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Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Lymphoma

Thank you

Trial Information

Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma


Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the
first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD
on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD
will be given to you by intravenous infusion (IV).

The following test and procedures will be performed on Days 1 and 15 of each cycle:

- Review of any side effects you have experienced and all medications you are taking

- Performance Status

- Physical exam and vital signs

- Routine blood tests

- Questionnaire to evaluate symptoms of neuropathy

- Research blood sample to look at markers to see how your body is responding to study
medication

- PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD

After the final dose of the study drug: The following assessments will be performed within
one month of your last dose of study medication:

- Review of any side effects you have experienced and all medications you are taking

- Performance Status

- Physical exam and vital signs

- Routine blood tests

- Questionnaire to evaluate symptoms of neuropathy

- Research blood sample to look at markers to see how your body is responding to study
medication

- PET-CT scan Follow up will include the following

- Review of any side effects you have experienced and all medications you are taking

- Performance Status

- Review and Physical exam

- Routine blood tests

- Questionnaire to evaluate symptoms of neuropathy

- CT scans


Inclusion Criteria:



- Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma

- Non-bulky disease defined as less than 10 cm in maximal diameter

- Measurable disease greater than or equal to 1.5 cm

- ECOG performance status of 0 or 2

- Willing to use 2 effective forms of birth control

Exclusion Criteria:

- No prior chemotherapy or radiotherapy for Hodgkin lymphoma

- Not receiving any other investigational agents

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab

- No pre-existing grade 3 or greater neuropathy

- No uncontrolled intercurrent illness

- Not pregnant or breastfeeding

- No history of a different malignancy unless disease free for at least one year

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Investigate clinical activity of Brentuximab w/AVD in cHL

Outcome Description:

Primary clinical endpoint is complete remission rate measured by PET/CT. Overall response rate, Failure-free survival and overall survival will also be assessed.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Jeremy Abramson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

11-462

NCT ID:

NCT01534078

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Hodgkin Lymphoma
  • non-bulky
  • limited stage
  • Hodgkin Disease
  • Lymphoma

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Moffitt Cancer CenterTampa, Florida  33612
Massachusetts General HosptialBoston, Massachusetts  02114