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A Phase I/II Study Of Gemcitabine And Bendamustine In Patients With Relapsed Or Refractory Hodgkin's Lymphoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

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Trial Information

A Phase I/II Study Of Gemcitabine And Bendamustine In Patients With Relapsed Or Refractory Hodgkin's Lymphoma


I. To evaluate the toxicity and determine the maximum tolerated dose (MTD) of combined
bendamustine (bendamustine hydrochloride) and gemcitabine (gemcitabine hydrochloride) in
patients with relapsed or refractory Hodgkin's lymphoma.

II. To determine the overall response rate of bendamustine and gemcitabine in patients with
relapsed and refractory Hodgkin's lymphoma.


I. To determine whether therapy with bendamustine in the setting of relapsed or refractory
Hodgkin's lymphoma will impact future stem cell collection.

OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by
a phase II study.

Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and
bendamustine hydrochloride IV over 30 minutes on days 1 and 2. Treatment repeats every 21-28
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 2 years,
then every 6 months for up to 3 years.

Inclusion Criteria:

- Histologically documented Classical Hodgkin's lymphoma that is recurrent or
refractory after standard chemotherapy; core biopsies are acceptable if they contain
adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as
the sole means of diagnosis are not acceptable

- Patients with Hodgkin's lymphoma may have one of the following World Health
Organization subtypes:

- Nodular sclerosis Hodgkin's lymphoma

- Lymphocyte-rich Hodgkin's lymphoma

- Mixed cellularity Hodgkin's lymphoma

- Lymphocyte depletion Hodgkin's lymphoma

- Nodular lymphocyte predominant Hodgkin's lymphoma

- Patients must have relapsed or progressed after at least one prior therapy

- Patients with relapsed or refractory disease following stem cell transplantation are

- No prior treatment with bendamustine; prior therapy with gemcitabine is permitted

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

- Measurable disease must be present either on physical examination or imaging studies;
non-measurable disease alone is not acceptable

- Measurable disease: lesions that can be accurately measured in at least two
dimensions as >= 1.0 x 1.0 cm by computerized tomography (CT), PET/CT (positron
emission tomography/CT), or magnetic resonance imaging (MRI)

- Non-measurable disease: all other lesions, including small lesions (less than 1.0 x
1.0 cm) and truly non-measurable lesions; lesions that are considered non-measurable
include the following:

- Bone lesions (lesions if present should be noted)

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow (involvement by Hodgkin's lymphoma should be noted)

- Non-pregnant and non-nursing; due to the teratogenic potential of these agents,
pregnant or nursing patients may not be enrolled; women and men of reproductive
potential should agree to use an effective means of birth control

- Patients with human immunodeficiency virus (HIV) infection are eligible; patients
with HIV infection must meet the following: No evidence of co-infection with
hepatitis B or C; cluster of differentiation (CD)4+ count >= 400/mm; no evidence of
resistant strains of HIV; on anti-HIV therapy with an HIV viral load < 50 copies HIV
ribonucleic acid (RNA)/mL; no history of acquired immune deficiency syndrome (AIDS)
defining conditions

- Granulocytes >= 1000/μl

- Platelet count >= 75,000/μl

- Creatinine =< 20 mg/dL

- Bilirubin =< 2.0 mg/dL

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper
limits of normal

Type of Study:


Study Design:

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

Outcome Measure:

Adverse events in terms of dose-limiting toxicity (DLT) and MTD of bendamustine hydrochloride (Phase I)

Outcome Description:

Determined using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate.

Outcome Time Frame:

up to 5 years

Safety Issue:


Principal Investigator

Kristie Blum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Adult Lymphocyte Depletion Hodgkin Lymphoma
  • Adult Lymphocyte Predominant Hodgkin Lymphoma
  • Adult Mixed Cellularity Hodgkin Lymphoma
  • Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
  • Adult Nodular Sclerosis Hodgkin Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Hodgkin's Lymphoma
  • relapsed
  • refractory
  • Hodgkin Disease
  • Lymphoma
  • Sclerosis



Ohio State University Medical Center Columbus, Ohio  43210