A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 6 - Any |
Updated: | 4/21/2016 |
Start Date: | July 2009 |
End Date: | March 2013 |
Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment
with brentuximab vedotin (SGN-35) in patients who have previously participated in an
brentuximab vedotin study.
with brentuximab vedotin (SGN-35) in patients who have previously participated in an
brentuximab vedotin study.
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin
(SGN-35) treatment in patients who previously participated in a brentuximab vedotin study,
including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008
(NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if
eligible. The study consisted of 2 arms, as follows:
- Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a
complete remission (CR) or partial remission (PR) with previous brentuximab vedotin
treatment on a clinical study and subsequently experienced disease progression or
relapse. The purpose of this arm was to assess safety and efficacy of retreatment with
brentuximab vedotin.
- Extension treatment arm: Patients with either CD30-positive hematologic or
nonhematologic malignancies who completed treatment in a prior brentuximab vedotin
study without unacceptable toxicity and experienced clinical benefit as assessed by the
investigator. The purpose of this arm was to enable patients who participated in
certain prior brentuximab vedotin trials to receive extension treatment and to assess
patient safety and survival in the extension treatment setting.
(SGN-35) treatment in patients who previously participated in a brentuximab vedotin study,
including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008
(NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if
eligible. The study consisted of 2 arms, as follows:
- Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a
complete remission (CR) or partial remission (PR) with previous brentuximab vedotin
treatment on a clinical study and subsequently experienced disease progression or
relapse. The purpose of this arm was to assess safety and efficacy of retreatment with
brentuximab vedotin.
- Extension treatment arm: Patients with either CD30-positive hematologic or
nonhematologic malignancies who completed treatment in a prior brentuximab vedotin
study without unacceptable toxicity and experienced clinical benefit as assessed by the
investigator. The purpose of this arm was to enable patients who participated in
certain prior brentuximab vedotin trials to receive extension treatment and to assess
patient safety and survival in the extension treatment setting.
Inclusion Criteria:
- Participated in a previous brentuximab vedotin study.
- CD30-positive hematologic malignancy.
- At a minimum, experienced clinical benefit in the prior brentuximab vedotin study.
For retreatment, patients must have previously achieved either complete or partial
remission with brentuximab vedotin and experienced disease progression after
discontinuing the prior brentuximab vedotin study.
Exclusion Criteria:
Withdrew consent to participate in any prior brentuximab vedotin study.
We found this trial at
17
sites
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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92 2nd St
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Miami, Florida 33136
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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