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Lymphoma, Mantle-CellPhase 1/2NCT01221103

Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)

A Phase 1/2 study testing Combination of dexamethasone, ofatumumab and bendamustine in people with Lymphoma, Mantle-Cell, run by Southern Europe New Drug Organization at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The rationale for this study design is based on the fact that the maximum tolerated dose (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice of the doses for the combination is based on the investigators unpublished clinical experience, as well as inferred from extensive… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Lymphoma, Mantle-Cell
What is being tested?
Combination of dexamethasone, ofatumumab and bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesItaly
Study dates
Apr 2010to Jun 2012
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60 years.
  • ECOG Performance Status 0-1.
  • Life expectancy of at least 6 months.
  • Histological diagnosis of MCL (morphology, CD5+/CD20+ /CD23-, t(11:14) and/or cyclin D1 overexpression).
  • Disease requiring treatment (patients with bone marrow only disease, who are candidates for a watch-and-wait approach, will be excluded)
  • Adequate bone marrow, liver and renal function, unless the abnormality is related to the tumor and is unlikely to affect the safety of bendamustine and ofatumumab use. Adequate marrow and organ function will be assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
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  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1000/µl
  • Platelet count ≥ 75000/µl
  • Total bilirubin ≤ 1.5 times the ULN
  • AST and ALT ≤ 2.5 x ULN
  • Alkaline phosphatase ≤ 4 x ULN
  • Serum creatinine ≤ 2.5 x ULN
  • PT-INR/PTT < 1.5 x ULN [Patients who are being therapeutically anticoagulated with agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists]
  • Written informed consent.

Who cannot join

  • Previous treatment for mantle-cell lymphoma (MCL)
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
  • Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
  • History of significant cerebrovascular disease or event with significant symptoms or sequelae
  • Glucocorticoid use, unless given in doses ≤ 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than CLL (e.g., asthma)
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  • Known HIV positive
  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the subject will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.
  • Positive serology for hepatitis C (HC) defined by positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer or currently participating in any other interventional clinical study
  • Known or suspected inability to comply with study protocol
  • History of organ allograft
  • Patients with evidence or history of bleeding diathesis.
  • Patients undergoing renal dialysis.
  • Substance abuse, medical psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Trial locations and contacts

2 sites in 1 country.

Michele Magni, MD contact

michele.magni@istitutotumori.mi.it

Italy2 sites, 2 recruiting

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133

    Magni Michele, MD, michele.magni@istitutotumori.mi.it

    Alessandro M. Gianni, MD

    Recruiting

  • Ospedali Bianchi - Melacrino - Morelli

    Reggio Calabria, 89100

    Caterina Stelitano, MD

    Caterina Stelitano, MD

    Recruiting

Other trials in Italy

About this study

Official title: Phase I/II Trial of Dexamethasone, Ofatumumab and Bendamustine [Treanda] (DOT) as First-line Treatment of Mantle-cell Lymphoma (MCL) in the Elderly

The rationale for this study design is based on the fact that the maximum tolerated dose (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice of the doses for the combination is based on the investigators unpublished clinical experience, as well as inferred from extensive experimental data on the use of other monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of the 2 main component drugs is the MTD of each drug as single agent.

Being tested
Combination of dexamethasone, ofatumumab and bendamustine
Keywords
Dexamethasone, Ofatumumab, Bendamustine, Lymphoma, Mantle-Cell, Non-Hodgkin lymphoma
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.

  • Combination of dexamethasone, ofatumumab and bendamustineDrug

    Also called Ofatumumab (HuMax-CD20; ARZERRA), Bendamustine (Treanda; Ribomustin)

    • Ofatumumab (liquid concentrate for infusion in glass vials) infused iv on day 1 at 300 mg during the first cycle, followed by infusions of 1000 mg on day 1 of each subsequent cycle
    • Bendamustine (powder dissolved in sterile water) infused iv over 30-60 minutes at the dose of 120 mg/m2 (days 2,3 every 21 days) or 120 mg/m2(days 2,3 every 28) or 90 mg/m2 (days 2,3 every 28 days) depending on toxicity
    • Dexamethasone administered i.v. at 40 mg (days 1,2,3,4)
Study groups in NCT01221103
Study groupRoleWhat they receive
DOTExperimentalCombination of dexamethasone, ofatumumab and bendamustine
Receives: Drug: Combination of dexamethasone, ofatumumab and bendamustine

What is being measured

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

  1. Adverse events (Phase I)

    Incidence, severity, and attribution of treatment-emergent AEs

    Measured: 60 days after last dose of investigational drug

  2. Complete Response rate (Phase II)

    Response determined according to the revised response criteria for malignant lymphoma (Cheson, JCO 2008)

    Measured: 24 months

Secondary outcomes (6)

  1. Duration of response (Phase II)

    Duration estimated from the first confirmed tumor regression to the disease progression.

    Measured: At the screening, cycle 4 (12 weeks) , cycle 6 (18 weeks), 1 year Follow-up

  2. Serial peripheral blood CD34+ cell counts

    Measured: Cycles 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks)

  3. Molecular analysis of CD34+ cells

    Measured: cycle 4 (12 weeks) or cycle 6 (18 weeks for inadequate harvests after cycle 4)

  4. Serial molecular analysis of peripheral blood cells

    Serial molecular analysis by PCR

    Measured: Cycles 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks)

  5. Ability to harvest ≥ 7 x106 CD34+ cells/kg

    Measured: Cycle 4 (12 weeks) or cycle 6 (18 weeks for inadequate harvests after cycle 4)

  6. Presence of tumor cells in the peripheral blood

    Monitored by morphology, immunophenotype and PCR

    Measured: Cycle 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks)

Timeline

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

  1. First posted14 Oct 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2012 (estimated)
  4. Study completionJun 2012 (estimated)

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221103
Sponsor's protocol ID
INT5909
Status last verified
Sep 2011
First submitted
13 Oct 2010
Last updated
13 Sep 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Combination of dexamethasone, ofatumumab and bendamustine in people with Lymphoma, Mantle-Cell, run by Southern Europe New Drug Organization at 2 sites in Italy.

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 15 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: status not confirmed, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michele Magni, MD (michele.magni@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (Phase I) (time frame: 60 days after last dose of investigational drug). The study lists 2 primary outcomes in all. 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 NCT01221103.

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 13 Sep 2011.

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