Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL) (SGN+Benda)
|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.
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|