NCT01535924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

February 9, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

October 1, 2021

Enrollment Period

7 years

First QC Date

February 6, 2012

Results QC Date

January 19, 2021

Last Update Submit

October 21, 2021

Conditions

Adult Lymphocyte Depletion Hodgkin LymphomaAdult Lymphocyte Predominant Hodgkin LymphomaAdult Mixed Cellularity Hodgkin LymphomaAdult Nodular Lymphocyte Predominant Hodgkin LymphomaAdult Nodular Sclerosis Hodgkin LymphomaRecurrent Adult Hodgkin Lymphoma

Keywords

Hodgkin's Lymphomarelapsedrefractory

Outcome Measures

Primary Outcomes (1)

  • Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I)

    Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting\> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay\>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours.

    up to 5 years

Secondary Outcomes (1)

  • Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II)

    up to 5 years

Study Arms (1)

Treatment (combination chemotherapy)

EXPERIMENTAL

Patients receive gemcitabine hydrochloride 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.

Drug: gemcitabine hydrochlorideDrug: bendamustine hydrochloride

Interventions

gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (combination chemotherapy)
bendamustine hydrochlorideDRUG

Given IV

Also known as: bendamustin hydrochloride, bendamustine, cytostasan hydrochloride, Treanda
Treatment (combination chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 permitted
  • 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)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Cohen JB, Wei L, Maddocks KJ, Christian B, Heffner LT, Langston AA, Lechowicz MJ, Porcu P, Flowers CR, Devine SM, Blum KA. Gemcitabine and bendamustine is a safe and effective salvage regimen for patients with recurrent/refractory Hodgkin lymphoma: Results of a phase 1/2 study. Cancer. 2020 Mar 15;126(6):1235-1242. doi: 10.1002/cncr.32640. Epub 2019 Dec 10.

    PMID: 31821549BACKGROUND

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseRecurrence

Interventions

GemcitabineBendamustine Hydrochloride

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Beth Christian
Organization
The Ohio State University
Beth.Christian@osumc.edu
614-293-7807

Study Officials

  • Beth Christian, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 20, 2012

Study Start

February 9, 2012

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

November 19, 2021

Results First Posted

November 19, 2021

Record last verified: 2021-10

Locations

US(2)