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

STATUS

Recruiting
End date

Mar 15, 2024
participants needed

18
sponsor

Brown University

Send

Updated on 15 May 2022

See if I qualify

cancer

remission

fludarabine

hla-a

acute leukemia

refractory acute myeloid leukemia (aml)

gemtuzumab

leukapheresis

Summary

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.

Details

Condition	Acute Myeloid Leukemia
Treatment	Gemtuzumab ozogamicin (GO), Donor Leukocytes
Clinical Study Identifier	NCT03374332
Sponsor	Brown University
Last Modified on	15 May 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		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
	donor
	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
	Chagas
	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
	physician
	Inadequate renal and/or hepatic function per medical history. To be documented by
	physician
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

refractory acute myeloid leukemia (aml)

gemtuzumab

leukapheresis

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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