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Diffuse Large B-Cell LymphomaPhase 1/2NCT01562990

Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse

A Phase 1/2 study testing Rituximab, CMC544, Gemcitabine and Oxaliplatine in people with Diffuse Large B-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 11 sites in 2 countries.

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

The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Rituximab, CMC544, Gemcitabine and Oxaliplatine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
11 sitesin 2 countries
Study dates
Dec 2012to Mar 2016
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically documented CD20 and CD22 positive diffuse large B-cell lymphoma, according to WHO classification. CD20 and CD22 immunophenotyping at initial diagnosis is acceptable. If such prior documentation is not available, then the immunophenotyping at relapse must be established by fine-needle aspirate or biopsy or by circulating CD20 and CD22 positive NHL cells from peripheral blood during screening. Upon registration the pathological report confirming the diagnosis, must be available
  • In first or second relapse or refractory to first and/or second line treatment. Refractory is defined as having exhibited less than or PR to a prior rituximab containing regimen or having relapsed within 6 months of the last dose of a prior rituximab containing regimen.
  • Measurable disease by bidimensional transverse CT scan assessment
  • Not eligible for autologous transplantation.
  • Previously treated with a chemotherapy regimen containing anthracyclines and rituximab.
  • Aged 18 - 80 years.
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  • ECOG performance status 0 to 2.
  • Minimum life expectancy of 3 months.
  • Signed written informed consent.

Who cannot join

  • Burkitt, mantle cell and T-cell lymphomas.
  • Central nervous system or meningeal involvement by the lymphoma.
  • Contraindication to any drug contained in the R-GEMOX combination chemotherapy.
  • Treatment with any investigational drug within 30 days before the first planned cycle of chemotherapy and during the study.
  • Nitrosurea or mitomycin C administration within 6 weeks prior to study start.
  • Major debulking surgery within 3 weeks of treatment.
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  • Any of the following lab abnormalities (unless related to the lymphoma or bone marrow infiltration):
  • Absolute neutrophil count (ANC) < 1.500/µL (1,5.109/L).
  • Platelet count < 100.000/µL (100.109/L).
  • Creatinin level > 150 µmol/L (1,7 mg/dL) or 1,5 - 2,0x ULN.
  • Total bilirubin level > 30 µmol/L (1,8 mg/dL) or 1,5x ULN.
  • Serum AST/SGOT or ALT/SGPT >2,5x ULN.
  • Documented infection with HIV, active hepatitis B or C infection.
  • Any serious active disease or co-morbid medical condition that, according to the investigator's decision, will substantially increase the risk associated with the subject's participation in the study. Prior history of malignancies other than lymphoma with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or stage 0 (in situ) cervical carcinoma unless the subject has been disease-free for 5 or more years..
  • LVEF less than 50% (measured by echocardiography or scintigraphy).
  • Previous myocardial infarction or pulmonary hypertension within 6 months before the first dose of investigational product.
  • Congestive heart failure NYHA stage III or IV
  • Known chronic liver disease (eg. Cirrhosis) or suspected alcohol abuse.
  • Pregnant or lactating females
  • Men and women who are biologically capable of having children not willing to use an adequate method of birth control during the study and up to 18 months after the last dose of investigational product.
  • Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

France8 sites

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21000

  • CHRU de Lille

    Lille, 59037

  • CHU Lyon - Sud

    Lyon, 69495

  • CHU Hôtel Dieu

    Nantes, 44093

  • CHU Pontchaillou

    Rennes, 35003

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Belgium3 sites

  • AZ Sint Jan

    Bruges, 8000

  • University Hospital Gent

    Ghent, 9000

  • CHU Mont-Godinne

    Yvoir

Other trials in Belgium

About this study

Official title: A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-cell Lymphoma (DLBCL) in Relapse After/Refractory to 1ST or 2ND Line Treatment, Who Are no Candidates for Autologous Transplant.

The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

Read the detailed description

This study is a multicenter, phase Ib/II, open-label, single arm trial evaluating the efficacy and safety of R-CMC544 alternated with R-GEMOX in patients with CD20 and CD22 positive DLBCL in relapse after/refractory to 1st or 2nd line treatment, who are no candidates for autologous transplant.

The study consists of 2 phases. In part 1 (potential dose de-escalation phase) subjects will be enrolled at a fixed dose of CMC544. In case of occurrence of dose limiting toxicity (DLT), cohorts of 3 to 6 subjects will evaluate a de-escalating dose of CMC544 in combination with set doses of rituximab, gemcitabine and oxaliplatin in order to obtain the MTD or recommended dose of CMC544 in this regimen. In part 2 (dose expansion phase) further safety and preliminary efficacy data of the proposed combination will be analyzed.

All patients will receive two 56 day induction cycles of alternating R-CMC544 (given on day 1) and R-GEMOX (given on day 29 and 43). Patients who obtain CR or PR, will then go on a consolidation of another two 56 day cycles of alternating R-CMC544 (given on day 1) and R-GEMOX (given on day 29 and 43).

Being tested
Rituximab, CMC544, Gemcitabine and Oxaliplatine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Rituximab, CMC544, Gemcitabine and OxaliplatineDrug

    2 cycles of induction of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.

    2 cycles of consolidation of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.

Study groups in NCT01562990
Study groupRoleWhat they receive
R-CMC544 and R-GEMOXExperimentalTreatment with R-CMC544 and R-GEMOX
Receives: Drug: Rituximab, CMC544, Gemcitabine and Oxaliplatine

What is being measured

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

  1. Determination of the Recommended Dose of R-CMC544

    Determination of recommended dose will be based on safety parameters and particularly on incidence of DLTs

    Measured: Up to 16 weeks

Secondary outcomes (5)

  1. OVERALL RESPONSE RATE

    Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999 and 2007). Patient is defined as a responder if he/she has a complete response (CR) or partial response (PR) at the end of treatment. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during treatment phase even if they were prematurely withdrawn as responder

    Measured: Up to 32 weeks

  2. PROGRESSION-FREE SURVIVAL

    Progression-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

    Measured: Up to 3.5 years

  3. EVENT FREE SURVIVAL

    Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

    Measured: Up to 3.5 years

  4. OVERALL SURVIVAL

    Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients who are alive at the time of analysis will be censored at the date of the last contact.

    Measured: Up to 3.5 years

  5. COMPLETE RESPONSE RATE

    Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 2007)).

    Patient without response assessment (due to whatever reason) will be considered as nonresponder.

    Measured: 30 or 32 weeks (depending on induction cycle length)

Timeline

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

  1. First posted26 Mar 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionAug 2014
  4. Study completionMar 2016

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01562990
Sponsor's protocol ID
CMC-R-GEMOX
Other IDs
2011-003849-18
Status last verified
May 2016
First submitted
20 Mar 2012
Last updated
23 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rituximab, CMC544, Gemcitabine and Oxaliplatine in people with Diffuse Large B-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 11 sites in 2 countries.

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 9 inclusion and 21 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Belgium. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Determination of the Recommended Dose of R-CMC544 (time frame: Up to 16 weeks). 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 NCT01562990.

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 23 May 2016.

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