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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy Group | Experimental | Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections |
|
| Monotherapy Group | Experimental | Recombinant Human Interleukin-2 Injections as a monotherapy |
|
| Control Group | No Intervention | non-intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocyte count and its subgroup count | Dynamic changes in lymphocyte count and its subgroup count | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| NK cells | Changes in NK cells | Up to 36 months |
| Infection | Incidence of infections | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijuan Lin | Contact | 15960283462 | zjuan_lin@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhijuan Lin | The First Aiffiliated hosptical of xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhijuan Lin | Recruiting | Xiamen | Fujian | China |
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|
|
| Recombinant Human Interleukin-2 Injections | Drug | Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days. |
|
|
| Treatment interruption | Rate of treatment interruption or delay. | Up to 36 months |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008231 | Lymphopenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077596 | Thymalfasin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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