NCT01535924

Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Beth Christian · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	Given IV
DRUG	bendamustine hydrochloride	Given IV

Timeline

• Start date: 2012-02-09
• Primary completion: 2019-02-20
• Completion: 2019-02-20
• First posted: 2012-02-20
• Last updated: 2021-11-19
• Results posted: 2021-11-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study