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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Recurrent Adult Hodgkin Lymphoma

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Trial Information

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

Inclusion Criteria:

- 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

- 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.

Exclusion Criteria:

- 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)

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Antonio Pinto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematology Oncology and Stem Cell Transplantation Unit , IRCCS Fondazione "G.Pascale" - Naples, Italy


Italy: The Italian Medicines Agency

Study ID:




Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Recurrent Adult Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Lenalidomide
  • Bendamustine
  • Salvage therapy
  • Palliation
  • Hodgkin Disease
  • Lymphoma