Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00501826

Purpose

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.

Condition	Intervention	Phase
Leukemia Lymphoblastic Lymphoma Leukemia, Lymphoblastic, Acute	Drug: Doxorubicin Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Methotrexate Drug: Vincristine Drug: Nelarabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Complete Remission (CR) Rate [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hyper-CVAD + Nelarabine: Experimental Intensive chemotherapy (hyper-CVAD therapy) includes combination of 7 chemotherapy drugs: Adriamycin (doxorubicin), cyclophosphamide, cytarabine (Ara-C), dexamethasone, methotrexate, nelarabine, and vincristine.	Drug: Doxorubicin Hyper-CVAD (odd courses 1, 3, 5, 7): 50 mg/m^2 IV over 24 hours on day 4 after last dose of Cyclophosphamide (CTX) Drug: Cyclophosphamide Hyper-CVAD (odd courses 1, 3, 5, 7): 300 mg/m^2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2). Drug: Cytarabine High-dose Methotrexate plus cytarabine (even courses 2, 4, 6, 8): Cytarabine 3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 Drug: Dexamethasone Hyper-CVAD (odd courses 1, 3, 5, 7): 40 mg IV or by mouth (PO) daily days 1-4 and 11-14. Drug: Methotrexate High-dose Methotrexate plus cytarabine (even courses 2, 4, 6, 8): 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours on day 1. Drug: Vincristine Hyper-CVAD (odd courses 1, 3, 5, 7): 2 mg IV days 4 and 11 (+/- 2 days) Drug: Nelarabine 650 mg/m^2 IV over 2 hours daily x 5 days every 21 to 35 days x 2 courses.

Arms

Assigned Interventions

Hyper-CVAD + Nelarabine: Experimental

Intensive chemotherapy (hyper-CVAD therapy) includes combination of 7 chemotherapy drugs: Adriamycin (doxorubicin), cyclophosphamide, cytarabine (Ara-C), dexamethasone, methotrexate, nelarabine, and vincristine.

Drug: Doxorubicin

Hyper-CVAD (odd courses 1, 3, 5, 7):

50 mg/m^2 IV over 24 hours on day 4 after last dose of Cyclophosphamide (CTX)

Drug: Cyclophosphamide

Hyper-CVAD (odd courses 1, 3, 5, 7):

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

Drug: Cytarabine

High-dose Methotrexate plus cytarabine (even courses 2, 4, 6, 8):

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

Drug: Dexamethasone

Hyper-CVAD (odd courses 1, 3, 5, 7):

40 mg IV or by mouth (PO) daily days 1-4 and 11-14.

Drug: Methotrexate

High-dose Methotrexate plus cytarabine (even courses 2, 4, 6, 8):

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

Drug: Vincristine

Hyper-CVAD (odd courses 1, 3, 5, 7):

2 mg IV days 4 and 11 (+/- 2 days)

Drug: Nelarabine

650 mg/m^2 IV over 2 hours daily x 5 days every 21 to 35 days x 2 courses.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated T cell ALL including T cell lymphoblastic lymphoma. Failure to one induction course of chemotherapy are eligible. Patients in CR after </= 2 courses are also eligible.
ECOG performance status less than or equal to 3.
Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable. SGOT or SGPT less than or equal to 4 x ULN.
Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable.

Exclusion Criteria:

1) Pregnant or nursing women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501826

Contacts

Contact: Stefan Faderl, M.D.

713-745-4613

sfaderl@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Stefan Faderl, M.D. 713-745-4613 sfaderl@mdanderson.org
Principal Investigator: Stefan Faderl, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Stefan Faderl, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Stefan Faderl, MD / Associate Professor )
Study ID Numbers:	2006-0328
Study First Received:	July 12, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00501826 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
ALL
T-cell ALL
Lymphoblastic Lymphoma
Hyper-CVAD
Doxorubicin

Cyclophosphamide
Cytarabine
Dexamethasone
Methotrexate
Vincristine
Nelarabine

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Antineoplastic Agents
Cyclophosphamide

ClinicalTrials.gov processed this record on February 08, 2010