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

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: NCT00290433
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : July 14, 2015
Ortho Biotech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma Drug: Cyclophosphamide Drug: Mesna Drug: Vincristine Drug: Methotrexate Drug: Ara-C Drug: Dexamethasone Drug: G-CSF Drug: Doxil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2003
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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): NCT00290433

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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.
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Principal Investigator: Yasuhiro Oki, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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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 )
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by M.D. Anderson Cancer Center:
Peripheral T Cell
Cytosine arabinosine hydrochloride
Pegylated Liposomal Doxorubicin
Doxorubicin hydrochloride
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists