Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL) (SGN+Benda)
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|ClinicalTrials.gov Identifier: NCT01657331|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : April 9, 2018
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||April 2019|
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.
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|
|Columbia University Medical Center|
|New York, New York, United States, 10019|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5z 4E6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada|
|Principal Investigator:||Owen A O'Connor, MD, Ph.D.||Columbia University|