Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,

Key facts

Study ID

NCT01883362

Run by

Novartis Pharmaceuticals

People needed

60

Starts

2014-02-06

Expected to finish

2018-04-30

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients between 18 and 70 years of age
• Patients with ECOG Performance Status of ≤ 2
• Patients with a documented unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia).
• Patients with a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be requested for central analysis confirmation)
• Patients who undersent allogeneic HSCT in CR1 from a matched related or matched unrelated donor. All of the following criteria had to be met: HLA typing to include available 8/8 or 7/8 allele HLA matched donor (at A,B,C, DRB1) Single allelic mismatch allowed
• Patients who had received a conditioning regimen which included one of the following:
• Busulfan/Fludarabine (Bu/Flu) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Fludarabine (120-180 mg/m2) Fludarabine / Melphalan (Flu/Mel) Fludarabine (120-180 mg/m2) Melphalan (≤ 150 mg/m2) Busulfan/Cyclophosphamide (Bu/Cy) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Cyclophosphamide (120 mg/kg) Cyclophosphamide/Total Body Irradiation (Cy/TBI) Cyclophosphamide (120 mg/kg) TBI (1200-1420 cGy)
• Recovery of counts by day 42 and was able to start midostaurin by day 60 post-HSCT (first dose of midostaurin to start no earlier than 28 days post-HSCT); ANC >1000µL, platelets ≥20,000 without platelet transfusion

You may not qualify if…

• Patients eligible for this study must not have met any of the following criteria:
• Patients who failed prior attempts at allogeneic HSCT
• Patients who had received an autologous transplant
• Patients with Acute GVHD Grade III-IV
• Patients with a known confirmed diagnosis of HIV infection or active viral hepatitis.
• Impaired cardiac function including any of the following:
• Screening ECG with a QTc > 450 msec. If QTc > 450 and electrolytes were not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc.
• Patients with congenital long QT syndrome
• History or presence of sustained ventricular tachycardia
• Any history of ventricular fibrillation or torsades de pointes
• Bradycardia defined as HR. < 50 bpm
• Right bundle branch block + left anterior hemiblock (bifascicular block)
• Patients with myocardial infarction or unstable angina < 6 months prior to starting study
• Congestive Heart Failure NY Heart Association class III or IV
• Patients with an ejection fraction < 45% assessed by MUGA or ---ECHO within 28 days prior to starting study cycle 1 (of midostaurin or control group)
• Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolves to ≤ Grade 1 within screening timeframe)
• Patient required treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment
• Pregnant or nursing (lactating) women, or women of child-bearing potential, must have used highly effective methods of contraception during dosing and for 30 days after treatment completion

Where it is running

• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• University of California at Los Angeles Oncology — Los Angeles, California, United States
• SCRI- Colorado Blood Cancer Institute — Denver, Colorado, United States
• H Lee Moffitt Cancer Center and Research Institute Oncology — Tampa, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Karmanos Cancer Institute Karmanos - Wayne State — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School Of Medicine-Siteman Cancer Ctr Washington U School of Med — St Louis, Missouri, United States
• Hackensack University Medical Center Hackensack Univ Med Ctr (32) — Hackensack, New Jersey, United States
• University of North Carolina at Chapel Hill University of North Carolina 6 — Chapel Hill, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Tennessee Oncology Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Vanderbilt Univeristy Oncology — Nashville, Tennessee, United States
• Baylor Health Care System/Sammons Cancer Center Oncology — Dallas, Texas, United States
• Texas Transplant Physicians Group Oncology 2 — San Antonio, Texas, United States
• Fred Hutchinson Cancer Research Center Oncology — Seattle, Washington, United States
• Novartis Investigative Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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