Acute Myeloid LeukemiaPhase 1/2NCT03374332
Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing Gemtuzumab Ozogamicin (GO) and Donor Leukocytes in people with Acute Myeloid Leukemia, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Gemtuzumab Ozogamicin (GO) and Donor Leukocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2019to 31 Mar 2025
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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 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 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 donor.
- 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:
- 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.
- 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 physician
- Failure to receive full informed consent.
- 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
- History of transplantation. 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 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:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Gemtuzumab Ozogamicin (GO), Donor Leukocytes
- Keywords
- Refractory, progression, recurrence
- Medical subject headings
- Leukemia, Myeloid, Acute, Disease Progression, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemtuzumab Ozogamicin (GO)Drug
Also called Mylotarg
Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor LeukocytesOther
The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1 | Experimental | Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10^7 CD3+ cells and maximum of 2x10^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion. Receives: Drug: Gemtuzumab Ozogamicin (GO); Other: Donor Leukocytes |
| Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2 | Experimental | Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10^8 CD3+ cells and maximum of 2x10^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion. Receives: Drug: Gemtuzumab Ozogamicin (GO); Other: Donor Leukocytes |
| Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level (MTD determined from Phase1) | Experimental | Maximum Tolerated Dose (MTD) determined from Phase 1 portion of study
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a dose of 1x10^7 - 2x10^7 CD3+ cells OR 1x10^8 - 2x10^8 CD3+ cells/kg irrespective of the number of CD34+ cells. MTD AS DETERMINED BY PHASE 1
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion. Receives: Drug: Gemtuzumab Ozogamicin (GO); Other: Donor Leukocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Determine the RP2D or MTD of Nonengraftment Donor Leukocyte Infusions With Fractionated Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML Defined as Dose Level Without Dose Limiting Toxicities.
The MTD of non-engraftment donor leukocyte infusions administered with fractionated gemtuzumab ozogamicin in patients with relapsed/refractory AML is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs.
The recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) was evaluated by utilizing a 3+3 design to determine if 1-2x108 CD3 cells/kg can be safely administered with fractionated Gemtuzumab Ozogamicin administered on days 1,4 and 7 (total dose capped at 13.5 mg). The leukocyte infusion is administered on day 8 after completion of GO day 7.
Two DLI dose levels well be assessed:
DLI Dose Level 1: 1-2x107 CD3+ cells/kg DLI Dose Level 2: 1-2x108 CD3+ cells/kg The RP2D/MTD is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs through 35 days post DLI.
Measured: 35 days post infusion
Response Rate
Response rate of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia.
Bone Marrow Biopsy to be done in patients thought to have responded.
Complete remission or complete remission with incomplete count recovery, after one cycle of treatment. Rationale for including CRi: CRi has previously been used in gemtuzumab ozogamicin trials because of incomplete platelet recovery seen with this drug.
Measured: 4 weeks post infusion
Secondary outcomes (3)
Number of Participants Reaching 24 Months Progression Free Survival
Progression free survival of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia.
Measured: Through 2 years post end of treatment
Number of Participants Who Met the Objective for Overall Survival at 2 Years
Overall survival of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia.
Measured: Through 2 years post end of treatment
Number of Participants With Dose Limiting Toxicities as Defined by the Protocol
Number of participants with dose limiting toxicities following treatment with gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia. DLT's defined in the protocol as
- IBMTR Severity Index C \& D graft versus host disease
- Grade 3 or 4 infusion related reaction
- Any grade 3 non-hematological toxicities not directly resulting from patient's disease (with some exclusions specified in the protocol)
- Any grade 4 related or unrelated non-hematological toxicity not directly resulting from patient's disease
- Development of SOS
- Discontinuation of treatment due to an adverse event of any grade is considered a DLT unless the AE is clearly and solely related to the underlying disease.
All Grade 5 toxicities are considered DLTs unless clearly and solely related to the underlying disease.
