Mantle-Cell LymphomaPhase 2HD-MCL2003NCT00946374
Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
A Phase 2 study testing Immunochemotherapy, High-dose BEAM plus autologous SCT and HLA-identical allogenic SCT in people with Mantle-Cell Lymphoma, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by a new concept of treatment with primary curative intention consisting of six courses of immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (SCT) and HLA-identical allogenic SCT… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mantle-Cell Lymphoma
- What is being tested?
- Immunochemotherapy, High-dose BEAM plus autologous SCT and HLA-identical allogenic SCT
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Jun 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
- Age 18 to 55 years
- Confirmed CD20-expression on lymphocytes
- Effective methods of contraception and negative pregnancy test
- Sufficient compliance
- Written patient´s informed consent
Who cannot join
- Manifest cardiac insufficiency, not compensated
- Congestive Cardiomyopathy
- Chronic pulmonary disease including hypoxemia
- Severe hypertension, not condensable with drugs
- Severe diabetes mellitus not condensable with drugs
- Renal Insufficiency ( serum creatinin > 2,0 mg/dl, other than Lymphoma related)
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- Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin > 2,0 mg/dl, other than Lymphoma related)
- HIV-Infection
- Active Hepatitis B-Infection if continuous virostatic treatment is not possible
- Active Hepatitis C-Infection
- Clinical signs of cerebrovascular insufficiency or cerebral damages
- Pregnancy, lactation or inadequate contraception in women of childbearing age
- Severe psychiatric disorders
- Transplantation in the past
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Heidelberg, 69120
Markus Munder, MD
About this study
Official title: A Prospective Phase II Trial on R-CHOP Followed by High-dose BEAM and Autologous SCT and HLA-identical Allogenic SCT After Dose-reduced Conditioning in Patients Age < 55 Years With Primary Mantle-Cell-Lymphoma
The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by a new concept of treatment with primary curative intention consisting of six courses of immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with primary Mantle-Cell-Lymphoma
Read the detailed description
With a median overall survival of approximately 3 years, MCL has the poorest prognosis of all NHL entities. No potentially curative therapy has been established yet as even more intensive therapies including high-dose chemotherapy plus autologous SCT show only moderate improvement of the prognosis of MCL. Allogenic SCT seems to have an immunological mechanism of action in NHL, which is commonly known as Graft-versus-Lymphoma effect. This trial´s purpose is to improve the overall survival in patients younger than 55 years with primary MCL by sequentially combining autologous SCT and allogenic SCT after the application of 6 courses of immunochemotherapy and high-dose chemotherapy.
- Conditions
- Mantle-Cell Lymphoma
- Being tested
- Immunochemotherapy, High-dose BEAM plus autologous SCT, HLA-identical allogenic SCT
- Keywords
- Mantle-Cell-Lymphoma, MCL, Non Hodgkin´s Lymphoma, NHL, Immunochemotherapy, R-CHOP, CHOP, High-dose chemotherapy, BEAM, HD-BEAM, Autologous stem cell transplantation, Reduced conditioning regimen, Unrelated donor, Sibling donor, Total Body Irradiation, TBI, Allogenic stem cell transplantation, ABSCT, ASCT, Fludarabine+TBI
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunochemotherapyDrug
Also called R-CHOP, CHOP, MabThera®, Endoxan®
R-CHOP: Rituximab 375 mg/m²,intravenous ( iv ), day 0 ; Cyclophosphamide 750 mg/m²,iv, day1; Vincristine 1,4 mg/m² but at the maximum 2 mg,iv,d1; Doxorubicin 50 mg/m², iv, d1; Prednisone 100 mg, peroral ( po ), day 1 to day 5
High-dose BEAM plus autologous SCTDrug
Also called BEAM, High-dose BEAM, ABSCT, ASCT
High-dose BEAM: Carmustine 300mg/m², iv, day -7; Cytarabine 2 x 200 mg/m², iv, day -6 to day -3; Etoposide 2 x 100 mg/m², iv, day -6 to day -3; Melphalan 140 mg/m², iv, day -2 followed by Autologous stem cell transplantation ( > 2,5 x 10e6 CD34 positive autologous stem cells, iv, day 0
HLA-identical allogenic SCTOther
Also called Sibling donor, Unrelated donor, HLA-identical, Conditioning regimen
Fludarabine 30 mg/m², iv, day -4 to day -2; Cyclosporin A 2 x 3mg/kg, iv, day -1 to day 0 plus total body irradiation with 2 Gy, day 0 followed by allogenic stem cell transplantation immediately after Radiation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: ORR, OS, EFS
Measured: during treatment and on day 720 after allogenic SCT
Secondary outcomes (3)
Toxicity according to WHO-Grading
Measured: During treatment and until follow-up
GvL-effect after allogenic SCT
Measured: Allogenic SCT until day 720 after transplantation
Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT
Measured: First diagnosis of MCL until day 720 after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2004
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle-Cell 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Anthony D. Ho, Ph.D., Prof., Principal investigator, Director of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946374
- Sponsor's protocol ID
- L-149/2003
- Other IDs
- BfArM: A-7140-00-37/4021157
- Acronym
- HD-MCL2003
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Trial on R-CHOP Followed by High-dose BEAM and Autologous SCT and HLA-identical Allogenic SCT After Dose-reduced Conditioning in Patients Age < 55 Years With Primary Mantle-Cell-Lymphoma
- ClinicalTrials.gov ID
- NCT00946374
- Acronym / sponsor ID
- HD-MCL2003 / L-149/2003
- Conditions
- Mantle-Cell Lymphoma
- Keywords
- Mantle-Cell-Lymphoma, MCL, Non Hodgkin´s Lymphoma, NHL, Immunochemotherapy, R-CHOP, CHOP, High-dose chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 27 Jul 2009 (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.
