Hodgkin LymphomaPhase 1/2SGN+BendaNCT01657331

Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)

A Phase 1/2 study testing Brentuximab Vedotin, Bendamustine and Neulasta in people with Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma, run by Columbia University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
What is being tested?: Brentuximab Vedotin, Bendamustine and Neulasta
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 3 sitesin 2 countries
Study dates: Jul 2012to Jun 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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

Who cannot join

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.

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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.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Canada2 sites

Princess Margaret Hospital
Toronto, Ontario
British Columbia Cancer Agency
Vancouver, British Columbia, V5z 4E6

Other trials in Canada

United States1 site

Center for Lymphoid Malignancies at CUMC
New York, New York, 10010

Other trials in United States

About this study

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

Read the detailed description

Brentuximab vedotin will be administered as an outpatient IV infusion on day 1 of each 21-day cycle. Bendamustine will be given as an outpatient infusion on days 1 and 2 of a 21-day cycle. Patients may receive prophylactic pegfilgrastim on day 3 of each cycle, or filgrastim for 5 to 10 days, per investigator's discretion. Patients can receive a maximum of 6 cycles of therapy.

Conditions: Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
Being tested: Brentuximab Vedotin, Bendamustine, Neulasta
Keywords: Hodgkin Lymphoma, Hodgkin Disease, Hodgkin's Disease, Anaplastic Large Cell Lymphoma, ALCL, SGN+Benda, Bendamustine, Brentuximab Vedotin
Medical subject headings: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brentuximab VedotinDrug
Also called Adcetris, SGN35
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.
BendamustineDrug
Also called Treanda, Bendamustine HCl
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.
NeulastaDrug
Also called pegfilgrastim
(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.

Study groups in NCT01657331
Study group	Role	What they receive
Brentuximab Vedotin / Bendamustine	Experimental	Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive Brentuximab Vedotin in combination with Bendamustine, and prophylactic Neulasta Receives: Drug: Brentuximab Vedotin; Drug: Bendamustine; Drug: Neulasta

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Measured: 21 days
Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Measured: 21 days
Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1
DLT is defined as any missed dose within cycle 1 or toxicity that was possibly related to the study drug occurring up to 7 days after completion of cycle 1 that resulted in a delay of initiation of cycle 2; grade 4 neutropenia that did not resolve to grade 2 or lower within 7 days; grade 4 thrombocytopenia lasting more than 7 days; grade 3 febrile neutropenia (absolute neutrophil count of <1000 cells per μL with a single temperature of >38·3°C or a sustained temperature of ≥38°C for >1 h); and any grade 3 or worse non-haematological toxicity, with the specific exception of nausea, vomiting, diarrhoea, or dehydration lasting for more than 48 h in the setting of inadequate compliance with supportive care measures or grade 3 hypercholesterolaemia, hypertriglyceridaemia, constipation, or fatigue.
Measured: 21 days
Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine
The number of subjects whose cancer shrinks or disappears after study treatment
Measured: Up to 3 years

Secondary outcomes (3)

Duration of Response (DoR) in Phase 1
Duration of response is defined as the time from documentation of a response to treatment to the first documentation of tumor progression, or death from any cause, whichever occurred first.
Measured: Up to 50 months
Progression Free Survival (PFS) in Phase 1
The length of time during and after the study treatment that a subject lives with the disease but it does not get worse.
Measured: Up to 50 months
Overall Survival (OS) in Phase 1
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.
Measured: Up to 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jun 2018

First posted6 Aug 2012 (estimated)
Study startJul 2012
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01657331
Sponsor's protocol ID: AAAJ5050
Acronym: SGN+Benda
Status last verified: May 2026
First submitted: 2 Aug 2012
Last updated: 24 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

O'Connor OA, Lue JK, Sawas A, Amengual JE, Deng C, Kalac M, Falchi L, Marchi E, Turenne I, Lichtenstein R, Rojas C, Francescone M, Schwartz L, Cheng B, Savage KJ, Villa D, Crump M, Prica A, Kukreti V, Cremers S, Connors JM, Kuruvilla J. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol. 2018 Feb;19(2):257-266. doi: 10.1016/S1470-2045(17)30912-9. Epub 2017 Dec 21.
PubMed 29276022

