Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety of this treatment will also be studied. CD20 is a protein "marker" that is found in leukemia or lymphoma cells.

This is an investigational study. Liposomal vincristine is FDA approved for the treatment of patients with CLL who have relapsed at least 2 times. All of the other study drugs used in this study are FDA approved and commercially available. The combination of liposomal vincristine with the other study drugs is also being used in research only.

Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

• Leukemia

Interventions

DRUG

Rituximab

In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.

DRUG

Imatinib

600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).

DRUG

Cyclophosphamide

300 mg/m2 by vein over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7

DRUG

Doxorubicin

50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7

DRUG

Mesna

600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7

DRUG

VSLI

2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7

DRUG

Solu-Medrol

40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.

DRUG

Methotrexate

200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.

DRUG

Ara-C

3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.

DRUG

G-CSF

10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.

DRUG

Pegfilgrastim

6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.

DRUG

Dexamethasone

40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Elias Jabbour, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-05

Primary Completion

2020-11-11

Completion

2020-11-11

FDA Drug

Yes

Countries

• United States

Study Locations