LeukemiaPhase 2NCT01390402
Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG
A Phase 2 study testing Fludarabine, Busulfan and NK cell infusion: in people with Leukemia and Chronic Myelogenous Leukemia, 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 if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Fludarabine, Busulfan and NK cell infusion:
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who meet the following eligibility criteria are eligible for inclusion in this study. Pediatric team to assess eligibility appropriate for patient age.
- Age </= 70 years of age.
- Patients with diagnosis of CML in first chronic phase or accelerated phase with less than 15% blast in the blood and bone marrow at study entry which has failed to respond adequately to imatinib by the consensus criteria of Baccarani et al: a) no hematologic remission at 3 months, b) no cytogenetic response at 6 months, c) no major cytogenetic response at 12 months, d) no complete cytogenetic response or major molecular response at >18 months, or e) loss of a response with increasing cytogenetic or molecular evidence of disease. Or are intolerant to tyrosine kinase inhibitor therapy. Or with second or greater chronic phase (with prior transformation who respond to treatment and have <15% blasts at study entry).
- Histocompatible stem cell donor: Patients must have an HLA matched related or unrelated donor (HLA A, B, C and DR) willing to donate for allogeneic hematopoietic transplantation.
- Haploidentical NK cell donor: Patients must have a haploidentical relative with the absence of a KIR-ligand (HLA molecule).
- Performance status: Zubrod </= 2 or Lansky PS greater or equal to 70%.
Show all 11Show fewer
- Cardiac function: left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- Pulmonary function: no symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 50% of expected, corrected for hemoglobin. For pediatric patients, if unable to perform pulmonary function tests (most children < 7 years of age), pulse oximetry >/= 92% on room air by pulse oximetry.
- Renal function: Serum creatinine </= 1.8mg/dl or creatinine clearance greater or equal than 40 cc/min. Creatinine for pediatric patients </= 1.5 mg/dl or </= 2 times upper limit of normal for age (whichever is less).
- Liver function: Bilirubin </= 1.5 mg/dl (unless Gilbert's syndrome), ALT or AST </= 200 IU/ml for adults unless related to underline disease. For pediatric patients conjugated (direct) bilirubin <2x upper limit of normal, ALT or AST <5 times upper limit of normal.No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent. Assent as is age appropriate.
Who cannot join
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Pleural/pericardial effusion or ascites estimated to be >1L
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known allergy to mouse proteins
- Active hepatitis B or C infection.
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: Natural Killer (NK) Cells and Nonmyeloablative Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
The goal of this clinical research study is to learn if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.
Read the detailed description
NK cells may react against leukemia cells, particularly when they are mismatched for certain HLA tissue type proteins. In the lab, the NK cells are separated from the blood using a machine called a CLINIMACs system. This machine uses certain kinds of cells and antibody-coated magnetic beads to separate the NK cells. The drug aldesleukin (interleukin-2, IL-2) is then added to the NK cells to improve their function. The aldesleukin will be washed out of the cell sample before it is given to you.
The NK cells will be donated from a family member who has a certain genetic type in their blood called HLA that partly matches yours. The stem cells you will receive will come from a separate HLA-identical family member or an unrelated donor.
Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
Busulfan is designed to bind to DNA, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, 6 days before the NK cell infusion, you will be admitted to the hospital and will receive hydration fluids by vein.
Starting 5 days before the NK cell infusion, you will receive fludarabine by vein over 1 hour for 4 days in a row. On the last 2 days, you will receive busulfan by vein over 3 hours. The day before the NK cell infusion, you will "rest" (not receive any drugs).
Starting 3 days before the infusion, you will receive methylprednisolone by vein over 15 minutes and antithymocyte globulin (ATG) by vein over at least 4 hours for 3 days in a row. ATG is given to help reduce the risk of transplant rejection.
On the day of the NK cell infusion, you will receive the NK cells by vein. You will receive Benadryl (diphenhydramine) by vein over 15 minutes before the infusion to help lower the risk of an allergic reaction.
Starting on the day of the NK cell infusion, you will receive aldesleukin as an injection under the skin 1 time a day for 5 days. Aldesleukin is given to help the NK cells survive and multiply.
Starting 5 days after the NK cell infusion, you will receive ATG by vein 1 time a day for 3 days.
The day after the last ATG dose, you will receive the stem cell transplant by vein.
You will also receive tacrolimus and methotrexate to help lower the risk of a reaction called graft vs. host disease (GVHD). GVHD is when the donated immune cells in the transplant react against the body of the person receiving the cells. You will receive tacrolimus by vein as a continuous infusion for about 2 weeks after the stem cell transplant. After that, you will receive tacrolimus by mouth 1 time a day for at least 3 months.
On Days 1, 3, and 6 after the stem cell transplant, you will receive methotrexate by vein over 30 minutes.
You will also receive Neupogen (filgrastim, G-CSF) as an injection under the skin 1 time a day until your blood cell counts are high enough.
Study Tests:
On Day 5 after the NK cell infusion, blood (about 2 tablespoons) will be drawn to check for NK cells.
During the study, blood (about 2 tablespoons) will be drawn 1 time to check for a protein found on NK cells. This blood will be collected during a routine blood draw, if possible, to avoid an additional needle stick. If you have a central venous catheter (CVC), blood will be drawn through the CVC.
You will need to stay in the hospital for about 4 weeks and have blood draws (about 2 teaspoons) for routine tests as often as the doctor thinks is needed during this time. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for at least 100 days after the transplant.
Length of Study:
You will be taken off study early if the disease gets worse, if intolerable side effects occur, if not enough NK cells can be collected, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the follow-up phone calls.
Long-Term Follow-Up:
At 1, 3, 6, and 12 months after your transplant:
- You will have a physical exam.
- You will be asked about any side effects you may have had.
- You will be checked for possible reactions to your treatment, including GVHD and graft failure. Graft failure occurs when donor cells may not be able to grow and multiply in your body. If this happens, there will be a high risk of infections and/or bleeding. If the number of white blood cells does not get back to high enough levels within 3 weeks after the transplant, more stem cells may need to be given.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check the level of the infused NK cells, for immune function tests, and to check the status of the disease.
- If the doctor thinks it is needed, you will have a bone marrow aspiration to check the status of the disease.
One (1) time a year for 2 years after your transplant, if you are unable to return for a follow-up visit, the study staff will call you to ask how you are doing. These phone calls should take about 10 minutes.
This is an investigational study. The way the researchers process the NK cells using the CliniMACs device is investigational. The NK cell process is not FDA approved or commercially available. It is currently being used for research purposes only. Fludarabine and busulfan are FDA approved and commercially available to treat CML.
Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia, Chronic Myelogenous Leukemia
- Being tested
- Fludarabine, Busulfan, NK cell infusion:, Interleukin-2, Anti-Thymocyte Globulin
- Keywords
- Alloreactive haploidentical NK cells, Natural killer cells, Stem Cell Transplantation, Immune cells, Chronic myelogenous leukemia, CML, Human leukocyte antigen, HLA, Graft-vs-host disease, GVHD, Antithymocyte globulin, ATG, Thymoglobulin, Interleukin-2, IL-2, Aldesleukin, Proleukin, Fludarabine, Fludarabine phosphate, Fludara
- Medical subject headings
- Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 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/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10.
BusulfanDrug
Also called Busulfex, Myleran
130 mg/ m2 by vein for 2 doses on Days -11 to -10.
NK cell infusion:Procedure or surgery
Natural killer cell infusion will be administered by vein on Day -8.
Interleukin-2Drug
Also called IL-2, Aldesleukin, Proleukin
0.5 million units subcutaneously daily for 5 days on Day -8 to day -4.
Anti-Thymocyte GlobulinDrug
Also called ATG, Thymoglobulin
2.5 mg/kg by vein for 3 doses on Days -3 to -1.
Allogeneic related Stem Cell TransplantProcedure or surgery
Allogeneic related stem cell transplant by vein on day 0.
TacrolimusDrug
Also called Prograf
Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml.
MethotrexateDrug
5 mg/m2 by vein Days 1, 3 and 6 post transplant.
G-CSFDrug
Also called Filgrastim, Neupogen
5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| NK Infusion + Chemotherapy | Experimental | Fludarabine 40 mg/m2 intravenous (IV) daily for 4 days, immediately followed by Busulfan 130 mg/ m2 IV every 24 hours and NK cell infusion IV. Receives: Drug: Fludarabine; Drug: Busulfan; Procedure: NK cell infusion:; Drug: Interleukin-2; Drug: Anti-Thymocyte Globulin; Procedure: Allogeneic related Stem Cell Transplant; Drug: Tacrolimus; Drug: Methotrexate; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Molecular Complete Remission at 3 Month Post Transplant
Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.
Measured: Baseline to up to 4 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard E. Champlin, MD,BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390402
- Sponsor's protocol ID
- 2010-0099
- Other IDs
- NCI-2011-01463, P01CA049639
- Status last verified
- Jan 2016
- First submitted
- 7 Jul 2011
- Last updated
- 3 Feb 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 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Killer (NK) Cells and Nonmyeloablative Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
- ClinicalTrials.gov ID
- NCT01390402
- Acronym / sponsor ID
- 2010-0099
- Conditions
- Leukemia, Chronic Myelogenous Leukemia
- Keywords
- Alloreactive haploidentical NK cells, Natural killer cells, Stem Cell Transplantation, Immune cells, Chronic myelogenous leukemia, CML, Human leukocyte antigen, HLA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 31 Dec 2015
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 if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.
Detailed description
NK cells may react against leukemia cells, particularly when they are mismatched for certain HLA tissue type proteins. In the lab, the NK cells are separated from the blood using a machine called a CLINIMACs system. This machine uses certain kinds of cells and antibody-coated magnetic beads to separate the NK cells. The drug aldesleukin (interleukin-2, IL-2) is then added to the NK cells to improve their function. The aldesleukin will be washed out of the cell sample before it is given to you.
The NK cells will be donated from a family member who has a certain genetic type in their blood called HLA that partly matches yours. The stem cells you will receive will come from a separate HLA-identical family member or an unrelated donor.
Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
Busulfan is designed to bind to DNA, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, 6 days before the NK cell infusion, you will be admitted to the hospital and will receive hydration fluids by vein.
Starting 5 days before the NK cell infusion, you will receive fludarabine by vein over 1 hour for 4 days in a row. On the last 2 days, you will receive busulfan by vein over 3 hours. The day before the NK cell infusion, you will "rest" (not receive any drugs).
Starting 3 days before the infusion, you will receive methylprednisolone by vein over 15 minutes and antithymocyte globulin (ATG) by vein over at least 4 hours for 3 days in a row. ATG is given to help reduce the risk of transplant rejection.
On the day of the NK cell infusion, you will receive the NK cells by vein. You will receive Benadryl (diphenhydramine) by vein over 15 minutes before the infusion to help lower the risk of an allergic reaction.
Starting on the day of the NK cell infusion, you will receive aldesleukin as an injection under the skin 1 time a day for 5 days. Aldesleukin is given to help the NK cells survive and multiply.
Starting 5 days after the NK cell infusion, you will receive ATG by vein 1 time a day for 3 days.
The day after the last ATG dose, you will receive the stem cell transplant by vein.
You will also receive tacrolimus and methotrexate to help lower the risk of a reaction called graft vs. host disease (GVHD). GVHD is when the donated immune cells in the transplant react against the body of the person receiving the cells. You will receive tacrolimus by vein as a continuous infusion for about 2 weeks after the stem cell transplant. After that, you will receive tacrolimus by mouth 1 time a day for at least 3 months.
On Days 1, 3, and 6 after the stem cell transplant, you will receive methotrexate by vein over 30 minutes.
You will also receive Neupogen (filgrastim, G-CSF) as an injection under the skin 1 time a day until your blood cell counts are high enough.
Study Tests:
On Day 5 after the NK cell infusion, blood (about 2 tablespoons) will be drawn to check for NK cells.
During the study, blood (about 2 tablespoons) will be drawn 1 time to check for a protein found on NK cells. This blood will be collected during a routine blood draw, if possible, to avoid an additional needle stick. If you have a central venous catheter (CVC), blood will be drawn through the CVC.
You will need to stay in the hospital for about 4 weeks and have blood draws (about 2 teaspoons) for routine tests as often as the doctor thinks is needed during this time. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for at least 100 days after the transplant.
Length of Study:
You will be taken off study early if the disease gets worse, if intolerable side effects occur, if not enough NK cells can be collected, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the follow-up phone calls.
Long-Term Follow-Up:
At 1, 3, 6, and 12 months after your transplant:
- You will have a physical exam.
- You will be asked about any side effects you may have had.
- You will be checked for possible reactions to your treatment, including GVHD and graft failure. Graft failure occurs when donor cells may not be able to grow and multiply in your body. If this happens, there will be a high risk of infections and/or bleeding. If the number of white blood cells does not get back to high enough levels within 3 weeks after the transplant, more stem cells may need to be given.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check the level of the infused NK cells, for immune function tests, and to check the status of the disease.
- If the doctor thinks it is needed, you will have a bone marrow aspiration to check the status of the disease.
One (1) time a year for 2 years after your transplant, if you are unable to return for a follow-up visit, the study staff will call you to ask how you are doing. These phone calls should take about 10 minutes.
This is an investigational study. The way the researchers process the NK cells using the CliniMACs device is investigational. The NK cell process is not FDA approved or commercially available. It is currently being used for research purposes only. Fludarabine and busulfan are FDA approved and commercially available to treat CML.
Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK Infusion + Chemotherapy | Experimental | Drug: Fludarabine, Drug: Busulfan, Procedure: NK cell infusion:, Drug: Interleukin-2, Drug: Anti-Thymocyte Globulin, Procedure: Allogeneic related Stem Cell Transplant, Drug: Tacrolimus, Drug: Methotrexate, Drug: G-CSFFludarabine 40 mg/m2 intravenous (IV) daily for 4 days, immediately followed by Busulfan 130 mg/ m2 IV every 24 hours and NK cell infusion IV. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who meet the following eligibility criteria are eligible for inclusion in this study. Pediatric team to assess eligibility appropriate for patient age.
- Age </= 70 years of age.
- Patients with diagnosis of CML in first chronic phase or accelerated phase with less than 15% blast in the blood and bone marrow at study entry which has failed to respond adequately to imatinib by the consensus criteria of Baccarani et al: a) no hematologic remission at 3 months, b) no cytogenetic response at 6 months, c) no major cytogenetic response at 12 months, d) no complete cytogenetic response or major molecular response at >18 months, or e) loss of a response with increasing cytogenetic or molecular evidence of disease. Or are intolerant to tyrosine kinase inhibitor therapy. Or with second or greater chronic phase (with prior transformation who respond to treatment and have <15% blasts at study entry).
- Histocompatible stem cell donor: Patients must have an HLA matched related or unrelated donor (HLA A, B, C and DR) willing to donate for allogeneic hematopoietic transplantation.
- Haploidentical NK cell donor: Patients must have a haploidentical relative with the absence of a KIR-ligand (HLA molecule).
Key exclusion criteria (6 listed)
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Pleural/pericardial effusion or ascites estimated to be >1L
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known allergy to mouse proteins
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/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10. | Drug | NK Infusion + Chemotherapy |
| BusulfanAlso: Busulfex, Myleran130 mg/ m2 by vein for 2 doses on Days -11 to -10. | Drug | NK Infusion + Chemotherapy |
| NK cell infusion:Natural killer cell infusion will be administered by vein on Day -8. | Procedure or surgery | NK Infusion + Chemotherapy |
| Interleukin-2Also: IL-2, Aldesleukin, Proleukin0.5 million units subcutaneously daily for 5 days on Day -8 to day -4. | Drug | NK Infusion + Chemotherapy |
| Anti-Thymocyte GlobulinAlso: ATG, Thymoglobulin2.5 mg/kg by vein for 3 doses on Days -3 to -1. | Drug | NK Infusion + Chemotherapy |
| Allogeneic related Stem Cell TransplantAllogeneic related stem cell transplant by vein on day 0. | Procedure or surgery | NK Infusion + Chemotherapy |
| TacrolimusAlso: PrografStarting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. | Drug | NK Infusion + Chemotherapy |
| Methotrexate5 mg/m2 by vein Days 1, 3 and 6 post transplant. | Drug | NK Infusion + Chemotherapy |
| G-CSFAlso: Filgrastim, Neupogen5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days. | Drug | NK Infusion + Chemotherapy |
Primary outcome
Number of Participants With Molecular Complete Remission at 3 Month Post Transplant
Time frame: Baseline to up to 4 months post-transplant
Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 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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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, Busulfan and NK cell infusion: in people with Leukemia and Chronic Myelogenous Leukemia, 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 11 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: finished, as of the sponsor's last update on 3 Feb 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 31 Dec 2015). 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?
Number of Participants With Molecular Complete Remission at 3 Month Post Transplant (time frame: Baseline to up to 4 months 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 3 Feb 2016.