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