LymphomaPhase 1NCT06892119
Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation
A Phase 1 study testing Celrixafor in people with Lymphoma and Myeloma, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Generic plerixafor use at reduced-dose for mobilization on HSCT transplant Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Celrixafor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteMexico
- Study dates
- 9 Dec 2019to 30 Nov 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
- Patients > 18 years old who signed our informed consent
- Normal CBC count (Hb > 10, WBC 4.0-11.00, plt > 100,000)
Who cannot join
- Patients with HIV, Hepatitis C, Hepatitis B diagnosis
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-reduced Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Patients With Lymphoma and Myeloma
Generic plerixafor use at reduced-dose for mobilization on HSCT transplant
Read the detailed description
The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.
- Being tested
- Celrixafor
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelrixaforDrug
Use a reduced-dose of generic plerixafor
| Study group | Role | What they receive |
|---|---|---|
| Generic plerixafor | Active comparator | Use a reduced-dose of generic plerixafor (0.12 mcg/Kg) Receives: Drug: Celrixafor |
| Placebo | Placebo comparator | Use of a subcutaenous application of saline solution Receives: Drug: Celrixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest
The objective of this study is to demonstrate that the use of a low dose of the generic form of plerixafor is effective in increasing the amount of hematopoietic cells (stem cells).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start9 Dec 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study comparing placebo vs generic plerixafor
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Homero Gutierrez-Aguirre, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Olga G Cantú-Rodríguez, MD, Study chair, Universidad Autónoma de Nuevo León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892119
- Sponsor's protocol ID
- HE19-00013
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gutierrez-Aguirre CH, Alvarado-Navarro DM, Palomares-Leal A, Mejia-Jaramillo G, Salazar-Riojas R, Leon AG, Colunga-Pedraza PR, Sotomayor-Duque G, Jaime-Perez JC, Cantu-Rodriguez OG, Del Carmen Tarin-Arzaga L, Flores-Jimenez JA, Gomez-Almaguer D. Reduced-dose plerixafor as a mobilization strategy in autologous hematopoietic cell transplantation: a proof of concept study. Transfusion. 2019 Dec;59(12):3721-3726. doi: 10.1111/trf.15547. Epub 2019 Oct 16.
PubMed 31618456
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-reduced Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Patients With Lymphoma and Myeloma
- ClinicalTrials.gov ID
- NCT06892119
- Acronym / sponsor ID
- HE19-00013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Mar 2025 (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.
Generic plerixafor use at reduced-dose for mobilization on HSCT transplant
Detailed description
The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel study comparing placebo vs generic plerixafor
| Arm | Type | Receives |
|---|---|---|
| Generic plerixafor | Active comparator | Drug: CelrixaforUse a reduced-dose of generic plerixafor (0.12 mcg/Kg) |
| Placebo | Placebo comparator | Drug: CelrixaforUse of a subcutaenous application of saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
- Patients > 18 years old who signed our informed consent
- Normal CBC count (Hb > 10, WBC 4.0-11.00, plt > 100,000)
Key exclusion criteria (2 listed)
- Patients with HIV, Hepatitis C, Hepatitis B diagnosis
- Pregnant women
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 |
|---|---|---|
| CelrixaforUse a reduced-dose of generic plerixafor | Drug | Generic plerixafor, Placebo |
Primary outcome
Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest
Time frame: 1 year
The objective of this study is to demonstrate that the use of a low dose of the generic form of plerixafor is effective in increasing the amount of hematopoietic cells (stem cells).
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 27 Mar 2025.
- Results publication: PubMed 31618456Gutierrez-Aguirre CH, Alvarado-Navarro DM, Palomares-Leal A, Mejia-Jaramillo G, Salazar-Riojas R, Leon AG, Colunga-Pedraza PR, Sotomayor-Duque G, Jaime-Perez JC, Cantu-Rodriguez OG, Del Carmen Tarin-Arzaga L, Flores-Jimenez JA, Gomez-Almaguer D. Reduced-dose plerixafor as a mobilization strategy in autologous hematopoietic cell transplantation: a proof of concept study. Transfusion. 2019 Dec;59(12):3721-3726. doi: 10.1111/trf.15547. Epub 2019 Oct 16.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Olga G Cantú-Rodríguez, MD study chair
Universidad Autónoma de Nuevo León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celrixafor in people with Lymphoma and Myeloma, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 3 inclusion and 2 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 27 Mar 2025. 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 Mexico. 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 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?
Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest (time frame: 1 year). 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 NCT06892119, 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 27 Mar 2025.