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Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors

ConditionsHematological MalignancyLymphocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Recombinant Human Interleukin-2 Injections

    Drug

    Recombinant Human Interleukin-2 Injections 1 million units subcutaneous injection qd for 7 days.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Combination Therapy GroupExperimental treatment 1 intervention
Group B: Monotherapy GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Lymphocyte count and its subgroup count

Dynamic changes in lymphocyte count and its subgroup count

Time frame
Up to 36 months

Secondary outcomes

1

NK cells

Changes in NK cells

Time frame
Up to 36 months
2

Infection

Incidence of infections

Time frame
Up to 36 months
3

Treatment interruption

Rate of treatment interruption or delay.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Xiamen University

Lead sponsor

Source ClinicalTrials.gov
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