Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL) (SGN+Benda)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01657331 |
Recruitment Status :
Completed
First Posted : August 6, 2012
Last Update Posted : July 17, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hodgkin Lymphoma Anaplastic Large Cell Lymphoma | Drug: Brentuximab Vedotin Drug: Bendamustine Drug: Neulasta | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Clinical Trial of the Combination of Brentuximab Vedotin and Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma |
Actual Study Start Date : | July 2012 |
Actual Primary Completion Date : | April 2020 |
Actual Study Completion Date : | April 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Brentuximab Vedotin / Bendamustine
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive Brentuximab Vedotin in combination with Bendamustine, and prophylactic Neulasta
|
Drug: Brentuximab Vedotin
Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Other Names:
Drug: Bendamustine Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
Other Names:
Drug: Neulasta (Non-experimental) Standard procedure prophylactic pegfilgrastim on day 3 of any subsequent cycle after cycle 1, or filgrastim for 5 to 10 days, per investigator's discretion.
Other Name: pegfilgrastim |
- Maximum tolerated dose (MTD) of brentuximab vedotin and bendamustine (phase 1) [ Time Frame: Up to 1.5 years ]The highest dose that does not cause unacceptable side effects.
- Dose limiting toxicities (DLT) of brentuximab vedotin and bendamustine (phase 1) [ Time Frame: Up to 1.5 years ]A toxicity that prevents further administration of the agent at that dose level.
- Overall Response Rate for the combination of brentuximab vedotin and bendamustine (phase 2) [ Time Frame: Up to 3 years ]The percentage of subjects whose cancer shrinks or disappears after study treatment - Complete Response and Partial Response.
- Duration of Response (DoR) (phase 1) [ Time Frame: Up to 3 years ]Time from documentation of tumor response to disease progression.
- Progression free survival (PFS) (phase 1) [ Time Frame: Up to 3 years ]The length of time during and after the study treatment that a subject lives with the disease but it does not get worse.
- Overall Survival (OS) (phase 2) [ Time Frame: Up to 3 years ]The length of time from either the date of diagnosis or the start of study treatment that subjects diagnosed with the disease are still alive.
- Serum Tarc levels [ Time Frame: Up to 3 years ]This is designed to measure the response to study treatment if the level declines.
- Level of peripheral blood lymphocyte expression of programmed death-1 (PD-1) [ Time Frame: Up to 3 years ]The level will be evaluated as a function of response to therapy with brentuximab vedotin and bendamsutine.
- Decline in serum levels of IL-10 and IL-6 [ Time Frame: Up to 3 years ]The decline will be evaluated as a function of response to therapy with brentuximab vedotin and bendamsutine.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed relapsed or refractory HL or ALCL.
- Documented CD30+ expression from either original diagnosis or a tumor biopsy in the relapsed setting.
- For patients with HL, subjects are eligible after failure or having declined autologous stem cell transplant or at least two prior multi-agent chemotherapy regimens if they are not autologous stem cell transplant candidates. For patients with ALCL, subjects are eligible after failure of at least one prior multi-agent chemotherapy regimen and if they are not eligible for or have declined autologous stem cell transplant.
- Must have received first line chemotherapy. No upper limit for the number of prior therapies.
- Patients with prior autologous or allogeneic stem cell transplant are eligible as long as they meet all other criteria.
- Measurable or evaluable disease, as defined in 2008 Revised Response Criteria for Malignant Lymphoma(33)
- Age > or = 18 years
- ECOG performance status 0,1 or 2
-
Patient's must have adequate organ and marrow function as defined below
- Absolute neutrophil count > or = 1,000 (1.0 x 109/L)
- Platelets > or = 50,000 (50 x 109/L)
- Total Bilirubin < or = 1.5 x institutional limits unless documented Gilbert's syndrome (then < 2.5 x institutional upper limit)
- AST (SGOT)/ALT (SGPT) < or = 2.0 x institutional upper limit of normal (unless known hepatic involvement then < 3.5 x institutional upper limit)
- Creatinine within normal institutional limits OR creatinine clearance > or = 50mL/min for patients with creatinine levels above institutional normal
- If female of childbearing age, negative serum pregnancy test within 7 days prior to the first dose of brentuximab vedotin in this study
- Must be willing to use contraception during the study, and for 30 days following the last dose of study drug.
- Able to understand and to sign a written consent document
Exclusion Criteria:
- Prior treatment with brentuximab vedotin and bendamustine in combination. May have received prior therapy with brentuximab vedotin or bendamustine separately.
- Received either brentuximab vedotin or bendamustine within 3 months of receiving their first dose of protocol based therapy.
- If brentuximab vedotin or bendamustine was previously received, had disease progression during the first 3 cycles of either brentuximab vedotin or bendamustine.
- Systemic steroids that have not been stabilized to the equivalent of < 10 mg/day of prednisone 7 days prior to the initiation of the trial.
- ANY concurrent investigational agents.
- Exposure to chemotherapy, radiotherapy, biologics or investigational agents within 3 weeks prior enrollment in the study.
- Known cerebral or meningeal disease.
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy the patients must be disease free and off treatment for > or = 3 years.
- Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, systemic congestive heart failure Class III or IV by NYHA criteria, unstable angina pectoris, or cardiac arrhythmia, or in patients status post allogeneic transplantation with uncontrolled graft versus host disease (GVHD).
- Pre-existing neuropathy grade III or greater.
- Pregnant or nursing.
- Known hypersensitivity to brentuximab vedotin, bendamustine, or mannitol.
- Known Human Immunodeficiency Virus (HIV) positive, or hepatitis A, hepatitis B or hepatitis C; if hepatitis Bsurface antigen positive or Bcore antibody positive must have normal liver function tests and be willing and able to take anti-hepatitis medication such as lamivudine or equivalent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657331
United States, New York | |
Center for Lymphoid Malignancies at CUMC | |
New York, New York, United States, 10010 | |
Canada, British Columbia | |
British Columbia Cancer Agency | |
Vancouver, British Columbia, Canada, V5z 4E6 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada |
Principal Investigator: | Owen A O'Connor, MD, Ph.D. | Columbia University |
Responsible Party: | Columbia University |
ClinicalTrials.gov Identifier: | NCT01657331 |
Other Study ID Numbers: |
AAAJ5050 |
First Posted: | August 6, 2012 Key Record Dates |
Last Update Posted: | July 17, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hodgkin Lymphoma Hodgkin Disease Hodgkin's Disease Anaplastic Large Cell Lymphoma |
ALCL SGN+Benda Bendamustine Brentuximab Vedotin |
Lymphoma Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell Bendamustine Hydrochloride Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |