Clinical Trial: Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma

Brief Summary: The goal of this clinical research study is to learn the effectiveness of intensive chemotherapy given in combination with nelarabine (followed by maintenance therapy) in the treatment of patients with T cel ALL and T cell lymphoblastic lymphoma. The safety of this treatment will also be studied.

Detailed Summary:

The intensive chemotherapy (hyper-CVAD therapy) used in this study includes a combination of 7 chemotherapy drugs. These drugs include Adriamycin (doxorubicin), cyclophosphamide, cytarabine (Ara-C), dexamethasone, methotrexate, nelarabine, and vincristine.

The maintenance therapy used in this study includes a combination of 5 chemotherapy drugs. These drugs include pegaspargase, methotrexate, prednisone, 6-mercaptopurine, and vincristine.

Ara-C is designed to insert itself into DNA (the genetic material of cells) and stop the DNA from repairing itself.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Dexamethasone, doxorubicin, methotrexate, prednisone, and 6-mercaptopurine are each designed to stop or slow the growth of cancer cells, which may cause the cells to die.

Nelarabine is designed to inhibit ("turn off") the growth and division of cancer cells.

Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

If you are found to be eligible to take part in this study, you will receive 2 kinds of intensive chemotherapy regimens (hyper-CVAD therapy and methotrexate plus Ara-C) that will alternate for a total of 8 courses (4 courses each). One (1) course of therapy is between 21 and 28 days. All chemotherapy will be given through a large vein by a central venous catheter. A central venous catheter is a s
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Complete Remission (CR) Rate [ Time Frame: 3 Years ]

Complete remission (CR) defined as normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and a platelet count of 100 x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR. Remission interval is dated from end of the 4-week normalization period that defines CR, and assessed by methods of Kaplan and Meier.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: July 12, 2007
Date Started: July 2007
Date Completion: July 2019
Last Updated: March 23, 2017
Last Verified: March 2017