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Recurrent Adult Hodgkin LymphomaPhase 1/2LEBENNCT01412307

A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine in Relapsed and Primary Refractory Hodgkin Lymphoma

A Phase 1/2 study testing Lenalidomide, Bendamustine and Bio-specimen Retention in people with Recurrent Adult Hodgkin Lymphoma, run by Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation failure represents a typical unmet medical need prompting active development and validation of new agents and treatment strategies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Adult Hodgkin Lymphoma
What is being tested?
Lenalidomide, Bendamustine and Bio-specimen Retention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteItaly
Study dates
Jul 2011to Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed classical Hodgkin lymphoma (HL).
  • Patients must have failed an autologous stem cell transplant or be ineligible for high-dose therapy due to chemorefractory disease (as defined as <50% response to standard salvage chemotherapy), age or comorbidity.
  • Patients must have at least one target PET-avid bidimensionally measurable lesion,
  • Age >18 years
  • Life expectancy of greater than 3 months
  • ECOG performance status <2
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  • Patients must have adequate organ and marrow function as defined below: absolute neutrophil count >1,000/mL; platelets >75,000/mL; total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's disease); however dose reduction is recommended for Bendamustine in patients with 30 - 70 % tumour involvement of the liver and moderately diminished liver function (serum bilirubin 1.2 - 3.0 mg/dl); AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal; creatinine within normal institutional limits OR creatinine clearance >50 mL/min/1.73 m2
  • Patients must have echocardiogram or gated blood pool scan (MUGA) with an ejection fraction > or = to 50%
  • If patients have a history of malignancy other than cutaneous basal cell or squamous cell carcinoma, they must be disease-free for ~ 5 years at the time of enrolment
  • Patients must accept contraception measures until 4 weeks after the completion of chemotherapy, and up to 6 months for male patients.
  • Women of child-bearing must have a medically supervised negative pregnancy test even if had been using effective contraception.
  • Patients agree not to share study medication with another person and to return all unused study drug to the investigator
  • Patients or their guardians must be capable to understand and must be willing to sign a written informed consent document.

Who cannot join

  • Treatment with chemotherapy or external radiotherapy within 6 weeks, or monoclonal antibodies within 8 weeks or radioimmunoconjugates in the previous 12 weeks prior to entering the study
  • Treatment with any other investigational agent
  • Parenchymal brain or leptomeningeal HL involvement
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study
  • Known HIV positivity or active infectious hepatitis, type A, B, or C
  • Clinically significant cardiac disease (NYHA Class III or IV)
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  • Abnormal QTcF interval prolonged (> 459 msec)
  • Known pregnancy or breastfeeding.
  • Jaundice
  • Yellow fever vaccination
  • Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude safe administration of lenalidomide and bendamustine
  • Corticoid treatment different from low dose prednisone or methylprednisone (up to 16 mg), used for B symptoms control.
  • Contraindications for receiving prophylaxis against deep vein thrombosis
  • Thromboembolic disease grade 3-4 in the last 6 months
  • More than one month between staging procedures and the start of the treatment
  • Major surgical procedures less than 30 days before the start of treatment

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Hematology Oncology and Stem Cell Transplantation Unit , IRCCS Fondazione "G.Pascale"

    Naples, 80131

Other trials in Italy

About this study

Official title: A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine (LEBEN) in Relapsed and Primary Refractory Hodgkin Lymphoma

Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation failure represents a typical unmet medical need prompting active development and validation of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide and bendamustine, framing different targets on both tumor and microenvironmental cells of HL. These agents, while showing a low risk of overlapping extrahematologic toxicities, may hit the proliferation machinery of H-RS cells and/or their progenitors, synergistically inhibit tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating in the microenvironment to support tumor cell survival.

A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a 28-day cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and protracted doses of alkylators induce a decrease in microvascular density of tumor tissues and inhibit mobilization and viability of circulating endothelial progenitors.

The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method chooses doses based-on both response and toxicity, and accounts for the trade-off between these two outcomes.

Being tested
Lenalidomide, Bendamustine, Bio-specimen Retention
Keywords
Hodgkin Lymphoma, Lenalidomide, Bendamustine, Salvage therapy, Palliation
Medical subject headings
Hodgkin Disease

What participants receive

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

  • LenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    10, 15, 20 or 25 mg orally per cohort day 1-28 in a 28 days cycle

  • BendamustineDrug

    Also called SDX-105, Ribomustin, Treanda, Cytostasan

    intravenous on days 1, 8 and 15 of each 28-days cycle at fixed dose of 60 mg/m2, as a 30-60 min i.v. infusion

  • Bio-specimen RetentionOther

    Samples with DNA and without DNA

Study groups in NCT01412307
Study groupRoleWhat they receive
lenalidomide plus bendamustineExperimentalNot described
Receives: Drug: Lenalidomide; Drug: Bendamustine; Other: Bio-specimen Retention

What is being measured

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

  1. Dose finding, as best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook

    According to the Bayesian phase I/II dose finding method of Thall and Cook,a target efficacy-toxicity trade-off contour has been constructed by fitting a curve to target values of pE (probability ofEfficacy) and pT (probability of Toxicity) of 0.30 and 0.40, respectively and probability cut-offs pE (for Efficacy)and pT (for Toxicity) set at 0.10 and 0.10,respectively.The area underneath the target contour has desirable πE, πT pairs. Up to 36 patients can be treated in cohorts of size 3. The 'best' dose is defined as that giving the largest response-toxicity trade-off.

    Measured: Evaluation at day +56, i.g. after two cycles.

Secondary outcomes (5)

  1. AE/SAE rate at completion of treatment

    Measured: After course 6. i.g. about 6 months

  2. Overall Rate Response

    Measured: After 2, 4 and 6 cycles

  3. Event Free Survival

    Measured: From the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason

  4. Time to Progression

    Measured: From entry until documented lymphoma progression or death as a result of lymphoma.

  5. Response Duration

    Measured: From the time when criteria for response (i.g. CR or PR) are met, for which the event is the first documentation of relapse or progression.

Timeline

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

  1. First posted9 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2015
  4. Study completionJul 2016 (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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412307
Sponsor's protocol ID
LEBEN-HL
Other IDs
2011-002810-35
Acronym
LEBEN
Status last verified
Aug 2015
First submitted
3 Aug 2011
Last updated
11 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • http://meetinglibrary.asco.org/content/132091-144

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, Bendamustine and Bio-specimen Retention in people with Recurrent Adult Hodgkin Lymphoma, run by Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale at 1 site 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 13 inclusion and 16 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 11 Aug 2015. 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 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?

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?

Dose finding, as best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook (time frame: Evaluation at day +56, i.g. after two cycles.). 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 NCT01412307, 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 11 Aug 2015.

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