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Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

This study has been completed.
Ortho Biotech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: February 10, 2006
Last updated: July 13, 2015
Last verified: July 2015
The goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma.

Condition Intervention Phase
Drug: Cyclophosphamide
Drug: Mesna
Drug: Vincristine
Drug: Methotrexate
Drug: Ara-C
Drug: Dexamethasone
Drug: G-CSF
Drug: Doxil
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 41 days ]
    Progression-free survival measured from start of first cycle of chemotherapy to first detection of disease progression.

Enrollment: 55
Study Start Date: September 2003
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCVIDDOXIL Regimen

Cycle 1: Cyclophosphamide by vein two times a day on Days 1,2, and 3. Mesna by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin by vein over 1 hour on Day 2. Vincristine by vein on Days 4 and 11. Dexamethasone by mouth on Days 1 through 4 and 11 through 14.

Cycle 2: Methotrexate by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine by vein twice a day on Days 2 and 3.

Drug: Cyclophosphamide
Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.
Other Names:
  • Cytoxan
  • Neosar
Drug: Mesna
Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3.
Drug: Vincristine
Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11.
Drug: Methotrexate
Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.
Drug: Ara-C
Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.
Other Names:
  • Cytarabine
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride
Drug: Dexamethasone
Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.
Other Name: Decadron
Drug: G-CSF
Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.
Other Names:
  • Filgrastim
  • Neupogen
Drug: Doxil
Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2.
Other Names:
  • Pegylated Liposomal Doxorubicin
  • Doxorubicin hydrochloride (lipsomal)

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK lymphomas, with the exception of cluster of differentiation antigen 30 (CD30+) alk1+ T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also excluded. For patients with skin involvement as part of systemic disease, prior topical treatment only is allowed.
  2. Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).
  3. Serum bilirubin </= 1.5 mg/dl and serum creatinine </= 2.0 mg/dl unless due to lymphoma; Absolute neutrophil count (ANC) >/= 1000 mm^3 and platelets >/= 100,000 mm^3 unless due to lymphoma.
  4. Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA) or echocardiogram.
  5. Ages 18 and older.
  6. Patients must be willing to receive transfusions of blood products.

Exclusion Criteria:

  1. Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone.
  2. Pregnancy
  3. HIV positive serology
  4. Central nervous system (CNS) involvement
  5. Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator
  6. Concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00290433

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Ortho Biotech, Inc.
Principal Investigator: Yasuhiro Oki, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00290433     History of Changes
Other Study ID Numbers: ID03-0004
NCI-2010-00445 ( Registry Identifier: NCI CTRP )
Study First Received: February 10, 2006
Last Updated: July 13, 2015

Keywords provided by M.D. Anderson Cancer Center:
Peripheral T Cell
Cytosine arabinosine hydrochloride
Pegylated Liposomal Doxorubicin
Doxorubicin hydrochloride

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Liposomal doxorubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 24, 2017