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hodgkin Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01657331
Acronym / sponsor ID: SGN+Benda / AAAJ5050
Conditions: Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
Keywords: Hodgkin Lymphoma, Hodgkin Disease, Hodgkin's Disease, Anaplastic Large Cell Lymphoma, ALCL, SGN+Benda, Bendamustine, Brentuximab Vedotin
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: Jul 2012 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 6 Aug 2012 (estimated)
Results: Posted 24 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Brentuximab Vedotin / Bendamustine	Experimental	Drug: Brentuximab Vedotin, Drug: Bendamustine, Drug: NeulastaSubjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive Brentuximab Vedotin in combination with Bendamustine, and prophylactic Neulasta

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brentuximab VedotinAlso: Adcetris, SGN35Dose 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.	Drug	Brentuximab Vedotin / Bendamustine
BendamustineAlso: Treanda, Bendamustine HClDose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.	Drug	Brentuximab Vedotin / Bendamustine
NeulastaAlso: pegfilgrastim(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.	Drug	Brentuximab Vedotin / Bendamustine

Primary outcome

Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
Time frame: 21 days
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
Time frame: 21 days
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1
Time frame: 21 days
DLT is defined as any missed dose within cycle 1 or toxicity that was possibly related to the study drug occurring up to 7 days after completion of cycle 1 that resulted in a delay of initiation of cycle 2; grade 4 neutropenia that did not resolve to grade 2 or lower within 7 days; grade 4 thrombocytopenia lasting more than 7 days; grade 3 febrile neutropenia (absolute neutrophil count of <1000 cells per μL with a single temperature of >38·3°C or a sustained temperature of ≥38°C for >1 h); and any grade 3 or worse non-haematological toxicity, with the specific exception of nausea, vomiting, diarrhoea, or dehydration lasting for more than 48 h in the setting of inadequate compliance with supportive care measures or grade 3 hypercholesterolaemia, hypertriglyceridaemia, constipation, or fatigue.
Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine
Time frame: Up to 3 years
The number of subjects whose cancer shrinks or disappears after study treatment

3 secondary outcomes

Duration of Response (DoR) in Phase 1
Time frame: Up to 50 months
Progression Free Survival (PFS) in Phase 1
Time frame: Up to 50 months
Overall Survival (OS) in Phase 1
Time frame: Up to 50 months

Results and safety

Results posted to the registry on 24 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2	7	5
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2	3	3
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2	7	5
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2	11	9
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2	37	33

Primary outcome: Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)

Time frame: 21 days. Number. Unit: mg/kg

Measure	Phase 1 n = 28
Value	1.8

Population analysed: This Outcome Measure is specific to Phase 1 of the study, so only Phase 1 population is reported here.

Primary outcome: Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)

Time frame: 21 days. Number. Unit: mg/m2

Measure	Phase 1 n = 28
Value	90

Population analysed: This Outcome Measure is specific to Phase 1 of the study, so only Phase 1 population is reported here.

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1

Time frame: 21 days. Count of participants. Unit: Participants

Measure	Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2 n = 7	Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2 n = 3	Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2 n = 7	Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 n = 11
Value	1	0	1	1

Primary outcome: Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine

Time frame: Up to 3 years. Count of participants. Unit: Participants

Measure	Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2 n = 6	Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2 n = 3	Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2 n = 7	Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 n = 8	Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2 n = 25
Value	3	3	5	4	21

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2	3 of 7 (42.9%)	7 of 7 (100%)	6 of 7
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2	2 of 7 (28.6%)	7 of 7 (100%)	2 of 7
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2	5 of 11 (45.5%)	11 of 11 (100%)	6 of 11
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2	12 of 37 (32.4%)	35 of 37 (94.6%)	7 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29276022O'Connor OA, Lue JK, Sawas A, Amengual JE, Deng C, Kalac M, Falchi L, Marchi E, Turenne I, Lichtenstein R, Rojas C, Francescone M, Schwartz L, Cheng B, Savage KJ, Villa D, Crump M, Prica A, Kukreti V, Cremers S, Connors JM, Kuruvilla J. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol. 2018 Feb;19(2):257-266. doi: 10.1016/S1470-2045(17)30912-9. Epub 2017 Dec 21.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Owen A O'Connor, MD, Ph.D. principal investigator

Columbia University

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Brentuximab Vedotin, Bendamustine and Neulasta in people with Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma, run by Columbia University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1) (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01657331, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.