Nivolumab in Acute Myeloid Leukemia (AML) in Remission at High Risk for Relapse

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Both

Summary

The goal of this clinical research study is to learn if opdivo (nivolumab) can help to control Acute Myeloid Leukemia (AML). The safety of nivolumab will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab
• Last Updated: 2016-08-11

Criteria

Inclusion Criteria:

1. Patients with AML in remission (defined as CR, CR with incomplete platelet recovery -CRp-, CR with incomplete hematologic recovery -CRi-, or partial remission defined as a bone marrow with <10% blasts after therapy with or without hematologic recovery).

2. High risk for relapse defined as: 1st CR with high risk features for relapse (including history of prior malignancy treated with chemotherapy or radiotherapy, or history of myelodysplastic syndrome, myeloproliferative disorder, chronic myelomonocytic leukemia, MDS/MPN or other hematologic malignancy thought to have evolved to AML [i.e., secondary AML, sAML]; high risk cytogenetics at diagnosis; FLT3 mutated at diagnosis; or presence or minimal residual disease assessed by PCR, cytogenetics, and/or flow cytometry at time of enrollment) 2nd CR regardless of disease characteristics at the time of diagnosis.

3. Have received induction chemotherapy and at least one cycle of consolidation chemotherapy. Patients should have achieved a CR within 12 months of enrollment onto protocol.

4. No further chemotherapy or SCT planned at the time of enrollment.

5. Age 18 years or older.

6. Adequate organ function: creatinineand ALT

7. ECOG performance status

8. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (b-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 23 weeks after the last dose of the study drug. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

9. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drug

10. Patients or their legally authorized representative must provide written informed consent.

Exclusion Criteria:

1. History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).

2. Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs.

3. Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.

4. Patients unwilling or unable to comply with the protocol.

5. Patients who are on steroids (> 10 mg/day or equivalent) or immune suppression medications.

6. Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]).

7. Patients with a history of Inflammatory Bowel Disease such as Crohn's disease and ulcerative colitis.

8. Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months), or with known HIV infection.

9. Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.

10. Females who are pregnant or lactating

11. Patients with history of previous immunomodulatory therapy.(not including lenalidomide or thalidomide).