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A Phase II Study of Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma.

Phase 2
18 Years
Open (Enrolling)
Hodgkin's Disease, Lymphoma

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Trial Information

A Phase II Study of Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma.

Inclusion Criteria:

- 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

- 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 Criteria:

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Determine the overall response rate (RR) to bendamustine HCL in patients with relapsed and primary refractory HL.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Craig Moskowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

June 2013

Related Keywords:

  • Hodgkin's Disease
  • Lymphoma
  • Bendamustine HCL
  • Hodgkin Disease
  • Lymphoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021