Indolent Non-hodgkin LymphomaPhase 2GABe2016NCT03492775
First Line Therapy of Advanced Stage Follicular Lymphoma in Patients < 60 Years Not Eligible fo Standard Immunochemotherapy and in All Patients ≥ 60 Years
A Phase 2 study testing Obinutuzumab and Bendamustine in people with Indolent Non-hodgkin Lymphoma, run by Prof. Dr. Wolfgang Hiddemann at 1 site in Germany.
Trial summary
The objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, 'compromised' patients and in all older patients (≥ 60 years). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Non-hodgkin Lymphoma
- What is being tested?
- Obinutuzumab and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2017to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Medically nonfit" patients < 60 years defined by
- o ECOG > 2 or ECOG 0-2 with co-morbidities excluding intensive therapy according to local investigator's discretion
- All patients ≥ 60 years in case of decision of investigator and patient to apply a reduced Treatment
- Documentation of the CIRS-G, IADL, G8 and ECOG Scores before start of treatment
- Histologically confirmed follicular lymphoma grade I, II or IIIa with material available for central pathology review
- Stage III/IV or stage II without the option of curative radiotherapy
Show all 23Show fewer
- Age > 18 years
- No prior therapy
- Presence of at least one of the following symptoms or conditions requiring initiation of treatment:
- Bulky disease according to the GELF criteria: nodal or extranodal mass > 7cm in its greater diameter
- B symptoms (fever, drenching night sweats, or unintentional weight loss of >10% of normal body weight over a period of 6 months or less)
- Hematopoietic insufficiency (at least one of the following: granulocytopenia <1500 cells/μl, Hb < 10 g/dl, thrombocytopenia <100.000 cells/μl)
- Compressive syndrome
- Pleural/peritoneal effusion
- Symptomatic nodal or extranodal manifestations
- At least one bi-dimensionally measurable lesion (> 1.5 cm in its largest dimension by CT scan or MRI)
- Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:
- hemoglobin ≥ 9.0 g/dl
- absolute neutrophil count ≥ 1500 /μL
- platelet count ≥ 75000 /μl
- Women who are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 18 months thereafter.
- Men who agree not to father a child during participation in the trial and during the 18 months thereafter.
- Written informed consent form
Who cannot join
- "Medically fit" patients < 60 years with the option for more intensive induction therapy such as R-CHOP
- Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma)
- Grade IIIb follicular lymphoma
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).
- Regular use of corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone.
- Prior (< 3 years) or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.
Show all 20Show fewer
- Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
- Necessity of rapid cytoreduction
- Serious underlying medical conditions, which could impair the ability of the patient to tolerate the therapy offered in this trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
- Severe hepatic impairment (serum bilirubin > 3.0 mg/dl)
- Known sensitivity or allergy to murine products
- Known hypersensitivity to any of the study drugs
- Treatment within a clinical lymphoma trial within 30 days prior to trial entry
- Positive test results for chronic HBV infection (defined as positive HBsAg serology) (mandatory testing) Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBSAb) after vaccination or prior but cured hepatitis B are eligible.
- Positive test results for hepatitis C (mandatory hepatitis C virus [HCV] antibody serology testing). Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
- Known history of HIV seropositive status.
- Patients with a history of confirmed PML
- Vaccination with a live vaccine within 28 days prior to registration
- Prior organ, bone marrow or peripheral blood stem cell transplantation
- Any other co-existing medical or psychological condition that will preclude participation in the study or compromise the ability to understand its nature,meaning and implications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Evaluation of Single Agent GA101 Versus GA101 Plus Bendamustine Followed by GA101
The objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, 'compromised' patients and in all older patients (≥ 60 years). For the assessment of the antilymphoma activity the overall response rate (ORR)" will be applied as primary endpoint.
Overall response is defined as complete or partial response after 19 - 21 weeks.
Read the detailed description
Study design:
This is a randomized, open-label, multicenter phase II trial with a parallel-group design of two groups.
