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AzTrials

LymphomaPhase 3NCT00012051

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

A Phase 3 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by Commissie Voor Klinisch Toegepast Onderzoek at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and carmustine
Type of treatment
Surgery or procedure
How many people
340 participants
Where
17 sitesin 2 countries
Study dates
Sep 2000to Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

Netherlands16 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL

  • Meander Medisch Centrum

    Amersfoort, 3816 CP

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 BE

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081HV

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • University Medical Center Groningen

    Groningen, 9713 EZ

  • Medisch Centrum Leeuwarden - Zuid

    Leeuwarden, 8934 AD

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • HagaZiekenhuis - Locatie Leyenburg

    The Hague, 2545 CH

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Isala Klinieken - locatie Sophia

    Zwolle, 8000 GK

Other trials in Netherlands

Belgium1 site

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

About this study

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)

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.

Read the detailed description

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
Lymphoma
Being tested
filgrastim, rituximab, carmustine, cisplatin, cytarabine
Keywords
recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (2)

  1. Response rate

  2. Event-free survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2000
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00012051
Sponsor's protocol ID
CKTO-2000-06
Other IDs
CDR0000068476, HOVON-44, HOVON-44/CKVO-2000-06, EU-20042, ISRCTN95614846
Status last verified
Mar 2007
First submitted
3 Mar 2001
Last updated
12 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 17971487

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by Commissie Voor Klinisch Toegepast Onderzoek at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00012051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.

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