Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, January 2010

First Received: April 30, 2008 Last Updated: January 4, 2010 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00671658

Purpose

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 1/2 years can improve or cure acute lymphoblastic leukemia or lymphoblastic lymphoma.

Condition	Intervention	Phase
Leukemia Acute Lymphoblastic Leukemia	Drug: Rituximab Drug: Cyclophosphamide (CTX) Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Methotrexate (MTX) Drug: Cytarabine Drug: G-CSF	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 The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia

Resource links provided by NLM:

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

Primary Outcome Measures:

Overall Response Rate, Remission Duration or Time to Progression [ Time Frame: September 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	November 2002
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HYPER-CVAD: Experimental	Drug: Rituximab 375 mg/m2 IV Drug: Cyclophosphamide (CTX) 300 mg/m2 IV Drug: Doxorubicin 50 mg/m2 IV Drug: Vincristine 2 mg IV Drug: Dexamethasone 40 mg IV or by mouth (P.O.) Drug: Methotrexate (MTX) 200 mg/m2 IV Drug: Cytarabine 100 mg intrathecal Drug: G-CSF 10 ug/kg subcutaneous injection

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed, previously untreated ALL or lymphoblastic lymphoma, or having achieved CR with one course of induction chemotherapy.
Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.
All ages are eligible.
Zubrod performance less than or equal to 3
Adequate liver function (bilirubin </= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor).
Adequate cardiac function as assessed by history and physical examination.
No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.

Exclusion Criteria:

1) None.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671658

Contacts

Contact: Susan O'Brien, M.D.

713-745-4616

sobrien@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Susan O'Brien, M.D. 713-745-4616 sobrien@mdanderson.org
Principal Investigator: Susan O'Brien, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Susan O'Brien, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Susan O'Brien M.D./Professor )
Study ID Numbers:	ID02-230
Study First Received:	April 30, 2008
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00671658 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Lymphoma
HYPER-CVAD
Leukemia
Acute Lymphoblastic Leukemia
ALL
Remission Duration
Chemotherapy
Asparaginase

Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
Leukine
Methotrexate
Rituximab
Vincristine

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
Rituximab
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Antineoplastic Agents
Cyclophosphamide

ClinicalTrials.gov processed this record on February 08, 2010