Randomization and Interventions:
Randomization between Obinutuzumab single agent treatment versus Obinutuzumab plus Bendamustine followed by Obinutuzumab
Treatment plans:
Arm A: Obinutuzumab single agent Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1
If at least 'stable disease':
Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 Arm B: Obinutuzumab plus Bendamustine Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 plus Bendamustine 70 mg/m2 iv d1+2 of each of four 28 -day cycles
If at least 'stable disease':
Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45
The project attempts to establish an evidence based treatment strategy for medically non-fit advanced stage FL-patients who are not eligible for standard therapeutic immunochemotherapy approaches to improve their long term perspectives.
It will furthermore provide a prospectively generated data set which will link performance in the assessment scores IADL, G8 and CIRS-G to medical fitness as judged by the treating physician. The generated data will allow using geriatric and functional tests to define medical fitness and to provide a more solid basis for future studies.
- Conditions
- Indolent Non-hodgkin Lymphoma
- Being tested
- Obinutuzumab, Bendamustine
- Keywords
- indolent lymphoma, Obinutuzumab, GA101, Bendamustine, medically non-fit patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called GA 101
Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies.
BendamustineDrug
Also called Bendamustine hydrochloride; Ribomustin
Bendamustine belongs formally to the alkylators, but has been shown to have a unique mechanism of action. The dose limiting toxicity of bendamustine is its reversible suppression of bone marrow function with drops in leukocyte and thromobocyte counts.
| Study group | Role | What they receive |
|---|---|---|
| Arm A:Obinutuzumab single agent | Active comparator | Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1
If at least 'stable disease':
Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 Receives: Drug: Obinutuzumab |
| Arm B:Obinutuzumab plus Bendamustine | Active comparator | Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 plus Bendamustine 70 mg/m2 iv d1+2 of each of four 28 -day cycles
If at least 'stable disease':
Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 Receives: Drug: Obinutuzumab; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall response is defined as complete or partial response at the end of the initial treatment phase (after 19-21 weeks).
Measured: week 19 to 21
Secondary outcomes (18)
Event free survival, EFS
Response in accordance with the 2007 Revised Response Criteria for the time from the day of randomization to the date of first documented disease progression, death by any cause, or institution of a new anti-lymphoma treatment.
Measured: through study completion, up to 5 years
CR
Rate of patients who has a complete response (CR) at the end of induction randomization
Measured: End of Induction of each patient, week 19 - 21
TTF
The time to treatment failure will be measured from the day of randomization to the date of failure of initial treatment (no response) or first documented disease progression or death by any cause.
Measured: Through study completion, up to 5 years
PFS
progression-free survival will be measured from the day of randomization to the date of first documented disease progression or death by any cause.
Measured: Through study completion, up to 5 years
RD
Duration of remission will be measured for responding patients from the end of initial treatment to the date of first documented disease progression or death by any cause.
Measured: week 19 up to 5,5 years follow up
Time to next anti-lymphoma treatment
will be measured from the date of randomization to the date of first documented start of a new chemotherapy, radiotherapy or immunotherapy.
Measured: Through study completion, up to 6.5 years
Overall Survival
will be determined from the date of randomization to the date of death irrespective of cause.
Measured: Through study completion, up to 5 years
Number of SAEs
Therapy-related toxicities according to the NCI-CTC-criteria will be compared for both treatment arms during the initial treatment and the consolidation treatment period.
Measured: Through study completion, up to 5 years
Frequency of Hospitalization
The days of hospitalisation will be compared for both treatment arms during the initial treatment, the consolidation treatment period and the first two years after the end of consolidation.
Measured: Through study completion, up to 3 years (per patient)
Duration of Hospitalization
The duration of hospitalisation will be compared for both treatment arms during the initial treatment, the consolidation treatment period and the first two years after the end of consolidation.
Measured: Through study completion, up to 3 years (per patient)
Supportive Care
The number of blood transfusions, the application of growth factors and the days of treatment with i.v. antibiotics will be compared for both treatment arms
Measured: Through study completion, up to 5 years
Incidence of secondary transformation to aggressive lymphoma
Incidence of secondary transformation to aggressive lymphoma
Measured: Through study completion, up to 5 years
Number of AEs
Incidence of secondary malignancies
Measured: Through study completion, up to 5 years
Number of participants that had completed the therapy regularly (including: Total cumulative dose of obinutuzumab and bendamustine, number of cycles, duration of treatment)
Measured: Through study completion, up to 5 years
QoL
Quality of Life Analysis scale measurements using the QLQ-C30 questionnaires are collected over time and will be compared for patients receiving OBINUTUZUMAB single agent versus OBINUTUZUMAB plus bendamustine.
