Haematological MalignancyPhase 2NIVALLONCT03146468
Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
A Phase 2 study testing Nivolumab Injection in people with Haematological Malignancy, run by Melbourne Health at 1 site in Australia.
Trial summary
This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT). Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematological Malignancy
- What is being tested?
- Nivolumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- 8 May 2017to 1 Mar 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
- Prior allogeneic stem cell transplant for a haematological malignancy
- Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
- Immunosuppression cessation for minimum of 2 weeks
- Life expectancy > 2 months
- ECOG performance status 0-2
- Greater than or equal to 30% CD3+ donor chimerism
Show all 10Show fewer
- Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
- AST and ALT ≤ 3 times upper limit of normal
- Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
- Signed written informed consent
Who cannot join
- Current evidence of any grade of GVHD
- Prior history of grade 2 or higher acute GVHD
- Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
- Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
- Positive hepatitis B virus surface antigen
- Positive hepatitis C virus antibody
- Known human immunodeficiency virus infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).
Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.
- Conditions
- Haematological Malignancy
- Being tested
- Nivolumab Injection
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab InjectionDrug
Also called Opdivo
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab treatment arm | Experimental | Nivolumab injection 3mg/kg intravenously every 2 weeks Receives: Drug: Nivolumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft versus host disease
Cumulative incidence of graft versus host disease
Measured: 8 weeks
Graft versus host disease
Cumulative incidence of graft versus host disease
Measured: 24 weeks
Graft versus host disease
Cumulative incidence of graft versus host disease
Measured: 48 weeks
Secondary outcomes (4)
Overall response rate
Complete remission and partial remission
Measured: 8 weeks
Overall response rate
Complete remission and partial remission
Measured: 16 weeks
Overall response rate
Complete remission and partial remission
Measured: 24 weeks
Overall response rate
Complete remission and partial remission
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start8 May 2017
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ritchie, FRACP, PhD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146468
- Sponsor's protocol ID
- RMH 2016.281
- Acronym
- NIVALLO
- Status last verified
- Sep 2021
- First submitted
- 7 May 2017
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared by researchers outside of this clinical trial
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03146468
- Acronym / sponsor ID
- NIVALLO / RMH 2016.281
- Conditions
- Haematological Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 10 May 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.
This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).
Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab treatment arm | Experimental | Drug: Nivolumab InjectionNivolumab injection 3mg/kg intravenously every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prior allogeneic stem cell transplant for a haematological malignancy
- Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
- Immunosuppression cessation for minimum of 2 weeks
- Life expectancy > 2 months
- ECOG performance status 0-2
Key exclusion criteria (7 listed)
- Current evidence of any grade of GVHD
- Prior history of grade 2 or higher acute GVHD
- Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
- Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
- Positive hepatitis B virus surface antigen
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 |
|---|---|---|
| Nivolumab InjectionAlso: OpdivoHuman monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor | Drug | Nivolumab treatment arm |
Primary outcome
Graft versus host disease
Time frame: 8 weeks
Cumulative incidence of graft versus host disease
Graft versus host disease
Time frame: 24 weeks
Cumulative incidence of graft versus host disease
Graft versus host disease
Time frame: 48 weeks
Cumulative incidence of graft versus host disease
4 secondary outcomes
Overall response rate
Time frame: 8 weeks
Overall response rate
Time frame: 16 weeks
Overall response rate
Time frame: 24 weeks
Overall response rate
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No. IPD will not be shared by researchers outside of this clinical trial
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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.
David Ritchie, FRACP, PhD principal investigator
Melbourne Health
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 Nivolumab Injection in people with Haematological Malignancy, run by Melbourne Health at 1 site in Australia.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. 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 Australia. 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?
Results are not available in the source record.
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?
Graft versus host disease (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 Sep 2021.