RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia

Summary

The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL.

The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.

Conditions

• Leukemia
• Acute 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.

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Marina Konopleva, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations