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A Phase II Study of Brentuximab Vedotin as Salvage Therapy for Hodgkin Lymphoma Prior to Autologous Hematopoietic Stem Cell Transplantation

Phase 2
19 Years
Open (Enrolling)
Recurrent Adult Hodgkin Lymphoma

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Trial Information

A Phase II Study of Brentuximab Vedotin as Salvage Therapy for Hodgkin Lymphoma Prior to Autologous Hematopoietic Stem Cell Transplantation


I. The primary objective of this study is to determine the activity of salvage brentuximab
vedotin in Hodgkin lymphoma prior to autologous hematopoietic stem cell transplantation, as
measured by overall response rate (ORR).


I. To describe the safety, toxicity, and tolerability of brentuximab vedotin as a salvage

II. To summarize the stem cell mobilization results of patients receiving brentuximab
vedotin as salvage therapy (e.g., total cluster of differentiation (CD)34+ cell yield,
number of apheresis days, proportion of patients who achieve >= 3 x 10^6 CD34+ cells/kg).

III. To evaluate potential changes in Hodgkin lymphoma biological markers of patients
treated with brentuximab vedotin.


Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment
repeats every 21 days for up to 4 courses.

After completion of study treatment, patients are followed up at 21 days.

Inclusion Criteria:

- Patients must have histologically documented or cytologically confirmed Hodgkin
lymphoma with CD 30 expression

- Patients must have absolute neutrophil count (ANC) >= 1000/uL and platelets (Plts) >=
50,000/uL; neupogen can be given prior to start of SGN-35 (brentuximab vedotin) and
during SGN-35 treatment to achieve target ANC >= 1000/uL; platelet transfusion can
also be given prior to the start of SGN-35 and during SGN-35 treatment to achieve a
target plt >= 50,000/uL

- Patients must have measurable disease > 1.5 cm evidenced by computed tomography (CT)
scan of the neck/chest/abdomen(abd)/pelvis or CT/positron emission tomography (PET)

- Patient must be either primary refractory to one frontline induction therapy or
relapsed after one frontline induction therapy; patients who do not achieve complete
remission after induction therapy are also eligible

- Patients cannot have had a second line salvage treatment (chemotherapy, biologic
agents, investigational drugs, or radiation) or have had an autologous or allogeneic
hematopoietic stem cell transplantation; patients can have had mixed frontline
therapy such as 2-4 cycles of ABVD followed by 2-4 cycles of BEACOPP as long as the
induction chemotherapy is not more tha 8 cycles in total length.

- Radiation use as part of induction regimen or consolidation (within 90 days after
completion of induction chemotherapy) is allowed

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study

- Male subject agrees to use an acceptable method of contraception for the duration of
the study

- Life expectancy of greater than 3 months

- Karnofsky performance status of > 60%

- ANC >= 1000/uL

- Plts >= 50,000/uL

- Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits,
patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 X institutional
ULN (unless demonstrated Hodgkin lymphoma involvement of the liver)

- Creatinine up to and including 2 mg/dL (unless demonstrated Hodgkin lymphoma
involvement of the kidney)

Exclusion Criteria:

- Patient has > 1.5 x ULN total bilirubin, unless history of Gilbert's syndrome

- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities; prior to study entry, any
electrocardiogram (ECG) abnormality at screening has to be documented by the
investigator as not medically relevant

- Patient has hypersensitivity to brentuximab vedotin or has had any prior anti-CD 30
antibody treatment

- Female subject is pregnant or breast-feeding; confirmation that the subject is not
pregnant must be established by a negative serum beta-human chorionic gonadotropin
(beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not
required for post-menopausal or surgically sterilized women

- Patient has received other investigational drugs within 14 days before treatment of
treatment with brentuximab vedotin

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study

- Diagnosed or treated for another malignancy within 3 years of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy

- Patients with other active malignancies (no evidence of other cancer or life
expectancy greater than 5 years) are ineligible for this study

- Patients with active central nervous system (CNS) disease or history of brain
metastases (mets) are excluded from study

- Non concurrent use of prednisone > 20 mg

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy of this salvage brentuximab vedotin treatment for Hodgkin lymphoma before autologous hematopoietic stem cell transplantation

Outcome Description:

Measured by the overall response rate (ORR). The study will utilize a Simon two-stage optimal design. Response rates will be calculated as the percent of evaluable patients that have confirmed complete response (CR) or partial response (PR) by radiographic response including CT and/or PET scans, and exact 95% confidence intervals will be calculated for this estimate. Time to response, duration of response, and survival will be estimated using the product-limit method of Kaplan and Meier.

Outcome Time Frame:

21 days after completion of last course of study treatment

Safety Issue:


Principal Investigator

Robert Chen

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Recurrent Adult Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma



City of Hope Medical Center Duarte, California  91010
Weill Medical College, Cornell University New York, New York  10021