Measured: Through study completion, up to 5 years
Comorbidity assessment will be performed by using the Instrumental Activities of Daily Living (=IADL)
With the Instrumental Activities of Daily Living (=IADL) the functional status) will be analysed (=instrument to assess independent living skills) The instrument is most useful for identifying how a person is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale. Historically, women were scored on all 8 areas of function; men were not scored in the domains of food preparation, housekeeping, laundering. However, current recommendations are to assess all domains for both genders. Persons are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).
Measured: Through study completion, up to 6.5 years
Comorbidity assessment will be performed by using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G)
This can be used to measure the burden of current and chronic illnesses in the older adult.This scoring system measures the chronic medical illness ("morbidity") burden while taking into consideration the severity of chronic diseases in 14 items representing individual body systems.
The general rules for severity rating are:
0→No problem affecting that system.
- Current mild problem or past significant problem.
- Moderate disability or morbidity and/or requires first line therapy.
- Severe problem and/or constant and significant disability and/or hard to control chronic problems.
- Extremely severe problem and/or immediate treatment required and/or organ failure and/or severe functional impairment.
Measured: Through study completion, up to 5 years
Comorbidity assessment will be performed by using the G 8 (=geriatric) 8 screening score
The G8 screening tool was developed to separate fit older cancer patients who were able to receive standard treatment from those that should undergo a geriatric assessment to guide tailoring of therapy. The assessment includes (instrumental) activities of daily living, cognition, mood, nutritional status, mobility, polypharmacy and social support. G8 is an independent predictor of mortality within the first year after inclusion (hazard ratio 3.93; 95 % confidence interval 1.67-9.22, p < 0.001). The G-8 Score is a screening tool containing 8 questions. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start12 Dec 2017
- Primary completion30 Nov 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent Non-hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Wolfgang Hiddemann
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Mundipharma Research GmbH & Co KG
- Responsible party
- Sponsor-investigator, Prof. Dr. Wolfgang Hiddemann, Ludwig-Maximilians - University of Munich
- Investigators
- Wolfgang Hiddemann, Prof.Dr., Study chair, Hospital of the University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492775
- Sponsor's protocol ID
- 2016-000755-27
- Other IDs
- 2016
- Acronym
- GABe2016
- Status last verified
- Mar 2023
- First submitted
- 4 Dec 2017
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of Single Agent GA101 Versus GA101 Plus Bendamustine Followed by GA101
- ClinicalTrials.gov ID
- NCT03492775
- Acronym / sponsor ID
- GABe2016 / 2016-000755-27
- Conditions
- Indolent Non-hodgkin Lymphoma
- Keywords
- indolent lymphoma, Obinutuzumab, GA101, Bendamustine, medically non-fit patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Prof. Dr. Wolfgang HiddemannUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Mundipharma Research GmbH & Co KG
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, 'compromised' patients and in all older patients (≥ 60 years). For the assessment of the antilymphoma activity the overall response rate (ORR)" will be applied as primary endpoint.
Overall response is defined as complete or partial response after 19 - 21 weeks.
Detailed description
Study design:
This is a randomized, open-label, multicenter phase II trial with a parallel-group design of two groups.
Randomization and Interventions:
Randomization between Obinutuzumab single agent treatment versus Obinutuzumab plus Bendamustine followed by Obinutuzumab
Treatment plans:
Arm A: Obinutuzumab single agent Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1
If at least 'stable disease':
Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 Arm B: Obinutuzumab plus Bendamustine Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 plus Bendamustine 70 mg/m2 iv d1+2 of each of four 28 -day cycles
If at least 'stable disease':
Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45
The project attempts to establish an evidence based treatment strategy for medically non-fit advanced stage FL-patients who are not eligible for standard therapeutic immunochemotherapy approaches to improve their long term perspectives.
It will furthermore provide a prospectively generated data set which will link performance in the assessment scores IADL, G8 and CIRS-G to medical fitness as judged by the treating physician. The generated data will allow using geriatric and functional tests to define medical fitness and to provide a more solid basis for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A:Obinutuzumab single agent | Active comparator | Drug: ObinutuzumabObinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 If at least 'stable disease': Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 |
| Arm B:Obinutuzumab plus Bendamustine | Active comparator | Drug: Obinutuzumab, Drug: BendamustineObinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles and on Days 8 and 15 of Cycle 1 plus Bendamustine 70 mg/m2 iv d1+2 of each of four 28 -day cycles If at least 'stable disease': Obinutuzumab flat dose of 1000 mg at weeks 21, 29, 37 and 45 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Medically nonfit" patients < 60 years defined by
- o ECOG > 2 or ECOG 0-2 with co-morbidities excluding intensive therapy according to local investigator's discretion
- All patients ≥ 60 years in case of decision of investigator and patient to apply a reduced Treatment
- Documentation of the CIRS-G, IADL, G8 and ECOG Scores before start of treatment
- Histologically confirmed follicular lymphoma grade I, II or IIIa with material available for central pathology review
Key exclusion criteria (20 listed)
- "Medically fit" patients < 60 years with the option for more intensive induction therapy such as R-CHOP
- Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma)
- Grade IIIb follicular lymphoma
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).
- Regular use of corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone.
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 |
|---|---|---|
| ObinutuzumabAlso: GA 101Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies. | Drug | Arm A:Obinutuzumab single agent, Arm B:Obinutuzumab plus Bendamustine |
| BendamustineAlso: Bendamustine hydrochloride; RibomustinBendamustine belongs formally to the alkylators, but has been shown to have a unique mechanism of action. The dose limiting toxicity of bendamustine is its reversible suppression of bone marrow function with drops in leukocyte and thromobocyte counts. | Drug | Arm B:Obinutuzumab plus Bendamustine |
Primary outcome
ORR
Time frame: week 19 to 21
Overall response is defined as complete or partial response at the end of the initial treatment phase (after 19-21 weeks).
18 secondary outcomes
Event free survival, EFS
Time frame: through study completion, up to 5 years
CR
Time frame: End of Induction of each patient, week 19 - 21
TTF
Time frame: Through study completion, up to 5 years
PFS
Time frame: Through study completion, up to 5 years
RD
Time frame: week 19 up to 5,5 years follow up
Time to next anti-lymphoma treatment
Time frame: Through study completion, up to 6.5 years
Overall Survival
Time frame: Through study completion, up to 5 years
Number of SAEs
Time frame: Through study completion, up to 5 years
Frequency of Hospitalization
Time frame: Through study completion, up to 3 years (per patient)
Duration of Hospitalization
Time frame: Through study completion, up to 3 years (per patient)
Supportive Care
Time frame: Through study completion, up to 5 years
Incidence of secondary transformation to aggressive lymphoma
Time frame: Through study completion, up to 5 years
Number of AEs
Time frame: Through study completion, up to 5 years
Number of participants that had completed the therapy regularly (including: Total cumulative dose of obinutuzumab and bendamustine, number of cycles, duration of treatment)
Time frame: Through study completion, up to 5 years
QoL
Time frame: Through study completion, up to 5 years
Comorbidity assessment will be performed by using the Instrumental Activities of Daily Living (=IADL)
Time frame: Through study completion, up to 6.5 years
Comorbidity assessment will be performed by using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G)
Time frame: Through study completion, up to 5 years
Comorbidity assessment will be performed by using the G 8 (=geriatric) 8 screening score
Time frame: Through study completion, up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- 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.
Wolfgang Hiddemann, Prof.Dr. study chair
Hospital of the University of Munich
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 Obinutuzumab and Bendamustine in people with Indolent Non-hodgkin Lymphoma, run by Prof. Dr. Wolfgang Hiddemann at 1 site in Germany.
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 23 inclusion and 20 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 31 Mar 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ORR (time frame: week 19 to 21). 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 31 Mar 2023.