Primary Non-Hodgkin-LymphomaPhase 2escZ-BEAMNCT00521560
A Study of Zevalin and Simultaneous Application of BEAM High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation in Refractory and Relapsed Aggressive Non-Hodgkin Lymphomas
A Phase 2 study testing Zevalin in people with Primary Non-Hodgkin-Lymphoma and Refractory Non-Hodgkin-Lymphoma, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.
Trial summary
Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Non-Hodgkin-Lymphoma, Refractory Non-Hodgkin-Lymphoma, CD20+ Aggressive Non-Hodgkin's Lymphoma
- What is being tested?
- Zevalin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Aug 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Age: 18 - 65 years
- Risk group: 1) Progression on primary therapy 2) Initial or subsequent relapse
- Histology: Diagnosis of relapsed aggressive non-Hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. The expression of the CD20 antigen must be demonstrated in the primary lesion or in the relapse. Specifically, the following entities can be treated in this study:
- B-NHL:
- Grade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)
- General condition: General condition ECOG 0-3 (Karnofsky: 40 - 100 %); for definition see Annex 14.10
- Presence of declaration of participation of the center and the patient's written consent form
Who cannot join
- Prior mediastinal or extensive abdominal irradiation
- Prior high-dose therapy and autologous stem cell transplantation
- Impairment of renal function (creatinine > 2.5 mg/dL, creatinine clearance < 20 mL/min)
- Impairment of hepatic function (bilirubin > 2.0 mg/dL, cholinesterase [CHE] < 2000 U/L)
- Impairment of pulmonary function (transfer lung factor for CO [TLCO] < 50 %, forced expiratory volume in 1 sec [FEV1] < 60 %, vital capacity [VC] < 60 %)
- Relevant deterioration of the above organ functions on salvage therapy
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- Failure of stem cell mobilization
- Active viral hepatitis
- HIV infection
- Other active or not conclusively curatively treated malignoma
- Severe concomitant psychiatric illness or suspected lack of patient compliance
- Pregnancy or unreliable contraception
- Highly dynamic progress of lymphoma (lactate dehydrogenase [LDH] > 1.5 x upper limit of normal [ULN]) after salvage therapy immediately prior to radioimmunotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)
Göttingen, 37075
About this study
Official title: Phase I/II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy With Simultaneous Application of Zevalin and BEAM Followed by Autologous Peripheral Stem Cell Transplantation in Relapsed and Refractory CD 20+ Non-Hodgkin's Lymphoma
Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma
- Conditions
- Primary Non-Hodgkin-Lymphoma, Refractory Non-Hodgkin-Lymphoma, CD20+ Aggressive Non-Hodgkin's Lymphoma
- Being tested
- Zevalin
- Keywords
- High-Dose Radio-Immuno- and Chemotherapy, stem cell transplantation, 90Y-Ibritumomab-Tiuxetan
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZevalinDrug
Also called 90Y-Ibritumomab-Tiuxetan
All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively.
High dose therapy will be given as BEAM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zevalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation.
Measured: 3 Year
Secondary outcomes (1)
Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startMar 2006
- Primary completionAug 2009
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Non-Hodgkin-LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertram Glass, Prof. Dr., Study director, German Society of Cancer e.V.Martin Gramatzki, MD PhD, Principal investigator, Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, GermanyMattias Witzens Harig, MD PhD, Principal investigator, Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, GermanyBernd Hertenstein, MD PhD, Principal investigator, Klinikum Bremen-Mitte gGmbH, Medizinische Klinik I, Bremen, GermanyGeorg Heß, MD PhD, Principal investigator, III Med., Schwerpunkt Hämatologie / Onkologie, Mainz, GermanyDorothea Kofahl-Krause, MD PhD, Principal investigator, MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, GermanyNorbert Schmitz, MD PhD, Principal investigator, Asklepios Klinik St. Georg, Hämatologische Abt., Hamburg, GermanyJörg Schubert, MD PhD, Principal investigator, Universitätskliniken d. Saarlandes, Med. I, Homburg/Saar, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521560
- Sponsor's protocol ID
- DSHNHL 2004-R4
- Other IDs
- DSHNHL 2004-R4
- Acronym
- escZ-BEAM
- Status last verified
- Feb 2013
- First submitted
- 27 Aug 2007
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy With Simultaneous Application of Zevalin and BEAM Followed by Autologous Peripheral Stem Cell Transplantation in Relapsed and Refractory CD 20+ Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00521560
- Acronym / sponsor ID
- escZ-BEAM / DSHNHL 2004-R4
- Conditions
- Primary Non-Hodgkin-Lymphoma, Refractory Non-Hodgkin-Lymphoma, CD20+ Aggressive Non-Hodgkin's Lymphoma
- Keywords
- High-Dose Radio-Immuno- and Chemotherapy, stem cell transplantation, 90Y-Ibritumomab-Tiuxetan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zevalin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 - 65 years
- Risk group: 1) Progression on primary therapy 2) Initial or subsequent relapse
- Histology: Diagnosis of relapsed aggressive non-Hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. The expression of the CD20 antigen must be demonstrated in the primary lesion or in the relapse. Specifically, the following entities can be treated in this study:
- Grade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)
- General condition: General condition ECOG 0-3 (Karnofsky: 40 - 100 %); for definition see Annex 14.10
Key exclusion criteria (13 listed)
- Prior mediastinal or extensive abdominal irradiation
- Prior high-dose therapy and autologous stem cell transplantation
- Impairment of renal function (creatinine > 2.5 mg/dL, creatinine clearance < 20 mL/min)
- Impairment of hepatic function (bilirubin > 2.0 mg/dL, cholinesterase [CHE] < 2000 U/L)
- Impairment of pulmonary function (transfer lung factor for CO [TLCO] < 50 %, forced expiratory volume in 1 sec [FEV1] < 60 %, vital capacity [VC] < 60 %)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZevalinAlso: 90Y-Ibritumomab-TiuxetanAll applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively. High dose therapy will be given as BEAM | Drug | 1 |
Primary outcome
The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation.
Time frame: 3 Year
1 secondary outcome
Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertram Glass, Prof. Dr. study director
German Society of Cancer e.V.
Martin Gramatzki, MD PhD principal investigator
Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, Germany
Mattias Witzens Harig, MD PhD principal investigator
Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zevalin in people with Primary Non-Hodgkin-Lymphoma and Refractory Non-Hodgkin-Lymphoma, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation. (time frame: 3 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2013.