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Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890656
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : August 23, 2011
Last Update Posted : February 20, 2012
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Study Start Date : June 2003
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890656

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Enzon Pharmaceuticals, Inc.
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Principal Investigator: Stefan F. Faderl, M.D. M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00890656    
Other Study ID Numbers: ID03-0166
First Posted: April 30, 2009    Key Record Dates
Results First Posted: August 23, 2011
Last Update Posted: February 20, 2012
Last Verified: February 2012
Keywords provided by M.D. Anderson Cancer Center:
Acute Lymphoblastic Leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents