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A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma



- Assess the response rate (complete response/remission, unconfirmed complete response,
partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma
treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine


- Assess progression-free survival, failure-free survival, and overall survival of
patients treated with this regimen.

- Characterize the safety profile of this regimen in these patients.

- Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in
patients eligible for stem cell transplantation.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem
cell transplantation (SCT).

- Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV
over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and
pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3
courses in the absence of disease progression or unacceptable toxicity. Patients with
complete response (CR) or partial response (PR) undergo SCT.

- Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate,
gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or
stable disease after 3 courses continue to receive therapy in the absence of disease
progression or unacceptable toxicity.

After completion of study therapy, patients are followed for at least 2 years.

Inclusion Criteria


- Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following
cell types:

- Nodular sclerosis

- Mixed cellularity

- Lymphocyte-rich

- Lymphocyte-depleted

- Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally
measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan

- Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy

- No known CNS metastasis


- ECOG performance status 0-1

- ANC > 1,500/mm^3

- Platelet count > 75,000/mm^3

- Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)

- AST or ALT ≤ 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active hepatitis B infection

- No known chronic hepatitis B carrier

- No HIV positivity

- No concurrent uncontrolled illness including, but not limited to, any of the

- Symptomatic neurological illness

- Active uncontrolled systemic infection considered opportunistic,
life-threatening, or clinically significant at the time of study treatment

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Significant pulmonary disease or hypoxia

- Psychiatric illness or social situation that would limit compliance with study


- See Disease Characteristics

- More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or
investigational therapy and recovered

- No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab

- No other concurrent investigational or commercial agents or therapies with the intent
to treat the malignancy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response, unconfirmed complete response, partial response)

Outcome Time Frame:

After first 3 cycles of treatment

Safety Issue:


Principal Investigator

Alexandra Stefanovic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

October 2012

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • adult lymphocyte depletion Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • adult mixed cellularity Hodgkin lymphoma
  • adult nodular sclerosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136