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B-cell LymphomaPhase 2NCT00906841

Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma

A Phase 2 study testing 90Y-DOTA-hLL2 in people with B-cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase II, multi-centric, open-label, study. Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
B-cell Lymphoma
What is being tested?
90Y-DOTA-hLL2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteFrance
Study dates
Oct 2007to Apr 2018
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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 60 and < 80 years
  • Non eligible for stem cell transplantation
  • CD20 diffuse large B-cell lymphoma according to the WHO classification
  • Bulky stage I and II > ou =7 cm and stage III and IV
  • Performance status 0 - 2
  • Creatinine clearance >ou = 50 ml/min (Cockroft formula).
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  • Serum bilirubin < ou =30 mmol/l
  • Leucocytes > ou =3 G/l, granulocytes > ou = 1,5 G/l, platelets >ou= 100 G/L.
  • HIV negative
  • Written informed consent

Who cannot join

  • Age < 60 years and > 80 years
  • Other types of lymphomas except CD20+ diffuse large B-cell lymphoma according to the WHO classification
  • Histologic transformation of low grade lymphoma (Involvement of the bone marrow by small B-cell lymphoma will not lead to exclusion of the patient)
  • Primary lymphoma of the central nervous system and transformed gastro intestinal MALT lymphoma
  • Meningeal involvement
  • Bone marrow involvement > 25% after R-CHOP
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  • Aggressive post-transplantation lymphoma
  • Absence of CD20 expression on tumor cells
  • Non bulky stages I et II
  • HIV positive
  • Active Hepatitis B or C
  • Left ventricular ejection fraction < 50%.
  • Contra-indication to R-CHOP treatment
  • Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Participation at the same time in another study in which investigational drugs are used
  • Absence of written informed consent

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu/Clcc Nantes

    Nantes, 44093

Other trials in France

About this study

Official title: Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma

Phase II, multi-centric, open-label, study.

Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.

Read the detailed description

Initial treatment: 6 courses of CHOP-R 14 with evaluation of response before C4 (observation of no change or progression at this time will get the patient off study).

Consolidation : fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8).

Conditions
B-cell Lymphoma
Being tested
90Y-DOTA-hLL2
Keywords
Disseminated diffuse large B-cell lymphoma, first line treatment, R CHOP, 90Y-DOTA-hLL2, Patients older than 60 years
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • 90Y-DOTA-hLL2Drug

    Also called consolidation

    Consolidation : Fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)

Study groups in NCT00906841
Study groupRoleWhat they receive
90Y-DOTA-hLL2ExperimentalFractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)
Receives: Drug: 90Y-DOTA-hLL2

What is being measured

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

  1. Event free survival (EFS)

    Measured: EFS post treatment (at 2 years)

Secondary outcomes (3)

  1. Objective disease response (CR, CRu and PR), SD and disease progression

    Measured: OS after treatment

  2. Duration of response

    Measured: Time interval from the date on which a response (CR, CRu and PR)

  3. Time to disease progression

    Measured: Time interval from the date from initial of study treatment until the date on which disease progression is documented

Timeline

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

  1. First posted21 May 2009 (estimated)
  2. Study startOct 2007
  3. Primary completionMar 2016
  4. Study completionApr 2018

Why it stopped: completed recruitment of patients on 15 december 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906841
Sponsor's protocol ID
RIT90Y-DOTA-hLL2
Status last verified
Apr 2018
First submitted
18 May 2009
Last updated
27 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kraeber-Bodere F, Pallardy A, Maisonneuve H, Campion L, Moreau A, Soubeyran I, Le Gouill S, Tournilhac O, Daguindau E, Jardel H, Morineau N, Bouabdallah K, Gyan E, Moles MP, Gressin R, Berthou C, Sadot S, Moreau P, Deau B, Bodet-Milin C, Cazeau AL, Garin E, Salaun PY, Vuillez JP, Gouilleux-Gruart V, Barbet J, Wegener WA, Goldenberg DM, Lamy T, Soubeyran P. Consolidation anti-CD22 fractionated radioimmunotherapy with 90Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial. Lancet Haematol. 2017 Jan;4(1):e35-e45. doi: 10.1016/S2352-3026(16)30168-5. Epub 2016 Dec 8.

    PubMed 27964867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 90Y-DOTA-hLL2 in people with B-cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site 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 10 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Apr 2018. 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 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 was stopped early (reason given: completed recruitment of patients on 15 december 2010). 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?

Event free survival (EFS) (time frame: EFS post treatment (at 2 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 NCT00906841, 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 27 Apr 2018.

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