Status:
COMPLETED
Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Cephalon
Conditions:
Hodgkin's Disease
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The standard treatment for patients with HL that has not responded to treatment or has come back after treatment is stem cell transplant. When patients are not eligible for transplant or when HL comes...
Eligibility Criteria
Inclusion
- Histologic diagnosis of Classical Hodgkin lymphoma, confirmed by the department of hematopathology at MSKCC. Patients who have relapsed after an autologous stem cell transplant must have a biopsy after transplant to confirm relapsed Hodgkin's disease. Patients who have relapsed after an allogeneic transplant must also have a biopsy posttransplant.
- Age \> or = to 18
- All patients must have PET avid measurable disease.
- Last chemotherapy \> or = to 4 weeks from the start of Bendamustine HCl
- Receiving no other treatment for HL
- Patients must have normal baseline cardiac function based upon echocardiogram or gated blood pool scan (MUGA) with an ejection fraction \> or = to 50%
- Patients must have a serum creatinine of \< or = to 1.5 mg/dl; if creatinine \>1.5 mg/dl creatinine clearance must be \>60 ml/minute.
- Patients must have ANC\>1000/mcl and Platelets\>100,000/mcl.
- Patients must have a bilirubin level of \< 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
- Patients must be Hepatitis B surface antigen and Hepatitis B core antibody negative and Hepatitis C negative.
- Patients must have failed an autologous stem cell transplant or be ineligible for an autologous stem cell transplant due to chemo-refractory disease(as defined as \<50% response to standard salvage chemotherapy).
- Women who are pre-menopausal must have a negative pregnancy test
- Subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy.
- Patients must be HIV negative.
- 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 enrollment.
- Patients or their guardians must be capable of providing informed consent.
Exclusion
- Patients with either parenchymal brain or lepto-meningeal involvement.
- 7 or more consecutive days of prednisone therapy prior to therapy.
- Known pregnancy or breast-feeding.
- Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude administration of chemotherapy safely. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis
- History of any malignancy for which the disease-free interval is \<5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix.
- Relapse \<6 months post allogeneic stem cell transplant
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00705250
Start Date
June 1 2008
End Date
December 1 2015
Last Update
March 3 2017
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065