B-cell Lymphoma RefractoryPhase 1IOSI-LND-001NCT01535989
Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
A Phase 1 study testing Inotuzumab Ozogamicin and Temsirolimus in people with B-cell Lymphoma Refractory, run by Cristiana Sessa at 3 sites in Switzerland.
Trial summary
This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin, in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in patients with relapsed/refractory CD22+ B-cell non… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- B-cell Lymphoma Refractory
- What is being tested?
- Inotuzumab Ozogamicin and Temsirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Dec 2011to Jun 2016
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed relapsed or refractory CD22+ B-cell Non Hodgkin's Lymphomas
- No limitations on prior treatments. Patients must have progressed after at least one prior therapy.
- Adult patients (aged > 18yrs old).
- ECOG status ≤ 1.
- Life expectancy greater than 3 months.
- Adequate organ and marrow function.
Who cannot join
- Uncontrolled intercurrent illness
- Chronic obstructive or chronic restrictive pulmonary disease
- Hepatitis B, C and HIV
- Patients with known known central nervous system lymphoma involvement.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Oncology Institute of Southern Switzerland
Bellinzona, Canton Ticino, 6500
InselSpital, Universitätsspital Bern
Bern, Canton of Bern, 3010
Kantonsspital St.Gallen
San Gallen, San Gallen, 9007
About this study
Official title: A Phase I Study of Inotuzumab Ozogamicin (CMC-544) in Combination With Temsirolimus (CCI-779) in Patients With Relapsed or Refractory CD22-positive B-cell Non Hodgkin's Lymphomas
This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin, in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in combination with rituximab in patients with NHLs. This is the first study combining the two agents together. In the present study Inotuzumab Ozogamicin will be administered intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated every 28 days.
- Conditions
- B-cell Lymphoma Refractory
- Being tested
- Inotuzumab Ozogamicin, Temsirolimus
- Keywords
- B-cell Non Hodgkin's Lymphomas, CD22 positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inotuzumab OzogamicinDrug
Also called CMC-544
starting dose 0.8 mg/m2, d1 administration, q4wks
TemsirolimusDrug
Also called Torisel, CCI-779
starting dose of 15mg, weekly administration, q4ws
| Study group | Role | What they receive |
|---|---|---|
| intravenous | Experimental | dose escalation Receives: Drug: Inotuzumab Ozogamicin; Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with adverse events based on the CTCAE v.4
To determine the safety profile, establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Inotuzumab Ozogamicin in combination with Temsirolimus in patients with relapsed/refractory CD22+ B-cell NHLs
Measured: toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
Secondary outcomes (1)
Antitumor activity based on Cheson criteria
Measured: after 12-18 months form the first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell Lymphoma RefractoryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristiana Sessa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristiana Sessa, Oncology Institute of Southern Switzerland
- Investigators
- Anastasios Stathis, Dr., Principal investigator, Oncology Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535989
- Sponsor's protocol ID
- IOSI-LND-001
- Acronym
- IOSI-LND-001
- Status last verified
- Jun 2016
- First submitted
- 27 Jan 2012
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pirosa MC, Zhang L, Hitz F, Novak U, Hess D, Terrot T, Pascale M, Mazzucchelli L, Bertoni F, Cavalli F, Zucca E, Stathis A. A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leuk Lymphoma. 2022 Jan;63(1):117-123. doi: 10.1080/10428194.2021.1966780. Epub 2021 Aug 19.
PubMed 34407735
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Inotuzumab Ozogamicin (CMC-544) in Combination With Temsirolimus (CCI-779) in Patients With Relapsed or Refractory CD22-positive B-cell Non Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT01535989
- Acronym / sponsor ID
- IOSI-LND-001 / IOSI-LND-001
- Conditions
- B-cell Lymphoma Refractory
- Keywords
- B-cell Non Hodgkin's Lymphomas, CD22 positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cristiana SessaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Feb 2012 (estimated)
- 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.
This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin, in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in combination with rituximab in patients with NHLs. This is the first study combining the two agents together. In the present study Inotuzumab Ozogamicin will be administered intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated every 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous | Experimental | Drug: Inotuzumab Ozogamicin, Drug: Temsirolimusdose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically and/or cytologically confirmed relapsed or refractory CD22+ B-cell Non Hodgkin's Lymphomas
- No limitations on prior treatments. Patients must have progressed after at least one prior therapy.
- Adult patients (aged > 18yrs old).
- ECOG status ≤ 1.
- Life expectancy greater than 3 months.
Key exclusion criteria (4 listed)
- Uncontrolled intercurrent illness
- Chronic obstructive or chronic restrictive pulmonary disease
- Hepatitis B, C and HIV
- Patients with known known central nervous system lymphoma involvement.
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 |
|---|---|---|
| Inotuzumab OzogamicinAlso: CMC-544starting dose 0.8 mg/m2, d1 administration, q4wks | Drug | intravenous |
| TemsirolimusAlso: Torisel, CCI-779starting dose of 15mg, weekly administration, q4ws | Drug | intravenous |
Primary outcome
number of participants with adverse events based on the CTCAE v.4
Time frame: toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
To determine the safety profile, establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Inotuzumab Ozogamicin in combination with Temsirolimus in patients with relapsed/refractory CD22+ B-cell NHLs
1 secondary outcome
Antitumor activity based on Cheson criteria
Time frame: after 12-18 months form the first patient in
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 7 Jun 2016.
- Derived from this study: PubMed 34407735Pirosa MC, Zhang L, Hitz F, Novak U, Hess D, Terrot T, Pascale M, Mazzucchelli L, Bertoni F, Cavalli F, Zucca E, Stathis A. A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leuk Lymphoma. 2022 Jan;63(1):117-123. doi: 10.1080/10428194.2021.1966780. Epub 2021 Aug 19.
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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.
Anastasios Stathis, Dr. principal investigator
Oncology Institute of Southern Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inotuzumab Ozogamicin and Temsirolimus in people with B-cell Lymphoma Refractory, run by Cristiana Sessa at 3 sites in Switzerland.
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 6 inclusion and 4 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 7 Jun 2016. 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 Switzerland. 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 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.
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?
number of participants with adverse events based on the CTCAE v.4 (time frame: toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks). 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 NCT01535989, 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 7 Jun 2016.