Acute Myeloid Leukemia
Conditions
Keywords
Refractory, progression, recurrence
Brief 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.
Interventions
Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
OTHERDonor Leukocytes
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.
Sponsors
Rhode Island Hospital
The Miriam Hospital
Pfizer
Brown University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Post infusion for a total of 2 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Through 2 years post end of treatment | Progression free survival and overall survival of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia. |
| Dose limiting toxicities | Start of treatment through 30 days post the final infusion | Rate of dose limiting toxicities of gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia. |
Countries
United States
Outcome results
None listed