing T-cells by vein over 10-30 minutes. You will receive Benadryl (diphenhydramine) by vein over 15 minutes before the infusion to lower the risk of an allergic reaction.
Study Visits:
Before the T-cell infusion:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn to see how well the transplant has "taken".
- You will have a bone marrow aspiration and biopsy to check the status of the disease, if your doctor thinks it is needed. To collect a bone marrow aspiration/biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
After the T-cell infusion, you will have a physical exam every week for at least 6 weeks.
About 3, 6, and 12 months after the transplant:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check the level of the infused T-cells, for immune function tests, and to check the status of the disease.
- You will have a bone marrow aspiration, blood tests and CT scans as medically necessary to check the status of the disease, if your doctor thinks it is needed.
During the study, you will have blood draws (about 2 teaspoons) and urine will be collected for routine tests, to check your blood counts, kidney and liver function, and/or to check for infections as often as the doctor thinks is needed during this time.
Length of Treatment:
You will be off study after your 12-month follow-up visit. You will be taken off study early if you have graft failure (the donor cells did not "take") or if the cancer comes back and needs another treatment.
This is an investigational study. Melphalan, fludarabine, and alemtuzumab are FDA approved and commercially available for the treatment of blood cancers. Donor T-cell infusions are commonly used to treat blood cancers that come back after a stem cell transplant. The investigational part of this study is to find the best dose of T-cells that are given with the goal of helping to prevent the cancer from coming back.
Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Donor T-Cells | Experimental | Drug: Fludarabine, Drug: Melphalan, Drug: Alemtuzumab, Procedure: Stem Cell Infusion, Drug: Tacrolimus, Drug: Methotrexate, Drug: G-CSF, Procedure: Low Dose Donor T-CellsFludarabine 40 mg/m^2 by vein on Day -6 to -3. Melphalan 140 mg/m^2 by vein on Day -2. Alemtuzumab 50 mg by vein on Day -1. Reduced intensity stem cell transplant on Day 0. Planned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64. Tacrolimus 0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. Methotrexate 5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. |
| High Dose Donor T-Cells | Experimental | Drug: Fludarabine, Drug: Melphalan, Drug: Alemtuzumab, Procedure: Stem Cell Infusion, Drug: Tacrolimus, Drug: Methotrexate, Drug: G-CSF, Procedure: High Dose Donor T-CellsFludarabine 40 mg/m^2 by vein on Day -6 to -3. Melphalan 140 mg/m^2 by vein on Day -2. Alemtuzumab 50 mg by vein on Day -1. Reduced intensity stem cell transplant on Day 0. High Dose Donor T-Cells Planned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64. Tacrolimus 0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. Methotrexate 5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >/= 18 years and </= 65 years with one of the following: a. Acute leukemia past first remission, in first or subsequent relapse, in second or greater remission. Patients in first remission should have intermediate or high cytogenetic risk factors or flt3 mutation. Patients with primary induction failure or relapse are eligible if they have <10% bone marrow blasts, and no circulating blasts. b. Myelodysplastic syndrome with intermediate or high risk IPSS score, or treatment related MDS. c. CML resistant to tyrosine kinase inhibitor treatment in a first or subsequent chronic phase, or in accelerated phase. d. CLL, Lymphoma or Hodgkin's disease which has failed to achieve remission or recurred following initial chemotherapy. Patients must have at least a PR to salvage therapy, or low bulk untreated relapse (<2 cm largest mass). e. Multiple myeloma which has relapsed or progressed and has achieved a partial response to salvage chemotherapy.
- Patients must have one of the following donor types identified and willing to donate: a. Related donor, HLA-matched for HLA-A, -B, C and DR matched or, b. Matched Unrelated Donor (MUD), HLA-matched for HLA A, B, C and DRB1 using allele level typing.
- Performance score of at least 80% by Karnofsky or performance score 0 to 2 (ECOG).
- Estimated creatinine clearance >40 ml/min (based on serum creatinine)
- Bilirubin <1.5 mg/dl except for Gilbert's disease.
Key exclusion criteria (6 listed)
- Patients who have had prior autologous transplants or prior allogeneic transplants are not eligible.
- Uncontrolled active infection.
- Positive Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Women of child bearing potential not willing to use an effective contraceptive measure while on study.
- Subject has known sensitivity to any of the products that will be administered during the study.
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 |
|---|---|---|
| FludarabineAlso: Fludarabine Phosphate, Fludara40 mg/m^2 by vein on Day -6 to -3. | Drug | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| MelphalanAlso: Alkeran140 mg/m^2 by vein on Day -2. | Drug | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| AlemtuzumabAlso: CAMPATH-1H, Campath50 mg by vein on Day -1. | Drug | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| Stem Cell InfusionReduced intensity stem cell transplant on Day 0. | Procedure or surgery | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| TacrolimusAlso: Prograf0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. | Drug | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| Methotrexate5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. | Drug | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| G-CSFAlso: Filgrastim, NeupogenTM5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. | Drug | High Dose Donor T-Cells, Low Dose Donor T-Cells |
| Low Dose Donor T-CellsPlanned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64. | Procedure or surgery | Low Dose Donor T-Cells |
| High Dose Donor T-CellsPlanned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64. | Procedure or surgery | High Dose Donor T-Cells |
Primary outcome
Success Rate
Time frame: 100 days
Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).
1 secondary outcome
Overall Survival (OS)
Time frame: Every 3 months until day of death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Richard E. Champlin, 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 Phase 2 study testing Fludarabine, Melphalan and Alemtuzumab in people with Leukemia and 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 6 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 17 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 17 Mar 2016). 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?
Success Rate (time frame: 100 days). 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 17 Mar 2016.