Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

  • End date
    Mar 15, 2024
  • participants needed
  • sponsor
    Brown University
Updated on 15 May 2022
acute leukemia
refractory acute myeloid leukemia (aml)


This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an infusion of blood cells called leukocytes from a donor, can stimulate the immune system to potentially fight the leukemia. Gemtuzmab ozogamicin is a class of drugs known as an antibody drug conjugate. The drug is given on days 1,4,7. It is infused, attaches to cells with a certain marker on the surface (the majority of which would be leukemia cells). The drug is then internalized and the chemotherapy drug becomes activated. Gemtuzumab is currently FDA approved for the treatment of acute myeloid leukemia.

The infusion of leukocytes to stimulate the immune system to fight your leukemia is investigational and has not been proven to cure cancer. This combination of Gemtuzumab Ozogamicin and donor leukocytes is not an FDA approved treatment and is investigational.

Initially a total of 6 patients will be included in the study to assess the safety of the treatment. Once 6 patients have been treated and no unacceptable toxicities are seen, more patients will be enrolled. The study will treat up to 18 patients on the study.

Condition Acute Myeloid Leukemia
Treatment Gemtuzumab ozogamicin (GO), Donor Leukocytes
Clinical Study IdentifierNCT03374332
SponsorBrown University
Last Modified on15 May 2022


Yes No Not Sure

Inclusion Criteria

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 years
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 document status
Performance status ≤ 2 (or KPS 70)

Exclusion Criteria

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
Typing is required at the following loci: HLA A, B, C, and DRB1
infusions it is preferable, therefore agreement is important at screening). This must
be documented in writing by treating physician
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 or second degree relative
If the patient/recipient is CMV negative, only CMV negative donors are eligible. If
the patient/recipient is CMV positive, CMV testing is not required for the donor
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 Exclusion Criteria
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
Active angina pectoris. To be documented by physician
exposure to infectious agents and diseases. Testing will include the following: Human
Oxygen dependent pulmonary disease. To be documented by physician
transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease
communicable disease risks associated with xenotransplantation, Chlamydia trachomatis
Failure to receive full informed consent
and for Neisseria gonorrhea, Treponema pallidum (syphilis).This will exclude the
The donor must be in good general health and not have significant cardiopulmonary
History of transplantation. To be documented by physician
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
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
atrial fibrillation
History of any lymphoid, myeloid or other non-solid malignancy. To be documented by
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
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
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
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
earlier, or
More than 2,000 mL of crystalloids within 1 hour before death or specimen
collection, whichever occurred earlier
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