Hematological MalignancyPhase 2NCT06584006
Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
A Phase 2 study testing Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections and Recombinant Human Interleukin-2 Injections in people with Hematological Malignancy and Lymphocytopenia, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Lymphocytopenia
- What is being tested?
- Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections and Recombinant Human Interleukin-2 Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 29 Feb 2028
- 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
- Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
- Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
- Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
- Estimated creatinine clearance rate ≥ 30 mL/min.
- AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
- ECOG ≤ 2.
- Able to understand and voluntarily provide informed consent.
Who cannot join
- Active autoimmune disease.
- Patients considered to have a malignant T-cell clone.
- Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
- Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils <1.0×10^9/L, HB<70g/L, PLT<50×10^9/L).
- HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
- Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.
Show all 11Show fewer
- Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1/2 inhibitors, etc.) within the past 5 days.
- Psychiatric disorders that would interfere with study participation.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation.
- Consideration of allergy to Thymalfasin or Interleukin-2.
- Any other condition that the researcher believes makes the patient unsuitable for this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhijuan Lin
Xiamen, Fujian
Zhijuan Lin, 15960283462, zjuan_lin@126.com
About this study
Official title: A Phase II, Single-Center, Randomized Controlled Clinical Trial Evaluating the Efficacy of Thymalfasin and Recombinant Human Interleukin-2 Injections in Treating Lymphocytopenia in Patients With Malignant Hematological Tumors
To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors
Read the detailed description
A prospective, randomized controlled study is proposed to evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Recombinant Human Interleukin-2 Injections as a monotherapy, and a non-intervention group. Follow-up observations will also be conducted.
- Conditions
- Hematological Malignancy, Lymphocytopenia
- Being tested
- Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Recombinant Human Interleukin-2 Injections
- Medical subject headings
- Hematologic Neoplasms, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymalfasin for injection in combination with Recombinant Human Interleukin-2 InjectionsDrug
Also called Combination Therapy Group
Thymalfasin for injection 1.6mg subcutaneous injection once daily (qd) for 7 days, and Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.
Recombinant Human Interleukin-2 InjectionsDrug
Also called Monotherapy Group
Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Experimental | Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections Receives: Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections |
| Monotherapy Group | Experimental | Recombinant Human Interleukin-2 Injections as a monotherapy Receives: Drug: Recombinant Human Interleukin-2 Injections |
| Control Group | No intervention | non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte count and its subgroup count
Dynamic changes in lymphocyte count and its subgroup count
Measured: Up to 36 months
Secondary outcomes (3)
NK cells
Changes in NK cells
Measured: Up to 36 months
Infection
Incidence of infections
Measured: Up to 36 months
Treatment interruption
Rate of treatment interruption or delay.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Sep 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijuan Lin, The First Affiliated Hospital of Xiamen University
- Investigators
- Zhijuan Lin, Principal investigator, The First Aiffiliated hosptical of xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584006
- Sponsor's protocol ID
- XMDYYYXYK-12
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Center, Randomized Controlled Clinical Trial Evaluating the Efficacy of Thymalfasin and Recombinant Human Interleukin-2 Injections in Treating Lymphocytopenia in Patients With Malignant Hematological Tumors
- ClinicalTrials.gov ID
- NCT06584006
- Acronym / sponsor ID
- XMDYYYXYK-12
- Conditions
- Hematological Malignancy, Lymphocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 4 Sep 2024 (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.
To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors
Detailed description
A prospective, randomized controlled study is proposed to evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections, Recombinant Human Interleukin-2 Injections as a monotherapy, and a non-intervention group. Follow-up observations will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Drug: Thymalfasin for injection in combination with Recombinant Human Interleukin-2 InjectionsThymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections |
| Monotherapy Group | Experimental | Drug: Recombinant Human Interleukin-2 InjectionsRecombinant Human Interleukin-2 Injections as a monotherapy |
| Control Group | No intervention | –non-intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
- Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
- Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
- Estimated creatinine clearance rate ≥ 30 mL/min.
- AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
Key exclusion criteria (11 listed)
- Active autoimmune disease.
- Patients considered to have a malignant T-cell clone.
- Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
- Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils <1.0×10^9/L, HB<70g/L, PLT<50×10^9/L).
- HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
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 |
|---|---|---|
| Thymalfasin for injection in combination with Recombinant Human Interleukin-2 InjectionsAlso: Combination Therapy GroupThymalfasin for injection 1.6mg subcutaneous injection once daily (qd) for 7 days, and Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days. | Drug | Combination Therapy Group |
| Recombinant Human Interleukin-2 InjectionsAlso: Monotherapy GroupRecombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days. | Drug | Monotherapy Group |
Primary outcome
Lymphocyte count and its subgroup count
Time frame: Up to 36 months
Dynamic changes in lymphocyte count and its subgroup count
3 secondary outcomes
NK cells
Time frame: Up to 36 months
Infection
Time frame: Up to 36 months
Treatment interruption
Time frame: Up to 36 months
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Hematological Malignancy
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Zhijuan Lin principal investigator
The First Aiffiliated hosptical of xiamen University
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 Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections and Recombinant Human Interleukin-2 Injections in people with Hematological Malignancy and Lymphocytopenia, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 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 19 Sep 2024. 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 China. 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 Zhijuan Lin (15960283462, zjuan_lin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte count and its subgroup count (time frame: Up to 36 months). 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 19 Sep 2024.