The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by a new concept of treatment with primary curative intention consisting of six courses of immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with primary Mantle-Cell-Lymphoma
Detailed description
With a median overall survival of approximately 3 years, MCL has the poorest prognosis of all NHL entities. No potentially curative therapy has been established yet as even more intensive therapies including high-dose chemotherapy plus autologous SCT show only moderate improvement of the prognosis of MCL. Allogenic SCT seems to have an immunological mechanism of action in NHL, which is commonly known as Graft-versus-Lymphoma effect. This trial´s purpose is to improve the overall survival in patients younger than 55 years with primary MCL by sequentially combining autologous SCT and allogenic SCT after the application of 6 courses of immunochemotherapy and high-dose chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
- Age 18 to 55 years
- Confirmed CD20-expression on lymphocytes
- Effective methods of contraception and negative pregnancy test
- Sufficient compliance
Key exclusion criteria (14 listed)
- Manifest cardiac insufficiency, not compensated
- Congestive Cardiomyopathy
- Chronic pulmonary disease including hypoxemia
- Severe hypertension, not condensable with drugs
- Severe diabetes mellitus not condensable with drugs
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 |
|---|---|---|
| ImmunochemotherapyAlso: R-CHOP, CHOP, MabThera®, Endoxan®R-CHOP: Rituximab 375 mg/m²,intravenous ( iv ), day 0 ; Cyclophosphamide 750 mg/m²,iv, day1; Vincristine 1,4 mg/m² but at the maximum 2 mg,iv,d1; Doxorubicin 50 mg/m², iv, d1; Prednisone 100 mg, peroral ( po ), day 1 to day 5 | Drug | – |
| High-dose BEAM plus autologous SCTAlso: BEAM, High-dose BEAM, ABSCT, ASCTHigh-dose BEAM: Carmustine 300mg/m², iv, day -7; Cytarabine 2 x 200 mg/m², iv, day -6 to day -3; Etoposide 2 x 100 mg/m², iv, day -6 to day -3; Melphalan 140 mg/m², iv, day -2 followed by Autologous stem cell transplantation ( > 2,5 x 10e6 CD34 positive autologous stem cells, iv, day 0 | Drug | – |
| HLA-identical allogenic SCTAlso: Sibling donor, Unrelated donor, HLA-identical, Conditioning regimenFludarabine 30 mg/m², iv, day -4 to day -2; Cyclosporin A 2 x 3mg/kg, iv, day -1 to day 0 plus total body irradiation with 2 Gy, day 0 followed by allogenic stem cell transplantation immediately after Radiation. | Other | – |
Primary outcome
Efficacy: ORR, OS, EFS
Time frame: during treatment and on day 720 after allogenic SCT
3 secondary outcomes
Toxicity according to WHO-Grading
Time frame: During treatment and until follow-up
GvL-effect after allogenic SCT
Time frame: Allogenic SCT until day 720 after transplantation
Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT
Time frame: First diagnosis of MCL until day 720 after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
- Homepage University hospital Heidelberg, GermanyLink provided by the sponsor.
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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.
Anthony D. Ho, Ph.D., Prof. principal investigator
Director of Department
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 Immunochemotherapy, High-dose BEAM plus autologous SCT and HLA-identical allogenic SCT in people with Mantle-Cell Lymphoma, run by Heidelberg University 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Jul 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Munder, M. D. (0049 6221 56 ext. 32370, markus.munder@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: ORR, OS, EFS (time frame: during treatment and on day 720 after allogenic SCT). 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 27 Jul 2009.