Measured: Start of treatment through 30 days post the final infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start31 Dec 2019
- Primary completion26 Sep 2023
- Study completion31 Mar 2025
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Pfizer
- Responsible party
- Sponsor
- Investigators
- John Reagan, MD, Principal investigator, Brown University Oncology Research Group (BrUOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374332
- Sponsor's protocol ID
- BrUOG 345
- Status last verified
- Jun 2026
- First submitted
- 29 Nov 2017
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03374332
- Acronym / sponsor ID
- BrUOG 345
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Refractory, progression, recurrence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Pfizer
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 23 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1 | Experimental | Drug: Gemtuzumab Ozogamicin (GO), Other: Donor LeukocytesDay 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10^7 CD3+ cells and maximum of 2x10^7 CD3+ cells/kg irrespective of the number of CD34+ cells. Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion. |
| Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2 | Experimental | Drug: Gemtuzumab Ozogamicin (GO), Other: Donor LeukocytesDay 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10^8 CD3+ cells and maximum of 2x10^8 CD3+ cells/kg irrespective of the number of CD34+ cells. Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion. |
| Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level (MTD determined from Phase1) | Experimental | Drug: Gemtuzumab Ozogamicin (GO), Other: Donor LeukocytesMaximum Tolerated Dose (MTD) determined from Phase 1 portion of study Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a dose of 1x10^7 - 2x10^7 CD3+ cells OR 1x10^8 - 2x10^8 CD3+ cells/kg irrespective of the number of CD34+ cells. MTD AS DETERMINED BY PHASE 1 Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (41 listed)
- 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.
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 |
|---|---|---|
| Gemtuzumab Ozogamicin (GO)Also: MylotargPatients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg. | Drug | Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1, Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2, Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level (MTD determined from Phase1) |
| Donor LeukocytesThe product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells. | Other | Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1, Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2, Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level (MTD determined from Phase1) |
Primary outcome
Phase 1: Determine the RP2D or MTD of Nonengraftment Donor Leukocyte Infusions With Fractionated Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML Defined as Dose Level Without Dose Limiting Toxicities.
Time frame: 35 days post infusion
The MTD of non-engraftment donor leukocyte infusions administered with fractionated gemtuzumab ozogamicin in patients with relapsed/refractory AML is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs. The recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) was evaluated by utilizing a 3+3 design to determine if 1-2x108 CD3 cells/kg can be safely administered with fractionated Gemtuzumab Ozogamicin administered on days 1,4 and 7 (total dose capped at 13.5 mg). The leukocyte infusion is administered on day 8 after completion of GO day 7. Two DLI dose levels well be assessed: DLI Dose Level 1: 1-2x107 CD3+ cells/kg DLI Dose Level 2: 1-2x108 CD3+ cells/kg The RP2D/MTD is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs through 35 days post DLI.
Response Rate
Time frame: 4 weeks post infusion
Response rate of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia. Bone Marrow Biopsy to be done in patients thought to have responded. Complete remission or complete remission with incomplete count recovery, after one cycle of treatment. Rationale for including CRi: CRi has previously been used in gemtuzumab ozogamicin trials because of incomplete platelet recovery seen with this drug.
3 secondary outcomes
Number of Participants Reaching 24 Months Progression Free Survival
Time frame: Through 2 years post end of treatment
Number of Participants Who Met the Objective for Overall Survival at 2 Years
Time frame: Through 2 years post end of treatment
Number of Participants With Dose Limiting Toxicities as Defined by the Protocol
Time frame: Start of treatment through 30 days post the final infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Reagan, MD principal investigator
Brown University Oncology Research Group (BrUOG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemtuzumab Ozogamicin (GO) and Donor Leukocytes in people with Acute Myeloid Leukemia, run by Brown University 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 15 inclusion and 41 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: finished, as of the sponsor's last update on 23 Jul 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2026). 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?
Phase 1: Determine the RP2D or MTD of Nonengraftment Donor Leukocyte Infusions With Fractionated Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML Defined as Dose Level Without Dose Limiting Toxicities. (time frame: 35 days post infusion). The study lists 2 primary outcomes in all. 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 23 Jul 2026.