Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like 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: NCT00392990
Recruitment Status : Active, not recruiting
First Posted : October 26, 2006
Last Update Posted : March 16, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Regimen A Drug: Regimen B Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study Incorporating DOXIL® and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitt's and Burkitt-like Lymphoma
Study Start Date : October 2006
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Alternating doxil/Magrath regimen & rituximab/Magrath regimen
Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.
Drug: Regimen A
Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
Other Names:
  • Rituximab
  • Doxil
  • pegylated liposomal doxorubicin
  • cyclophosphamide
  • Cytoxan®
  • CTX
  • CPM
  • Neosar®
  • Vincristine
  • Oncovin®
  • Vincasar PFS®
  • vincristine sulphate
  • VCR
  • leucocristine
  • LCR
  • Methotrexate
  • Methotrexate sodium
  • MTX
  • Mexate
  • Mexate-AQ
  • Folex
  • Folex PFS
  • Abitrexate
  • Rheumatrex
  • Amethopterin

Drug: Regimen B
Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
Other Names:
  • Rituximab
  • Ifosfamide
  • Ifex®
  • Etoposide
  • VP-16
  • VePesid®
  • VP-16-213
  • EPEG
  • epipodophyllotoxin
  • NSC # 141540
  • Cytarabine
  • Cytosar-U
  • Ara-C
  • Arabinosyl
  • cytosine arabinoside

Primary Outcome Measures :
  1. Response rate: complete remission rate [ Time Frame: every 6 months up to two years after treatment completion ]
    Response rate will be accessed by CT scans every six months up to two years following completion of treatment

  2. Overall response rate: disease free and overall survival [ Time Frame: every six months up to two years following treatment completion ]
    Overall response rate (including disease free and overall survival)will be assessed by CT scans every six months up to two years following treatment completion

Secondary Outcome Measures :
  1. Safety of Rituximab plus Magrath regimen in HIV negative and HIV positive subjects [ Time Frame: Regimen A prior to cycles 1 and 3; Regimen B prior to cycles 2 and 4; 30 days after completion of treatment ]
    adverse events will be assessed as follows: Regimen A prior to cycles 1 and 3; Regimen B prior to cycles 2 and 4; 30 days after completion of treatment

  2. Safety of using doxil in place of adriamycin [ Time Frame: Regimen A prior to cycles 1 and 3 and 30 days after completion of treatment ]
    Adverse events will be assessed as follows: Regimen A prior to cycles 1 and 3 and 30 days after completion of treatment

  3. Safety of using lower intravenous methotrexate dosing [ Time Frame: Regimen A prior to cycles 1 and 3 and 30 days after completion of treatment ]
    Adverse events will be assessed as follows: Regimen A prior to cycles 1 and 3 and 30 days after completion of treatment

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


  • Histologically confirmed Burkitt's or Burkitt-like non-Hodgkin's lymphoma meeting 1 of the following risk criteria:

    • Low-risk disease meeting all of the following criteria:

      • Normal lactate dehydrogenase level
      • ECOG performance status 0-1
      • Ann Arbor stage I or II
      • No tumor mass over 10 cm in greatest diameter
    • High-risk disease, defined as disease not meeting low-risk criteria
  • Newly diagnosed disease


  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 500/mm³
  • Platelet count ≥ 100,000/mm³ (50,000/mm³ if bone marrow involvement is documented)
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
  • Creatinine clearance > 50 mL/min
  • Creatinine ≤ 2.0 mg/dL
  • LVEF ≥ 45% by MUGA scan or echocardiogram
  • No New York Heart Association class II-IV heart failure
  • No clinically significant pericardial disease
  • No myocardial infarction within the past 6 months
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No ECG evidence of acute ischemia or active conduction system abnormalities

    • Investigator must document any baseline ECG abnormality as not medically relevant
  • No other malignancy within the past year except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No other serious medical or psychiatric illness that would preclude study compliance


  • Prior treatment with 1 course of any combination of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and/or prednisone* (CHOP)-like therapy allowed, provided the following doses are not exceeded:

    • Rituximab 750 mg/m²
    • Cyclophosphamide 1,000 mg/m²
    • Doxorubicin hydrochloride 50 mg/m²
    • Vincristine 2 mg/m²
  • No other investigational drugs within the past 14 days
  • No other concurrent systemic, cytotoxic, investigational, or chemotherapy agents NOTE: *No maximum dose restriction on steroids

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): NCT00392990

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
John H. Stroger Cook County Hospital
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Leo Gordon, MD Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Northwestern University Identifier: NCT00392990     History of Changes
Other Study ID Numbers: NU 06H2
P30CA060553 ( U.S. NIH Grant/Contract )
NU 06H2 ( Other Identifier: Northwestern University )
CDR0000509706 ( Registry Identifier: PDQ )
STU00004480 ( Other Identifier: Northwestern University IRB )
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Northwestern University:
stage I adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma
AIDS-related peripheral/systemic lymphoma

Additional relevant MeSH terms:
Burkitt Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating