Acute Myeloid Leukemia (AML)NCT02519712
Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors
A study testing Induction Chemotherapy and G-PBSC Infusion in people with Acute Myeloid Leukemia (AML), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test a method of bone marrow transplantation that results in only temporary donor immune function. In other words, the donor immune cells are given in a way that will allow them to attack leukemia briefly before being destroyed by their own immune system, or "rejected." The… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Induction Chemotherapy and G-PBSC Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60.
- Patients with a new diagnosis of histologically confirmed (according to WHO classification 2008) acute myeloid leukemia (either primary or secondary AML) are included.
- Patients with a diagnosis of myelodysplastic syndrome with >/= 10% bone marrow blasts with no response or progression of disease after at least 4 cycles of a hypomethylating agent (5-azacytiine or decitabine).
- Patients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after G-CSF administration.
- Karnofsky performance status > 70%.
- Hepatic function - total bilirubin < 2 and, AST < 2.5 x upper limit of normal, unless liver is involved with disease or a history of Gilbert's disease.
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- Renal function - adequate renal function as demonstrated by a serum creatinine <2 mg/dl.
- LVEF ≥ 50% as determined by echocardiogram or MUGA.
- Ability to give informed consent.
- Donor Eligibility:
- Donor is blood-related and HLA-haploidentical to the recipient.
- Donor ≥18 years old
- Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, and West Nile Virus . Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus.
- Donor has a CXR and EKG performed.
- Donor is not allergic to G-CSF.
- Donor must be able to undergo leukapheresis
- Donor is not pregnant.
- Donor does not have concurrent malignancy or autoimmune disease.
- Ability to give informed consent.
Who cannot join
- Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 20080
- Major surgery or irradiation within two weeks.
- Previous therapy with cytotoxic agents for AML. Persons with previous treatments for myelodysplasia/myeloproliferation such as hydroxyurea, interferon, hypomethylating agents (5-azacitidine or decitabine), lenalidomide, or JAK/STAT inhibitors may participate but must have >1 week off therapy prior to enrollment.
- Active CNS disease.
- Uncontrolled infection.
- Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the therapy.
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- Male and female patients of child-bearing potential unwilling to use effective means of contraception.
- HIV or HTLV I/II seropositivity.
- Concurrent active malignancy other than AML requiring therapy.
- Clinically significant cardiac disease (NY Heart Association Class III or IV) or pulmonary disease.
- Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
- Donor Exclusion:
- Donor has cardiac risk factors precluding ability to undergo leukapheresis.
- Donor has evidence of concurrent malignancy or autoimmune disease.
- Donor is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to test a method of bone marrow transplantation that results in only temporary donor immune function. In other words, the donor immune cells are given in a way that will allow them to attack leukemia briefly before being destroyed by their own immune system, or "rejected." The investigators want to test whether temporary donor immune function is enough to improve the odds of achieving a remission without exposing the patient to the toxicities of a full bone marrow transplant. To do this, the investigators will use standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be a family member who is haploidentically, or half matched, to the patient such as a child or sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from rejecting the donor stem cells. The investigators will then follow the patient to see how long the donor stem cells stay in them. The study will test whether this process is feasible and can result in improved chances of obtaining a remission.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Induction Chemotherapy, G-PBSC Infusion
- Keywords
- Induction Chemotherapy, G-CSF-Mobilized Stem Cells, Haploidentical Related Donors, 15-141
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction ChemotherapyDrug
Patients with newly diagnosed AML will receive standard induction chemotherapy with daunorubicin and cytarabine (7+3 scheme). Patients who achieve CR may undergo consolidation chemotherapy at the discretion of the treating leukemia physician.
G-PBSC InfusionProcedure or surgery
G-CSF-mobilized peripheral blood cells will be collected from the donors in the Donor Room according to standard MSKCC BMT guidelines. Patients will be infused by infusion of unmanipulated G-PBSC from a haploidentical related donor.
| Study group | Role | What they receive |
|---|---|---|
| Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells | Experimental | This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. Receives: Drug: Induction Chemotherapy; Procedure: G-PBSC Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR)
Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected.
Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain < 5% blasts. Auer rods should not be detected.
Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study start28 Jul 2015
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Lack of 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 Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Shaffer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519712
- Sponsor's protocol ID
- 15-141
- Status last verified
- Sep 2017
- First submitted
- 6 Aug 2015
- Last updated
- 6 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors
- ClinicalTrials.gov ID
- NCT02519712
- Acronym / sponsor ID
- 15-141
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Induction Chemotherapy, G-CSF-Mobilized Stem Cells, Haploidentical Related Donors, 15-141
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Posted 6 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a method of bone marrow transplantation that results in only temporary donor immune function. In other words, the donor immune cells are given in a way that will allow them to attack leukemia briefly before being destroyed by their own immune system, or "rejected." The investigators want to test whether temporary donor immune function is enough to improve the odds of achieving a remission without exposing the patient to the toxicities of a full bone marrow transplant. To do this, the investigators will use standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be a family member who is haploidentically, or half matched, to the patient such as a child or sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from rejecting the donor stem cells. The investigators will then follow the patient to see how long the donor stem cells stay in them. The study will test whether this process is feasible and can result in improved chances of obtaining a remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells | Experimental | Drug: Induction Chemotherapy, Procedure: G-PBSC InfusionThis is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 60.
- Patients with a new diagnosis of histologically confirmed (according to WHO classification 2008) acute myeloid leukemia (either primary or secondary AML) are included.
- Patients with a diagnosis of myelodysplastic syndrome with >/= 10% bone marrow blasts with no response or progression of disease after at least 4 cycles of a hypomethylating agent (5-azacytiine or decitabine).
- Patients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after G-CSF administration.
- Karnofsky performance status > 70%.
Key exclusion criteria (15 listed)
- Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 20080
- Major surgery or irradiation within two weeks.
- Previous therapy with cytotoxic agents for AML. Persons with previous treatments for myelodysplasia/myeloproliferation such as hydroxyurea, interferon, hypomethylating agents (5-azacitidine or decitabine), lenalidomide, or JAK/STAT inhibitors may participate but must have >1 week off therapy prior to enrollment.
- Active CNS disease.
- Uncontrolled infection.
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 |
|---|---|---|
| Induction ChemotherapyPatients with newly diagnosed AML will receive standard induction chemotherapy with daunorubicin and cytarabine (7+3 scheme). Patients who achieve CR may undergo consolidation chemotherapy at the discretion of the treating leukemia physician. | Drug | Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells |
| G-PBSC InfusionG-CSF-mobilized peripheral blood cells will be collected from the donors in the Donor Room according to standard MSKCC BMT guidelines. Patients will be infused by infusion of unmanipulated G-PBSC from a haploidentical related donor. | Procedure or surgery | Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells |
Primary outcome
Complete Remission (CR)
Time frame: 4 weeks
Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected. Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain < 5% blasts. Auer rods should not be detected. Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering 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.
Brian Shaffer, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction Chemotherapy and G-PBSC Infusion in people with Acute Myeloid Leukemia (AML), run by Memorial Sloan Kettering 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 19 inclusion and 15 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2018). 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?
Complete Remission (CR) (time frame: 4 weeks). 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 6 Apr 2018.