Inclusion Criteria of Recipient (patient):
- Histologic confirmation of acute myeloid leukemia (AML)
- Recurrence or progression (including refractory disease) of AML after at least 1 prior
standard treatment with progression within 6 months from last treatment.
- No curative treatment option is available
- ≥ 4-weeks since prior chemotherapy or radiation to cellular therapy infusion.
- Age equal to or greater than 18 years.
- Patients with a history of invasive second malignancy who are disease free for ≥ 2
- Patients must have an expected life expectancy of at least 2 months at the time of
initiation of treatment
- No active systemic infections allowed.
- Patients who have relapsed after standard autologous stem cell infusion are eligible
as long as they meet all inclusion criteria and no exclusion criteria. These patients
must be out more than 6 months from cell infusion to be eligible for enrollment.
- DLCO ≥ 40% with no symptomatic pulmonary disease.
- LVEF ≥ 40% by MUGA or echocardiogram.
- Creatinine <1.5x ULN or any serum creatinine level associated with a measured or
calculated creatinine clearance of >40 mL/min, AST and ALT < 2.5x ULN, Total Bilirubin
< 1.5 x ULN
- Women of childbearing potential and sexually active males must use 2 forms of
effective contraception method from time of consent through 6 months after completing
treatment (whether last treatment is infusion or drug).
- Not pregnant or nursing. Women of child bearing potential must have a negative serum
or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
within 7 days prior to beginning of treatment (drug). Post-menopausal women (surgical
menopause or lack of menses ≥12 months) do not need to have a pregnancy test, please
- Performance status ≤ 2 (or KPS 70)
Exclusion Criteria of Recipient (patient):
- Evidence of HIV infection.
- Any uncontrolled severe, concurrent illness which in the opinion of the treating
physician would make this protocol treatment unreasonably hazardous for the patient.
- Oxygen dependent obstructive pulmonary disease.
- Failure to demonstrate adequate compliance with medical therapy and follow-up
- Significant medical or psychiatric illness that would impair the ability to
participate in protocol therapy.
- Previous allogeneic stem cell transplant
- Patients who have had previous purine analog (fludarabine, pentostatin, 2-CDA)
treatment or treatment with alemtuzumab within 1 year of entering the study
- Previous history of Veno-occlusive disease/Sinusoidal Obstruction Syndrome
- Active hepatitis B or C
- Patients with known active central nervous system leukemia
- Patients with prior treatment of Gemtuzumab ozogamicin
- Patients eligible for allogeneic stem cell transplant
Donor Eligibility Criteria * donor eligibility must be documented and assessed by a
separate participating physician other than the treating physician of the recipient.
- Donors agree to up to 3 donor leukocyte collections as documented by assessing
physician (although it is not required that the same donor is used for all leukocyte
infusions it is preferable, therefore agreement is important at screening). This must
be documented in writing by treating physician.
- Typing is required at the following loci: HLA A, B, C, and DRB1.
- Patients with a HLA 0/6 to 3/6(using loci A, B, DR) donor match will be able to
participate in this protocol.
- Donors must be a first degree relative.
- CMV titer negative donors are preferred above CMV titer positive donors if the patient
is CMV positive. If the patient is CMV negative, only CMV negative donors are
- Although ABO blood type matching is not required given use of apheresis product
preference will be made to ABO compatible donors
- Donors must be ≥18 years of age to donate.
- Donor with a history of malignancy other than non-melanoma skin cancers are eligible
only if they had a history of a solid tumor malignancy more than five years prior to
lymphocyte donation, and are considered to be in longstanding complete remission as
documented by a physician. The donor must be healthy and have all testing criteria
completed and meet all criteria for stem cell donation.
- The donor will also be assessed by physician who will document behavioral risk for
exposure to infectious agents and diseases.Testing will include the following: Human
transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease,
communicable disease risks associated with xenotransplantation, Chlamydia trachomatis
and for Neisseria gonorrhea, Treponema pallidum (syphilis).This will exclude the
- The donor must be in good general health and not have significant cardiopulmonary,
renal, endocrine, or hepatic disease as documented in writing by physician.
- B-HCG urine or serum negative if donor is of childbearing potential within 7 days of
PBMC procurement. Not applicable for donors who are Post-menopausal (surgical
menopause or lack of menses ≥12 months).
- Donors must have adequate venous access so leukapheresis can be performed via standard
peripheral IV without the need for placement of a central venous catheter.
Donor Exclusion Criteria:
- HLA to which the patient has anti-HLA antibody (ies)
- Evidence of infection for HIV-1, HIV-2, syphilis, hepatitis B or C, HTLV 1 or 2, WNV,
- Uncontrolled diabetes mellitus. If donor has controlled diabetes this must be
documented by physician.
- Active or congestive heart failure syndrome from any cause per donor medical history.
Approval for participation by Cardiologist required to be sent to BrUOG.
- Full cardiac workup by a Cardiologist is required for any history of congestive heart
failure syndrome, conduction abnormalities or history of arrhythmia other than treated
- Active angina pectoris. To be documented by physician
- Oxygen dependent pulmonary disease. To be documented by physician
- History of any lymphoid, myeloid or other non-solid malignancy. To be documented by
- Failure to receive full informed consent.
- Inadequate renal and/or hepatic function per medical history. To be documented by
- Known history of cirrhosis or active liver disease per medical history. To be
documented by physician
- History of transplantation. To be documented by physician.
- Donor with a diagnosis of Zika in the past 6 months, or who lived in or traveled to an
area with increased risk for Zika in the past 6 months, or who had sex in the past 6
months with a person who has the risks of either having been diagnosed or lived in or
traveled to areas with increased risk.
- A donor in whom plasma dilution sufficient to affect the results of communicable
disease testing is suspected, unless: (A) You test a specimen taken from the donor
before transfusion or infusion and up to 7 days before recovery of cells or tissue; or
(B) You use an appropriate algorithm designed to evaluate volumes administered in the
48 hours before specimen collection, and the algorithm shows that plasma dilution
sufficient to affect the results of communicable disease testing has not occurred.
- Clinical situations in which you must suspect plasma dilution sufficient to affect the
results of communicable disease testing will exclude the donor. Such situations
include, but are not limited to the following:(A) Blood loss is known or suspected in
a donor over 12 years of age, and the donor has received a transfusion or infusion of
any of the following, alone or in combination:
1. More than 2,000 milliliters (mL) of blood (e.g., whole blood, red blood cells) or
colloids within 48 hours before death or specimen collection, whichever occurred
2. More than 2,000 mL of crystalloids within 1 hour before death or specimen
collection, whichever occurred earlier.