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Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's 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: NCT00012051
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: rituximab Drug: carmustine Drug: cisplatin Drug: cytarabine Drug: dexamethasone Drug: etoposide Drug: ifosfamide Drug: melphalan Drug: methotrexate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the partial and complete response rates in patients with relapsed, CD20 positive, aggressive B-cell non-Hodgkin's lymphoma treated with dexamethasone, cisplatin, and cytarabine in combination with etoposide, ifosfamide, and methotrexate with or without rituximab followed by carmustine, etoposide, cytarabine, melphalan, and autologous peripheral blood stem cell transplantation (APBSCT).
  • Compare the effect of APBSCT with or without rituximab on the overall and event-free survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive DHAP induction chemotherapy comprising dexamethasone orally or IV on days 1-4, cisplatin IV continuously over 24 hours on day 1, and cytarabine IV over 3 hours every 12 hours on day 2. Beginning 3-4 weeks after DHAP, patients receive VIM induction chemotherapy comprising etoposide IV over 2 hours on days 1, 3, and 5; ifosfamide IV over 1 hour on days 1-5; and methotrexate IV on days 1 and 5. Beginning 3-4 weeks after VIM, patients with partial or complete response after DHAP and VIM receive a second course of DHAP (patients with progressive or unresponsive disease after DHAP but responsive disease after VIM receive a second course of VIM) followed by filgrastim (G-CSF) subcutaneously beginning on day 10 and continuing until a target number of cells are collected.
  • Arm II: Patients receive induction chemotherapy and G-CSF as in arm I. At 1 day after the last dose of each chemotherapy course, patients also receive rituximab IV once for a maximum of 3 courses.

At 4-5 weeks after the completion of the last induction chemotherapy course, responsive patients in both arms receive BEAM conditioning chemotherapy comprising carmustine IV over 60 minutes on day -6, etoposide IV over 60 minutes and cytarabine IV over 30 minutes on days -5 to -2, and melphalan IV over 15 minutes on day -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0. After transplantation, patients in partial remission may undergo radiotherapy to nodal sites with residual tumor mass.

Patients are followed every 6 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 296-340 patients (148-170 per treatment arm) will be accrued for this study within 4-5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Phase III Study On The Effect Of The Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) During Sequential Chemotherapy Followed By Autologous Stem Cell Transplantation In Patients With Relapse B-Cell Non-Hodgkin Lymphoma(HOVON 44 STUDY)
Study Start Date : September 2000
Actual Study Completion Date : October 2007

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Response rate
  2. Event-free survival

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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL)

    • Diffuse large cell B-cell lymphoma
    • Grade III follicular center-cell lymphoma
    • Primary mediastinal B-cell lymphoma
  • CD20 positive
  • First relapse after doxorubicin containing regimen
  • Documented remission of at least 3 months after first-line chemotherapy
  • No Epstein-Barr virus post-transplantation lymphoproliferative disorder
  • No CNS involvement



  • 18 to 65

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • Not specified


  • No hepatic dysfunction
  • Bilirubin less than 2.5 times upper limit of normal (ULN)
  • Transaminases less than 2.5 times ULN


  • No renal dysfunction
  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 40 mL/min


  • No severe cardiac dysfunction
  • No New York Heart association class II-IV heart disease


  • No severe pulmonary dysfunction
  • Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement


  • No active uncontrolled infection
  • HIV negative
  • No intolerance to exogenous protein administration


Biologic therapy:

  • At least 1 month since prior immunotherapy


  • See Disease Characteristics
  • At least 1 month since prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 1 month since prior radiotherapy


  • Not specified

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): NCT00012051

Show Show 17 study locations
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
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Study Chair: Edo Vellenga, MD University Medical Center Groningen
Publications of Results:
Layout table for additonal information Identifier: NCT00012051    
Other Study ID Numbers: CKTO-2000-06
CDR0000068476 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: March 2007
Keywords provided by National Cancer Institute (NCI):
recurrent grade 3 follicular lymphoma
recurrent adult diffuse large cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Immunological
Immunologic Factors
Antirheumatic Agents