Adult Lymphocyte Depletion Hodgkin LymphomaPhase 2NCT00337194
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
A Phase 2 study testing monoclonal antibody SGN-30, vinorelbine tartrate and pegylated liposomal doxorubicin hydrochloride in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Lymphocyte Predominant Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma
- What is being tested?
- monoclonal antibody SGN-30, vinorelbine tartrate and pegylated liposomal doxorubicin hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Oct 2014
- Phase
- Phase 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 documented CD30-positive classical Hodgkin lymphoma according to the World Health Organization (WHO) classification of lymphoid malignancies that is recurrent or refractory after at least one prior therapy
- Note: Patients with nodular lymphocyte predominant HL are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and mixed cellularity HL may be enrolled
- Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable; if the original diagnostic specimen is not available, specimens obtained at relapse may be submitted; if multiple specimens are available, please submit the most recent; failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
- Patients must have relapsed or refractory disease after at least one prior therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen; recovery to =< grade 1 from all toxicities related to the prior treatments is required; patients who have previously received a stem cell transplant are permitted to enroll on this study
- Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated liposomal doxorubicin is not permitted
- No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry, and no New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)
Show all 25Show fewer
- Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must be >= 45%
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease must be present on either physical examination or imaging studies; evaluable or non-measurable disease alone is not acceptable
- Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm
- Non-measurable disease includes all other lesions, including small lesions (< 10 mm) and truly non-measurable lesions
- Lesions that are considered non-measurable include the following:
- Bone lesions (lesions, if present, should be noted)
- Bone marrow involvement (if present, this should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Pregnant or nursing women may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test prior to registration; women and men of reproductive potential should agree to use an effective means of birth control
- Corrected diffusion capacity of carbon monoxide (DLCO) >= 50%
- Absolute neutrophil count (ANC) >= 1,200/uL
- Platelet count >= 100,000/uL
- Creatinine =< 2.0 mg/dL
- Bilirubin =< 2.0 mg/dL
- Absent a history of Gilbert's disease
- Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the complete and partial response rates following treatment with the anti-cluster of differentiation (CD) 30 antibody, SGN-30 (monoclonal antibody SGN-30), and gemcitabine (gemcitabine hydrochloride), vinorelbine (vinorelbine tartrate), and pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) (GVD) in patients with relapsed or refractory Hodgkin lymphoma (HL).
II. To assess time to progression and overall survival in patients treated with SGN-30 and GVD in patients with relapsed or refractory Hodgkin lymphoma (HL).
III. To evaluate the toxicity of SGN-30 in combination with GVD in patients with relapsed and refractory HL.
SECONDARY OBJECTIVES:
- To determine the pharmacokinetic profile of SGN-30 when combined with GVD chemotherapy.
II. To correlate soluble (s) CD30 levels with response to treatment. III. To determine the incidence of human anti-chimeric antibodies (HACA) formation following repetitive SGN-30 dosing.
IV. To correlate Fc gamma receptor polymorphisms with response to treatment.
OUTLINE:
Part 1 (closed to accrual as of 5/18/2007): Patients receive monoclonal antibody SGN-30 intravenously (IV) over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity. Subsequent patients receive treatment on part 2.
Part 2: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8.
Arm II (closed to accrual as of 12/4/07): Patients receive placebo IV over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8.
Treatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: Treatment with SGN-30/placebo was stopped on 4/12/2007 due to pulmonary toxicity.
After completion of study treatment, patients are followed up periodically for up to 10 years.
- Conditions
- Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma
- Being tested
- monoclonal antibody SGN-30, placebo, vinorelbine tartrate, pegylated liposomal doxorubicin hydrochloride, gemcitabine hydrochloride
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monoclonal antibody SGN-30Biological
Also called SGN-30
Given IV
placeboOther
Also called PLCB
Given IV
vinorelbine tartrateDrug
Also called Eunades, navelbine ditartrate, NVB, VNB
Given IV
pegylated liposomal doxorubicin hydrochlorideDrug
Also called CAELYX, Dox-SL, DOXIL, doxorubicin hydrochloride liposome
Given IV
Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SGN-30, chemotherapy) | Experimental | Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m^2 IV days 1 \& 8, gemcitabine: 1000 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m^2 IV days 1 \& 8, gemcitabine: 800 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8. Receives: Biological: monoclonal antibody SGN-30; Drug: vinorelbine tartrate; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study |
| Arm II (placebo, chemotherapy) | Active comparator | Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m^2 IV days 1 \& 8, gemcitabine: 1000 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m^2 IV days 1 \& 8, gemcitabine: 800 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8. Receives: Other: placebo; Drug: vinorelbine tartrate; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Overall Response (OR)
The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions.
Measured: Up to 10 years
Secondary outcomes (2)
Event Free Survival (EFS)
Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Measured: Up to 10 years
Overall Survival (OS) At 1 Year
Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2008
- Study completionOct 2014
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.
- Other trials for Adult Lymphocyte Depletion Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kristie Blum, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337194
- Sponsor's protocol ID
- NCI-2012-02822
- Other IDs
- NCI-2012-02822, CALGB-50502, CALGB-50502, U10CA031946, P30CA014236
- Status last verified
- Oct 2014
- First submitted
- 13 Jun 2006
- Last updated
- 23 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00337194
- Acronym / sponsor ID
- NCI-2012-02822
- Conditions
- Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.
Detailed description
PRIMARY OBJECTIVES:
- To determine the complete and partial response rates following treatment with the anti-cluster of differentiation (CD) 30 antibody, SGN-30 (monoclonal antibody SGN-30), and gemcitabine (gemcitabine hydrochloride), vinorelbine (vinorelbine tartrate), and pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) (GVD) in patients with relapsed or refractory Hodgkin lymphoma (HL).
II. To assess time to progression and overall survival in patients treated with SGN-30 and GVD in patients with relapsed or refractory Hodgkin lymphoma (HL).
III. To evaluate the toxicity of SGN-30 in combination with GVD in patients with relapsed and refractory HL.
SECONDARY OBJECTIVES:
- To determine the pharmacokinetic profile of SGN-30 when combined with GVD chemotherapy.
II. To correlate soluble (s) CD30 levels with response to treatment. III. To determine the incidence of human anti-chimeric antibodies (HACA) formation following repetitive SGN-30 dosing.
IV. To correlate Fc gamma receptor polymorphisms with response to treatment.
OUTLINE:
Part 1 (closed to accrual as of 5/18/2007): Patients receive monoclonal antibody SGN-30 intravenously (IV) over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity. Subsequent patients receive treatment on part 2.
Part 2: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8.
Arm II (closed to accrual as of 12/4/07): Patients receive placebo IV over 2 hours, vinorelbine tartrate IV over 6-10 minutes, gemcitabine hydrochloride IV over 30 minutes, and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8.
Treatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: Treatment with SGN-30/placebo was stopped on 4/12/2007 due to pulmonary toxicity.
After completion of study treatment, patients are followed up periodically for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (SGN-30, chemotherapy) | Experimental | Biological: monoclonal antibody SGN-30, Drug: vinorelbine tartrate, Drug: pegylated liposomal doxorubicin hydrochloride, Drug: gemcitabine hydrochloride, Other: laboratory biomarker analysis, Other: pharmacological studyParticipants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m^2 IV days 1 \& 8, gemcitabine: 1000 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m^2 IV days 1 \& 8, gemcitabine: 800 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8. |
| Arm II (placebo, chemotherapy) | Active comparator | Other: placebo, Drug: vinorelbine tartrate, Drug: pegylated liposomal doxorubicin hydrochloride, Drug: gemcitabine hydrochloride, Other: laboratory biomarker analysis, Other: pharmacological studyParticipants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m^2 IV days 1 \& 8, gemcitabine: 1000 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m^2 IV days 1 \& 8, gemcitabine: 800 mg/m^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically documented CD30-positive classical Hodgkin lymphoma according to the World Health Organization (WHO) classification of lymphoid malignancies that is recurrent or refractory after at least one prior therapy
- Patients must have relapsed or refractory disease after at least one prior therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen; recovery to =< grade 1 from all toxicities related to the prior treatments is required; patients who have previously received a stem cell transplant are permitted to enroll on this study
- No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry, and no New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)
- Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must be >= 45%
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| monoclonal antibody SGN-30Also: SGN-30Given IV | Biological | Arm I (SGN-30, chemotherapy) |
| placeboAlso: PLCBGiven IV | Other | Arm II (placebo, chemotherapy) |
| vinorelbine tartrateAlso: Eunades, navelbine ditartrate, NVB, VNBGiven IV | Drug | Arm I (SGN-30, chemotherapy), Arm II (placebo, chemotherapy) |
| pegylated liposomal doxorubicin hydrochlorideAlso: CAELYX, Dox-SL, DOXIL, doxorubicin hydrochloride liposomeGiven IV | Drug | Arm I (SGN-30, chemotherapy), Arm II (placebo, chemotherapy) |
| gemcitabine hydrochlorideAlso: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, GemzarGiven IV | Drug | Arm I (SGN-30, chemotherapy), Arm II (placebo, chemotherapy) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (SGN-30, chemotherapy), Arm II (placebo, chemotherapy) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (SGN-30, chemotherapy), Arm II (placebo, chemotherapy) |
Primary outcome
Number of Participants With Overall Response (OR)
Time frame: Up to 10 years
The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions.
2 secondary outcomes
Event Free Survival (EFS)
Time frame: Up to 10 years
Overall Survival (OS) At 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Kristie Blum principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing monoclonal antibody SGN-30, vinorelbine tartrate and pegylated liposomal doxorubicin hydrochloride in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Lymphocyte Predominant Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
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 25 inclusion and 0 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 phase mean?
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 23 Feb 2015). 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?
Number of Participants With Overall Response (OR) (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.