Status:
UNKNOWN
A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine in Relapsed and Primary Refractory Hodgkin Lymphoma
Lead Sponsor:
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Conditions:
Recurrent Adult Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01412307
Start Date
July 1 2011
End Date
July 1 2016
Last Update
August 11 2015
Active Locations (1)
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1
Hematology Oncology and Stem Cell Transplantation Unit , IRCCS Fondazione "G.Pascale"
Naples, Italy, 80131