RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
LeukemiaAcute Lymphocytic Leukemia
Interventions
DRUG

Everolimus (RAD001)

Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy.

DRUG

Cyclophosphamide

300 mg/m\^2 intravenous (IV) over 3 hours every 12 hours x 6 doses on Days 1, 2, 3 (total dose 1800 mg/m2).

DRUG

Vincristine

2 mg IV on Day 4 and Day 11 ± 2 days.

DRUG

Doxorubicin

50 mg/m\^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given.

DRUG

Dexamethasone

40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days.

DRUG

Mesna

600 mg/m\^2 IV continuous infusion daily for 24 hours days 1-3.

DRUG

Methotrexate

200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 IV over 22 hours day 1.

DRUG

Ara-C (Cytarabine)

3 gm/m\^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.

DRUG

Methylprednisone

50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3.

DRUG

G-CSF

10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER