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

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia Lymphoma

Drug Information available for: Dexamethasone Cyclophosphamide Vincristine Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Nelarabine Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

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 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Hyper-CVAD + Nelarabine 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) Other Names: Adriamycin Rubex 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). Other Names: Neosar Cytoxan 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 Other Names: Ara-C Cytosar DepoCyt Cytosine Arabinosine Hydrochloride Drug: Dexamethasone Hyper-CVAD (odd courses 1, 3, 5, 7): 40 mg IV or by mouth (PO) daily days 1-4 and 11-14. Other Name: Decadron 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. Other Name: Arranon

Arms

Assigned Interventions

Experimental: Hyper-CVAD + Nelarabine

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)

Other Names:

Adriamycin
Rubex

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).

Other Names:

Neosar
Cytoxan

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

Other Names:

Ara-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride

Drug: Dexamethasone

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

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

Other Name: Decadron

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.

Other Name: Arranon

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
UT MD 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:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00501826 History of Changes
Other Study ID Numbers:	2006-0328
Study First Received:	July 12, 2007
Last Updated:	February 1, 2012
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:

Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Dexamethasone

Doxorubicin
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012