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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):	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 (CTX) Drug: Vincristine Drug: Doxorubicin Drug: Decadron Drug: G-CSF Drug: Methotrexate (MTX) Drug: Ara-C Drug: Pegaspargase	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

Resource links provided by NLM:

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

Primary Outcome Measures:

Number of Participants With Complete Remission [ Time Frame: Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses. ] [ Designated as safety issue: No ]
Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 * 10^9/L and a platelet count of ≥ 100 * 10^9/L with complete resolution of all sites of extramedullary disease required.

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

Arms	Assigned Interventions
Experimental: Augmented Hyper-CVAD Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.	Drug: Cyclophosphamide (CTX) 300 mg/m^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of Other Name: Cytoxan Drug: Vincristine 2 mg by vein (IV) weekly for 3: Days 1, 8, 15 Other Name: Oncovin® Drug: Doxorubicin 50 mg/m^2 by vein (IV) over 24 hours Other Name: Adriamycin® Drug: Decadron 80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18 Other Name: Dexamethasone Drug: G-CSF 10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours Other Name: Neupogen® Drug: Methotrexate (MTX) 200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1 Other Name: Rheumatrex® Drug: Ara-C 3 gm/m^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3. Other Name: Cytosar-U® Drug: Pegaspargase 2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses Other Names: PEG asparaginase Oncaspar Polyethylene Glycol Conjugated Lasparaginase-H

Arms

Assigned Interventions

Experimental: Augmented Hyper-CVAD

Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.

Drug: Cyclophosphamide (CTX)

300 mg/m^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of

Other Name: Cytoxan

Drug: Vincristine

2 mg by vein (IV) weekly for 3: Days 1, 8, 15

Other Name: Oncovin®

Drug: Doxorubicin

50 mg/m^2 by vein (IV) over 24 hours

Other Name: Adriamycin®

Drug: Decadron

80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18

Other Name: Dexamethasone

Drug: G-CSF

10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours

Other Name: Neupogen®

Drug: Methotrexate (MTX)

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

Other Name: Rheumatrex®

Drug: Ara-C

3 gm/m^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.

Other Name: Cytosar-U®

Drug: Pegaspargase

2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses

Other Names:

PEG asparaginase
Oncaspar
Polyethylene Glycol Conjugated Lasparaginase-H

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously treated acute lymphoblastic leukemia (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 (New York Heart Association (NYHA) < III as assessed by history and physical examination)

Exclusion Criteria:

Not Applicable

Contacts and Locations

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

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

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:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00890656 History of Changes
Other Study ID Numbers:	ID03-0166
Study First Received:	April 29, 2009
Results First Received:	July 25, 2011
Last Updated:	October 25, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute Lymphoblastic Leukemia
ALL
Leukemia
Hyper-CVAD

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Asparaginase
Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin

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

ClinicalTrials.gov processed this record on February 09, 2012