We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/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.
ClinicalTrials.gov Identifier: NCT00041327
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 3, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Antiviral therapy may kill viruses such as HTLV-1 that can cause cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult T-cell leukemia/lymphoma.

PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemia/lymphoma caused by HTLV-1.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: recombinant interferon alfa Drug: Etoposide Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lamivudine Drug: prednisone Drug: vincristine sulfate Drug: zidovudine Phase 2

Detailed Description:


  • Determine the efficacy of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH) followed by lamivudine, zidovudine, and interferon alfa, in terms of response rate, in patients with HTLV-1-associated adult T-cell leukemia/lymphoma.
  • Determine the duration of response in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the effect of this regimen on markers of virus replication and expression and immune function in these patients.

OUTLINE: This is a multicenter study.

Patients receive EPOCH chemotherapy comprising etoposide, vincristine, and doxorubicin IV continuously on days 1-5, cyclophosphamide IV over 30 minutes on day 5, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 7 and continuing until blood counts recover. Treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity, disease progression, or stable disease.

Beginning 1 month after completion of EPOCH, patients receive oral lamivudine and zidovudine twice daily and interferon alfa SC daily continuously for 1 year.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 10-32 patients will be accrued for this study within 1-2 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma
Study Start Date : October 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Intervention Details:
  • Biological: filgrastim
    5 ug/kg/d
    Other Name: Neupogen
  • Biological: recombinant interferon alfa
    9 mU subcutaneously per day for one year
  • Drug: Etoposide
    50 mg/m2/day continuous 96 hr infusion, days 1-4
    Other Name: VP-16
  • Drug: cyclophosphamide
    750 mg/m2 IV on day 5
    Other Name: cytoxan
  • Drug: doxorubicin hydrochloride
    10 mg/m2/day as a continuous 96-hour infusion days 1-4
    Other Name: adriamycin
  • Drug: lamivudine
    150 mg bid
    Other Name: epivir
  • Drug: prednisone
    60 mg/m2 given orally days 1-5
    Other Name: deltasone
  • Drug: vincristine sulfate
    0.4 mg/m2/day as a 96-hour continuous infusion days 1-4
    Other Name: Oncovin
  • Drug: zidovudine
    300 mg bid
    Other Name: AZT

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 60 days ]
  2. Duration of response [ Time Frame: 3 years ]
  3. Effects on markers of virus replication and expression and immune function [ Time Frame: 5 years ]
  4. Toxicity [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL)

    • Previously treated ATLL allowed
  • CD3-positive
  • Documented HTLV-1 infection by serologic assay (ELISA, Western blot)
  • Measurable or evaluable disease



  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,000/mm^3*
  • Platelet count greater than 75,000/mm^3* NOTE: *Unless cytopenia is secondary to ATLL


  • Transaminase less than 7 times upper limit of normal
  • Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir)


  • Creatinine less than 2.0 mg/dL (unless due to lymphoma)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study completion
  • No active opportunistic infection requiring acute therapy
  • No untreated thyroid disease
  • No autoimmune disease
  • No uncontrolled significant psychiatric disease
  • No other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer


Biologic therapy:

  • At least 24 hours since prior hematologic growth factors


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • Concurrent chronic therapy with potentially myelosuppressive agents allowed
  • Other concurrent antiretroviral therapy for HIV, hepatitis B, or hepatitis C infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation

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 ClinicalTrials.gov identifier (NCT number): NCT00041327

Layout table for location information
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Lee Ratner, MD, PhD Washington University Siteman Cancer Center
Publications of Results:
Layout table for additonal information
Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00041327    
Other Study ID Numbers: AMC-033
U01CA070019 ( U.S. NIH Grant/Contract )
CDR0000069469 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by AIDS Malignancy Consortium:
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists