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Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

This study has been completed.
Sponsor:
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00890656
First received: April 29, 2009
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  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 2

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 Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

Resource links provided by NLM:

U.S. FDA Resources

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

  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: February 17, 2012
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 May 23, 2013