Lymphoma, Non-HodgkinPhase 2CAPTURNCT03297606
Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
A Phase 2 study testing Olaparib, Dasatinib and Nivolumab plus Ipilimumab in people with Lymphoma, Non-Hodgkin and Multiple Myeloma, run by Canadian Cancer Trials Group at 10 sites in Canada.
Trial summary
Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid Tumors
- What is being tested?
- Olaparib, Dasatinib and Nivolumab plus Ipilimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 10 sitesCanada
- Study dates
- 23 Mar 2018to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid tumour (excluding primary brain tumours), multiple myeloma or B cell non-Hodgkin lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known to prolong life, or who has refused such treatment.
- ECOG performance status 0-2.
- Patients must have normal organ function as follows:
- Absolute neutrophil count: ≥ 1.5 x 10^9/L for solid tumours; ≥ 1.0 x 10^9/L for neurologic malignancies
- Platelets ≥ 75 x 10^9/L (or ≥ 50 x 10^9/L if bone marrow involvement by myeloma or lymphoma).
- Total bilirubin ≤ 1.5 x UNL.
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- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal value unless liver metastases are present in which case they must be < 5 x ULN;
- Serum creatinine ≤ 1.5 x UNL or calculated or measured creatinine clearance ≥ 50mg/min/1.73µ^2
- Patients must have measurable disease
- Results must be available from tumour genomic or protein expression testing (if used to identify genetic variants), from one of the initiatives / groups listed in protocol Appendix VII. The test may have been performed on the primary tumour or a metastatic deposit (including bone marrow), or blood, in a diagnostic or research laboratory and must reveal a potentially actionable variant.
- Patient consent (Main Study Consent for the screening step) must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to the screening step to document their willingness to participate
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre or a CCTG IND site. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
Who cannot join
- Patients with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or asymptomatic, corrected biochemical toxicities (e.g. hypothyroidism corrected by thyroid replacement), related to prior anti-tumour treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
- Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ one month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
- Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
- Patients with known left ventricular ejection fraction (LVEF) < 40%.
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- Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
- Patients with acute gastrointestinal bleeding within one month prior to the screening step.
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
- Lactating and nursing women
- Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Canada10 sites, 10 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Quincy Chu, 780 432-8248
- Recruiting
BCCA - Kelowna
Kelowna, British Columbia, V1Y 5L3
Sara Kristina Taylor, 250 712-3996
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Francisco Vera-Badillo
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9
Stephen Welch, 519 685-8640
- Recruiting
The Jewish General Hospital
Montreal, Quebec, H3T 1E2
Cristiano Ferrario, 514 398-8307
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
John Hilton, 613 737-7700 ext. 75086
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Kimberly Hagel, 306 766-2691
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Sunil K. Yadav, 306 655-2710
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Lillian Siu, 416 946-2911
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Daniel John Renouf, 604 877-6000 ext. 672357
About this study
Official title: Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial
Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. The purpose of this study is to find out what are the effects on a patient and their cancer when they are given a targeted therapy drug that is specific to an abnormal gene change in their cancer.
Read the detailed description
Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors to find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling and have 'druggable' changes identified in their cancers.
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
300mg taken twice daily
DasatinibDrug
100mg administered orally once daily
Nivolumab plus IpilimumabDrug
- Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase.
- Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.
AxitinibDrug
5mg orally twice daily
BosutinibDrug
500mg orally once daily
CrizotinibDrug
250mg orally twice daily
PalbociclibDrug
125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
SunitinibDrug
50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off
TemsirolimusDrug
25mg infused over a 30-60 minute period once a week
ErlotinibDrug
150mg orally, once daily
Trastuzumab plus PertuzumabDrug
Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion.
Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.
Vemurafenib plus CobimetinibDrug
Vemurafenib = 960 mg orally every 12 hours.
Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest
VismodegibDrug
150mg taken orally, once daily
TucatinibDrug
300mg taken orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Arm CLOSED, no patients recruited | Experimental | VEGFR1, VEGFR2, VEGFR3 Receives: Drug: Axitinib |
| Group 2 - Arm CLOSED, no patients recruited | Experimental | BCR-ABL, SRC Receives: Drug: Bosutinib |
| Group 3 - Arm CLOSED | Experimental | ALK, ROS1, MET Receives: Drug: Crizotinib |
| Group 4 - Arm CLOSED, no patients recruited | Experimental | KIT, PDGFRA, PDGFRB, ABL1 Receives: Drug: Dasatinib |
| Group 5 - Arm CLOSED | Experimental | EGFR Receives: Drug: Erlotinib |
| Group 6 - Arm CLOSED | Experimental | high mutation burden, POLE, POLD1 Receives: Drug: Nivolumab plus Ipilimumab |
| Group 7 - Arm CLOSED | Experimental | BRCA1, BRCA2, mutations in HRD Receives: Drug: Olaparib |
| Group 8 - Arm CLOSED | Experimental | CDKN2A, CDK4, CCND1, SMARCA4 Receives: Drug: Palbociclib |
| Group 9 Arm CLOSED | Experimental | CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL Receives: Drug: Sunitinib |
| Group 10 Arm CLOSED | Experimental | AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2 Receives: Drug: Temsirolimus |
| Group 11 - Arm CLOSED | Experimental | ERBB2 Receives: Drug: Trastuzumab plus Pertuzumab |
| Group 12 - Arm CLOSED | Experimental | BRAFV600 Receives: Drug: Vemurafenib plus Cobimetinib |
| Group 13 - Arm CLOSED | Experimental | PTCH1, SMO Receives: Drug: Vismodegib |
| Group 14 | Experimental | ERBB2 Receives: Drug: Tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate defined as the number of patients with complete response or partial response
over the total number of patients in a given cohort.
Measured: 4 years
Secondary outcomes (2)
Number and severity of adverse events grade >3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug
measured by CTCAE
Measured: 4 years
Progression-free survival by disease-appropriate objective criteria
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start23 Mar 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- AstraZeneca, Bristol-Myers Squibb, Hoffmann-La Roche, Pfizer, Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, Study chair, Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON CanadaDaniel J Renouf, Study chair, BCCA - Vancouver Cancer Centre, Vancouver BC, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297606
- Sponsor's protocol ID
- PM1
- Other IDs
- ESR-17-12831, CA209-9DL, ML39800, WI233446
- Acronym
- CAPTUR
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2017
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial
- ClinicalTrials.gov ID
- NCT03297606
- Acronym / sponsor ID
- CAPTUR / PM1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- AstraZeneca, Bristol-Myers Squibb, Hoffmann-La Roche, Pfizer, Seagen Inc.
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Sep 2017 (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.
Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. The purpose of this study is to find out what are the effects on a patient and their cancer when they are given a targeted therapy drug that is specific to an abnormal gene change in their cancer.
Detailed description
Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors to find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling and have 'druggable' changes identified in their cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Arm CLOSED, no patients recruited | Experimental | Drug: AxitinibVEGFR1, VEGFR2, VEGFR3 |
| Group 2 - Arm CLOSED, no patients recruited | Experimental | Drug: BosutinibBCR-ABL, SRC |
| Group 3 - Arm CLOSED | Experimental | Drug: CrizotinibALK, ROS1, MET |
| Group 4 - Arm CLOSED, no patients recruited | Experimental | Drug: DasatinibKIT, PDGFRA, PDGFRB, ABL1 |
| Group 5 - Arm CLOSED | Experimental | Drug: ErlotinibEGFR |
| Group 6 - Arm CLOSED | Experimental | Drug: Nivolumab plus Ipilimumabhigh mutation burden, POLE, POLD1 |
| Group 7 - Arm CLOSED | Experimental | Drug: OlaparibBRCA1, BRCA2, mutations in HRD |
| Group 8 - Arm CLOSED | Experimental | Drug: PalbociclibCDKN2A, CDK4, CCND1, SMARCA4 |
| Group 9 Arm CLOSED | Experimental | Drug: SunitinibCSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL |
| Group 10 Arm CLOSED | Experimental | Drug: TemsirolimusAKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2 |
| Group 11 - Arm CLOSED | Experimental | Drug: Trastuzumab plus PertuzumabERBB2 |
| Group 12 - Arm CLOSED | Experimental | Drug: Vemurafenib plus CobimetinibBRAFV600 |
| Group 13 - Arm CLOSED | Experimental | Drug: VismodegibPTCH1, SMO |
| Group 14 | Experimental | Drug: TucatinibERBB2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid tumour (excluding primary brain tumours), multiple myeloma or B cell non-Hodgkin lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known to prolong life, or who has refused such treatment.
- ECOG performance status 0-2.
- Patients must have normal organ function as follows:
- Patients must have measurable disease
- Results must be available from tumour genomic or protein expression testing (if used to identify genetic variants), from one of the initiatives / groups listed in protocol Appendix VII. The test may have been performed on the primary tumour or a metastatic deposit (including bone marrow), or blood, in a diagnostic or research laboratory and must reveal a potentially actionable variant.
Key exclusion criteria (11 listed)
- Patients with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or asymptomatic, corrected biochemical toxicities (e.g. hypothyroidism corrected by thyroid replacement), related to prior anti-tumour treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
- Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ one month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
- Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
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 |
|---|---|---|
| Olaparib300mg taken twice daily | Drug | Group 7 - Arm CLOSED |
| Dasatinib100mg administered orally once daily | Drug | Group 4 - Arm CLOSED, no patients recruited |
| Nivolumab plus Ipilimumab* Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase. * Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks. | Drug | Group 6 - Arm CLOSED |
| Axitinib5mg orally twice daily | Drug | Group 1 - Arm CLOSED, no patients recruited |
| Bosutinib500mg orally once daily | Drug | Group 2 - Arm CLOSED, no patients recruited |
| Crizotinib250mg orally twice daily | Drug | Group 3 - Arm CLOSED |
| Palbociclib125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days | Drug | Group 8 - Arm CLOSED |
| Sunitinib50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off | Drug | Group 9 Arm CLOSED |
| Temsirolimus25mg infused over a 30-60 minute period once a week | Drug | Group 10 Arm CLOSED |
| Erlotinib150mg orally, once daily | Drug | Group 5 - Arm CLOSED |
| Trastuzumab plus PertuzumabTrastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion. Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes. | Drug | Group 11 - Arm CLOSED |
| Vemurafenib plus CobimetinibVemurafenib = 960 mg orally every 12 hours. Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest | Drug | Group 12 - Arm CLOSED |
| Vismodegib150mg taken orally, once daily | Drug | Group 13 - Arm CLOSED |
| Tucatinib300mg taken orally, twice daily | Drug | Group 14 |
Primary outcome
Objective response rate defined as the number of patients with complete response or partial response
Time frame: 4 years
over the total number of patients in a given cohort.
2 secondary outcomes
Number and severity of adverse events grade >3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug
Time frame: 4 years
Progression-free survival by disease-appropriate objective criteria
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
Lillian Siu study chair
Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Daniel J Renouf study chair
BCCA - Vancouver Cancer Centre, Vancouver BC, Canada
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib, Dasatinib and Nivolumab plus Ipilimumab in people with Lymphoma, Non-Hodgkin and Multiple Myeloma, run by Canadian Cancer Trials Group at 10 sites in Canada.
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 13 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Dancey (613-533-6430, jdancey@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate defined as the number of patients with complete response or partial response (time frame: 4 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 27 Mar 2026.