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A Phase II, Randomized, Comparative Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia


Phase 2
18 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

A Phase II, Randomized, Comparative Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia


Inclusion Criteria:



- Patients must be between 18 and 60 years of age

- Patients must have an ECOG Performance Status of < 2

- Patients must have a documented Unequivocal diagnosis of AML according to WHO 2008
classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic
leukemia).

- Patients must have a documented FLT3 ITD mutation, determined by local laboratory for
eligibility (historical tissue will be requested for central analysis confirmation)

- Patients who have undergone allogeneic HSCT in CR1 from a matched related or matched
unrelated donor. All of the following criteria must also 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 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 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

Exclusion Criteria:

- Patients whom have failed prior attempts at allogeneic HSCT

- Patients who have 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 are 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 requires 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 use
highly effective methods of contraception during dosing and for 30 days after treatment
completion

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Relapse Free Survival (RFS)

Outcome Time Frame:

18 months from date of transplant

Safety Issue:

No

Principal Investigator

Jodi Virkus, Pharm D

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CPKC412AUS23

NCT ID:

NCT01883362

Start Date:

September 2013

Completion Date:

September 2017

Related Keywords:

  • Acute Myeloid Leukemia
  • acute myeloid leukemia
  • AML
  • FLT3-ITD
  • midostaurin
  • PKC412
  • allogeneic hematopoeitic stem cell tranplant
  • SCT
  • HSCT
  • CR1
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Oregon Health Sciences UniversityPortland, Oregon  
Mayo Clinic - RochesterRochester, Minnesota  55905
MD Anderson Cancer Center/University of TexasHouston, Texas  77030
Sarah Cannon Research Institute Sarah Cannon Research (SC)Nashville, Tennessee  37203
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State UniversityColumbus, Ohio  43210
Baylor College of Medicine OncologyDallas, Texas  75246
City of Hope National Medical Center OncologyDuarte, California  91010
University of California at Los Angeles OncologyLos Angeles, California  90095
Sarah Cannon Research InstituteDenver, Colorado  80218
H. Lee Moffitt Cancer Center/University of South Florida OncologyTampa, Florida  33612
John Hopkins Kimmel Cancer Center OncologyBaltimore, Maryland  21231
Wayne State University/Wertz Clinical Cancer Center KarmanosDetroit, Michigan  48201
Washington University School Of Medicine-Siteman Cancer Ctr Washington U School of MedSt. Louis, Missouri  63110
Memorial Sloan Kettering Cancer Center OncologyNew York, New York  10021
Duke Clinical Research Institute OncologyDurham, North Carolina  27710
Vanderbilt Univeristy OncologyNashville, Tennessee  37232
Texas Transplant Physicians Group Oncology 2San Antonio, Texas  78229
Fred Hutchinson Cancer Research Center OncologySeattle, Washington  98109
University of Wisconsin OncologyMadison, Wisconsin  53792