Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* 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.

Conditions

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Lymphoma

Keywords

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recurrent grade 3 follicular lymphoma recurrent adult diffuse large cell lymphoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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filgrastim

Intervention Type BIOLOGICAL

rituximab

Intervention Type BIOLOGICAL

carmustine

Intervention Type DRUG

cisplatin

Intervention Type DRUG

cytarabine

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

etoposide

Intervention Type DRUG

ifosfamide

Intervention Type DRUG

melphalan

Intervention Type DRUG

methotrexate

Intervention Type DRUG

bone marrow ablation with stem cell support

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

Age:

* 18 to 65

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 1 month since prior immunotherapy

Chemotherapy:

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

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 1 month since prior radiotherapy

Surgery:

* Not specified

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Edo Vellenga, MD

Role: STUDY_CHAIR

University Medical Center Groningen

Locations

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U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Site Status

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Site Status

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Medisch Centrum Leeuwarden - Zuid

Leeuwarden, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

Site Status

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

HagaZiekenhuis - Locatie Leyenburg

The Hague, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Isala Klinieken - locatie Sophia

Zwolle, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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Vellenga E, van Putten WL, van 't Veer MB, Zijlstra JM, Fibbe WE, van Oers MH, Verdonck LF, Wijermans PW, van Imhoff GW, Lugtenburg PJ, Huijgens PC. Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: a prospective randomized HOVON trial. Blood. 2008 Jan 15;111(2):537-43. doi: 10.1182/blood-2007-08-108415. Epub 2007 Oct 30.

Reference Type RESULT

PMID: 17971487 (View on PubMed)