Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/17/2018 |
| Start Date: | July 28, 2015 |
| End Date: | September 2017 |
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.
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.
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Brian Shaffer, MD
Phone: 212-639-2212
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
