Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02996474|
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : April 9, 2019
Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not treated. Treatment for AML that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help.
To test if pembrolizumab, in combination with decitabine, is a possible treatment for people with relapsed or refractory AML.
Adults 18 years of age and older with refractory AML or relapsed AML.
Participants will be first screened for eligibility.
The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles. Participants may be in the study for up to 2 years if they are responding to the treatment.
The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an outpatient.
Participants will get pembrolizumab at the beginning of each cycle through an IV.
Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other cycle.
Participants will give blood samples.
Participants will have bone marrow exams. A needle will be inserted into the hip to extract cells from the bone marrow.
Some participants may give a sample of saliva from the inside of their cheek.
Some participants may give a small skin sample. The top layer of the skin is removed.
Some patients may require leukapheresis before starting treatment. This is a procedure to remove leukemia cells in the blood stream.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Acute Myeloid Leukemia||Drug: Pembrolizumab Drug: Decitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia|
|Study Start Date :||December 16, 2016|
|Actual Primary Completion Date :||April 2, 2019|
|Actual Study Completion Date :||April 2, 2019|
Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days.Decitabine will ordinarily be given on days 8 through 12 and 15 through 19 on alternative cycles (ie: cycles 1, 3, 5 and 7).
200 mg will be administered as a 30 minute IV infusion every 3 weeks. Every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Will be administered at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7). Decitabine should be repeated every 6 weeks.
- Feasibility [ Time Frame: 8 cycles ]The primary aim is to assess the feasibility of this novel pembrolizumab and decitabine combination in this patient population.
- Efficacy [ Time Frame: 8 cycles plus 30 days after last dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996474
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christopher S Hourigan, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|