AzTrials
AzTrials

LymphomaPhase 3NCT00025636

Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma

A Phase 3 study testing filgrastim, carmustine and cisplatin in people with Lymphoma, run by German Hodgkin's Lymphoma Study Group at 44 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, carmustine and cisplatin
Type of treatment
Surgery or procedure
How many people
220 participants
Where
44 sitesin 8 countries
Study dates
Jul 2001to not given
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma
  • Early or late first relapse
  • Complete or partial remission for at least 3 months after completion of prior COPP/ABVD, COPP/ABV/IMEP, MOPP/ABV, ABVD, BEACOPP, or other polychemotherapy regimen with or without radiotherapy
  • No prior salvage therapy OR
  • Second relapse
  • Any prior salvage therapy
  • No prior high-dose chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 to 60

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-2

Life expectancy:

  • More than 3 months with treatment

Hematopoietic:

  • Absolute neutrophil count at least 2,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg)
  • No unstable angina
  • No New York Heart Association class III or IV heart disease (congestive heart failure)
  • No myocardial infarction within the past 6 months
  • No uncontrolled atrial or ventricular cardiac arrhythmias

Pulmonary:

  • No chronic pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No poorly controlled diabetes
  • No cerebral disorder
  • No other concurrent malignancy except adequately treated basal cell skin cancer or cervical intraepithelial neoplasia
  • No significant non-malignant disease
  • No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Other:

  • At least 6 months since prior coronary angioplasty
  • No other concurrent investigational drugs
  • No concurrent non-steroidal anti-inflammatory drugs, salicylate, sulfonamide, trimethoprim, allopurinol, aminoglycoside, amoxicillin, or probenecid during high-dose methotrexate administration

Trial locations and contacts

44 sites in 8 countries.

44 sites in 8 countries

Germany27 sites

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Charite - Campus Virchow Klinikum

    Berlin, D-13353

  • Medizinische Poliklinik

    Bonn, D-53111

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Staedtisches Klinikum Dessau

    Dessau, D-06822

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Evangelisches Krankenhaus Essen Werden

    Essen, D-45239

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17475

  • Martin Luther Universitaet

    Halle, D-06120

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246

  • Evangelische Krankenhaus Hamm

    Hamm, DOH-59063

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Medizinische Universitaetsklinik und Poliklinik

    Heidelberg, 69115

  • St. Bernward Krankenhaus

    Hildeshem, D-31134

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, D-07740

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, D-23538

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

Other trials in Germany

Netherlands8 sites

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • Maxima Medisch Centrum - Veldhoven

    Veldhoven, 5500 MB

Other trials in Netherlands

Belgium4 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Algemeen Ziekenhuis Sint Lucas

    Ghent, B-9000

Other trials in Belgium

Croatia1 site

  • University Hospital Rebro

    Zagreb, 10000

Other trials in Croatia

Denmark1 site

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen, 2100

Other trials in Denmark

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Portugal1 site

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, P-3001-301

Other trials in Portugal

Switzerland1 site

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of induction chemotherapy followed by combination chemotherapy and autologous peripheral blood stem cell transplantation with or without high-dose sequential chemotherapy in terms of freedom from treatment failure in patients with relapsed Hodgkin's lymphoma.
  • Compare the toxicity of these regimens in these patients.
  • Compare the complete remission/unconfirmed complete remission rate at 3 months, relapse-free survival, and overall survival of patients treated with these regimens.
  • Compare the frequency of severe toxic effects and secondary neoplasia in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse [remission duration 3-12 months] vs late first relapse [remission duration more than 12 months] vs second relapse without prior high-dose chemotherapy salvage [remission duration after salvage at least 3 months]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change).

All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms.

  • Arm I: Patients receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 37 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 37-40. Patients also receive G-CSF SC twice daily beginning on day 41 and continuing until blood counts recover. Autologous peripheral blood stem cells (PBSCs) are reinfused on day 42.
  • Arm II: Patients receive high-dose cyclophosphamide IV over 8 hours on day 37, high-dose methotrexate IV over 6 hours and high-dose vincristine IV on day 51, and high-dose etoposide IV over 8 hours on days 58-61. Patients then receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 80 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 80-83. Patients also receive G-CSF SC once on days 38 and 62 and twice daily beginning on day 84 and continuing until blood counts recover. Autologous PBSCs are reinfused on day 85.

Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy.

Patients are followed at 100 days after PBSC transplantation, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 220 patients (110 per treatment arm) will be accrued for this study within 5 years.

Conditions
Lymphoma
Being tested
filgrastim, carmustine, cisplatin, cyclophosphamide, cytarabine
Keywords
recurrent adult Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

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. Efficacy at 3 months

  2. Toxicity at 3 months

Secondary outcomes (3)

  1. Complete remission at 3 months

  2. Relapse-free survival at 3 months

  3. Overall survival at 3 months

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 startJul 2001

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
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025636
Sponsor's protocol ID
CDR0000068981
Other IDs
GHSG-HD-R2, EBMT-GHSG-HD-R2, EORTC-20011
Status last verified
Jun 2007
First submitted
11 Oct 2001
Last updated
17 Sep 2013
Results posted
No

Publications

  • Brockelmann PJ, Muller H, Casasnovas O, Hutchings M, von Tresckow B, Jurgens M, McCall SJ, Morschhauser F, Fuchs M, Borchmann P, Moskowitz CH, Engert A. Risk factors and a prognostic score for survival after autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma. Ann Oncol. 2017 Jun 1;28(6):1352-1358. doi: 10.1093/annonc/mdx072.

    PubMed 28327958

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, carmustine and cisplatin in people with Lymphoma, run by German Hodgkin's Lymphoma Study Group at 44 sites in 8 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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Germany, Netherlands, Belgium, Croatia, Denmark and 3 more countries. 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?

Results are not available in the source record.

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?

Efficacy at 3 months. The study lists 2 primary outcomes in all. 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 NCT00025636, 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 17 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in