Stem Cell Transplant ComplicationsPhase 2NCT05421416
Loratadine for the Prevention of G-CSF-related Bone Pain
A Phase 2 study testing Loratadine in people with Stem Cell Transplant Complications, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2024to 1 Dec 2026
- 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
- A histologically or cytologically documented lymphoma or multiple myeloma
- Next line of therapy is autologous stem cell transplant
- Adult ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Life expectancy of at least 12 weeks.
- The absence of any additional poorly controlled systemic disease that is directly contraindicated or places subject at significant risk, including but not limited to: congestive heart failure, diabetes mellitus, cirrhosis or liver failure, renal failure.
- Able to adhere to study protocols and visit schedules
Who cannot join
- Hypersensitivity or intolerance to antihistamines
- Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.
- Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
- New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
About this study
Official title: Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization
The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.
- Conditions
- Stem Cell Transplant Complications
- Being tested
- Loratadine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Loratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.
PlaceboDrug
Placebo sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Loratadine Arm | Experimental | Loratadine 10mg, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days. Receives: Drug: Loratadine |
| Placebo Arm | Placebo comparator | Placebo capsule, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Pain Severity (Brief Pain Inventory)
Reduction in bone pain will be measured as a change from pre-G-CSF baseline in the Brief Pain Inventory (BPI), with median values compared for each trial arm. BPI pain severity will be compared as a composite score (sum of individual pain values divided by 4).
Measured: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
Bone Pain Interference (Brief Pain Inventory)
Reduction on impact on daily life as a composite score out of 10 as measured on the Brief Pain Inventory (BPI). BPI pain interference will be compared as a composite score (sum of individual pain interference values divided by 7).
Measured: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
Bone pain severity (QLQ-BM22)
Change in bone pain measured pre and post G-CSF in EORTC QLQ-BM22. QLQ-BM22 questionnaires will be compared to the post vs pre-treatment values and calculated as a composite sum (i.e. pre-treatment total score subtracted from post-treatment total score).
Measured: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).
Secondary outcomes (6)
Stem cell mobilization efficacy
Normalized mean and absolute number number of stem cells collected at the end of the mobilization protocol
Measured: Single measurement at the end of mobilization protocol (max day 8)
Mean time to stem cell re-engraftment
Time in days between stem cell re-infusion and the measurement on complete blood count (CBC) of an absolute neutrophil count of greater than 500/mm3 for 3 consecutive days.
Measured: Single measurement during stem cell re-infusion (max day 8)
Rate of plerixafor use during in each study arm
Proportion of patients in each study arm that require use of plerixafor during stem cell mobilization
Measured: Single measurement after all patients have completed end of treatment.
Rate of pain control use
Proportion of patients in each study arm that require use of additional pain control methods while receiving G-CSF.
Measured: Single measurement after all patients complete mobilization (max day 8)
Qualitative breakthrough of pain control use
Type of medication used to control additional pain while receiving G-CSF.
Measured: Qualitative description of analgesic type after all patients complete mobilization (max day 8)
Progression free survival
Time between the date of treatment initiation and the date of disease progression or death (whatever the cause), whichever occurs first)
Measured: Patients will be followed for 1 year after completion of the study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start28 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421416
- Sponsor's protocol ID
- IIT-0020
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization
- ClinicalTrials.gov ID
- NCT05421416
- Acronym / sponsor ID
- IIT-0020
- Conditions
- Stem Cell Transplant Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jun 2022 (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 research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loratadine Arm | Experimental | Drug: LoratadineLoratadine 10mg, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days. |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo capsule, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A histologically or cytologically documented lymphoma or multiple myeloma
- Next line of therapy is autologous stem cell transplant
- Adult ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (4 listed)
- Hypersensitivity or intolerance to antihistamines
- Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.
- Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
- New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
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 |
|---|---|---|
| LoratadineLoratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors. | Drug | Loratadine Arm |
| PlaceboPlacebo sugar pill | Drug | Placebo Arm |
Primary outcome
Bone Pain Severity (Brief Pain Inventory)
Time frame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
Reduction in bone pain will be measured as a change from pre-G-CSF baseline in the Brief Pain Inventory (BPI), with median values compared for each trial arm. BPI pain severity will be compared as a composite score (sum of individual pain values divided by 4).
Bone Pain Interference (Brief Pain Inventory)
Time frame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
Reduction on impact on daily life as a composite score out of 10 as measured on the Brief Pain Inventory (BPI). BPI pain interference will be compared as a composite score (sum of individual pain interference values divided by 7).
Bone pain severity (QLQ-BM22)
Time frame: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).
Change in bone pain measured pre and post G-CSF in EORTC QLQ-BM22. QLQ-BM22 questionnaires will be compared to the post vs pre-treatment values and calculated as a composite sum (i.e. pre-treatment total score subtracted from post-treatment total score).
6 secondary outcomes
Stem cell mobilization efficacy
Time frame: Single measurement at the end of mobilization protocol (max day 8)
Mean time to stem cell re-engraftment
Time frame: Single measurement during stem cell re-infusion (max day 8)
Rate of plerixafor use during in each study arm
Time frame: Single measurement after all patients have completed end of treatment.
Rate of pain control use
Time frame: Single measurement after all patients complete mobilization (max day 8)
Qualitative breakthrough of pain control use
Time frame: Qualitative description of analgesic type after all patients complete mobilization (max day 8)
Progression free survival
Time frame: Patients will be followed for 1 year after completion of the study treatment.
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 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Loratadine in people with Stem Cell Transplant Complications, run by AHS Cancer Control Alberta at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 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. Some participants in this study may receive a placebo. 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 Michael Chu, MD (780-432-8757, Michael.Chu@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Pain Severity (Brief Pain Inventory) (time frame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).). 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 5 Feb 2026.