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Mantle Cell LymphomaPhase 2NCT00285389

Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

A Phase 2 study testing Adriblastin, dexamethasone and Chlorambucil in people with Mantle Cell Lymphoma, run by French Innovative Leukemia Organisation at 3 sites in France.

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

Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Adriblastin, dexamethasone and Chlorambucil
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesFrance
Study dates
Feb 2002to Dec 2008
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

  • Mantel cell lymphoma
  • CD 20+
  • At diagnosis or without anterior chemotherapy
  • Age >18 and < 66 years
  • Ann Arbor ii, III or IV
  • ECOG <3
Show all 11Show fewer
  • contraindication for rituximab treatment
  • Informed consent signed
  • No cancer anteriory
  • Renal and hepatic function compatible with the treatment
  • Ventricular Fraction > 50 % with echographic method and > 40% with isotopic method

Who cannot join

  • Other type of lymphoma
  • age<18 ou > 66 years
  • Informed consent not signed
  • anterior cancer
  • Contraindication to rituximab
  • Cardiac insufficiency

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Regional university hospital

    Besançon, 25000

  • Regional university hospital

    Rennes, 35033

  • REgional Hospital

    Tours, 37000

Other trials in France

About this study

Official title: Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab

Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.

Read the detailed description

All patients at diagnosis with a stage II, III or IV an arbor disease are treated with 4 cycles of (R VAD +C) .

The responders more than RP > 50% received 2 other cycles before to be intensified with alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection.

There is an clinical and molecular evaluation of the strategy

Being tested
Adriblastin, dexamethasone, Chlorambucil, rituximab, cyclophosphamide
Keywords
Mantle cell lymphoma, Chemotherapy, Autologous PBSCT, Molecular evaluation
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

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

Study groups in NCT00285389
Study groupRoleWhat they receive
VAD Clorambucil RituximabExperimentalNot described
Receives: Drug: Adriblastin; Drug: dexamethasone; Drug: Chlorambucil; Drug: rituximab; Drug: cyclophosphamide; Drug: alkeran; Procedure: Total body irradiation (8Gy/4fr); Drug: vincristine

What is being measured

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

  1. failure event free survival at 3 years

    Measured: 3 YEARS

Secondary outcomes (5)

  1. Response rate after 4 R-(VAD+C) cycles

    Measured: 4 months

  2. Incident of Molecular residual disease on blood, marrow and stem cell collection

    Measured: 3 years

  3. Safety of the R-( VAD+C) regimen

    Measured: 8 months

  4. Overall survival

    Measured: 3 years

  5. Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging

    Measured: 8 months

Timeline

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

  1. First posted2 Feb 2006 (estimated)
  2. Study startFeb 2002
  3. Primary completionDec 2005
  4. Study completionDec 2008

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00285389
Sponsor's protocol ID
MANTEAU 2001
Status last verified
Feb 2009
First submitted
31 Jan 2006
Last updated
12 Feb 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. doi: 10.3324/haematol.2009.011759. Epub 2010 Mar 10.

    PubMed 20220059

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adriblastin, dexamethasone and Chlorambucil in people with Mantle Cell Lymphoma, run by French Innovative Leukemia Organisation at 3 sites in France.

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 11 inclusion and 6 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 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

failure event free survival at 3 years (time frame: 3 YEARS). 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 NCT00285389, 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 Feb 2009.

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