Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Enzon Pharmaceuticals, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00890656

Purpose

The goal of this clinical research study is to learn if a special combination of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety of this therapy will also be studied.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Cyclophosphamide Drug: Vincristine Drug: Doxorubicin Drug: Decadron Drug: G-CSF Drug: Methotrexate Drug: Ara-C	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Dexamethasone Cyclophosphamide Vincristine Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Granulocyte colony-stimulating factor Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

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

Primary Outcome Measures:

Complete remission rate [ Time Frame: June 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality and toxicity rate [ Time Frame: June 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	June 2003
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cyclophosphamide Vincristine Doxorubicin Dexamethasone G-CSF Methotrexate ARA-C	Drug: Cyclophosphamide Cyclophosphamide (CTX) 300 mg/m^2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 Drug: Vincristine Vincristine 2 mg IV weekly x 3: Days 1, 8, 15 Drug: Doxorubicin Doxorubicin 50 mg/m^2 IV over 24 hours Drug: Decadron Decadron 80 mg IV or P.O. daily days 1-4 and 15-18 Drug: G-CSF G-CSF 10 mcg/kg/day (rounded) within 72 ± 48 hours Drug: Methotrexate Methotrexate (MTX) 200 mg/m2 IV over 2 hours followed by 800 mg/m2 over 22 hours on day 1 Drug: Ara-C Ara-C 3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2 and 3.

Arms

Assigned Interventions

1: Experimental

Cyclophosphamide Vincristine Doxorubicin Dexamethasone G-CSF Methotrexate ARA-C

Drug: Cyclophosphamide

Cyclophosphamide (CTX) 300 mg/m^2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3

Drug: Vincristine

Vincristine 2 mg IV weekly x 3: Days 1, 8, 15

Drug: Doxorubicin

Doxorubicin 50 mg/m^2 IV over 24 hours

Drug: Decadron

Decadron 80 mg IV or P.O. daily days 1-4 and 15-18

Drug: G-CSF

G-CSF 10 mcg/kg/day (rounded) within 72 ± 48 hours

Drug: Methotrexate

Methotrexate (MTX) 200 mg/m2 IV over 2 hours followed by 800 mg/m2 over 22 hours on day 1

Drug: Ara-C

Ara-C 3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2 and 3.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory;
No age restrictions;
Zubrod performance status </= 3;
Adequate liver (bilirubin </= 3mg/dl unless considered due to tumor) and renal function (creatinine </= 3mg/dl unless considered due to tumor);
Adequate cardiac function (NYHA < III as assessed by history and physical examination)

Exclusion Criteria:

NA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890656

Contacts

Contact: Stefan F. 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 F. Faderl, M.D. 713-745-4613 sfaderl@mdanderson.org
Principal Investigator: Stefan F. Faderl, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Enzon Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Stefan F. Faderl, 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 ( Stefan Faderl, M.D./Associate Professor )
Study ID Numbers:	ID03-0166
Study First Received:	April 29, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00890656 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute Lymphoblastic Leukemia
ALL
Leukemia
Hyper-CVAD

Study placed in the following topic categories:

Dexamethasone
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Cyclophosphamide
Leukemia
Anti-Bacterial Agents
Hyperkinesis
Methotrexate
Lymphoma
Alkylating Agents
Dexamethasone acetate
Cytarabine
Acute Lymphoblastic Leukemia

Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Vincristine
Antimitotic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Doxorubicin
Folic Acid
Lymphatic Diseases
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Leukemia
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents

Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009