Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with high-risk acute B-lymphoblastic leukemia

Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared

Eligible for autologous hematopoietic stem cell transplantation

No major organ dysfunction

Disqualifiers

Combined with malignant tumors of other organs

With a serious infection that is not under control

Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive

Patients who have had an allergic reaction to the drugs used in this study or similar drugs

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous hematopoietic stem cell transplantation combined with CD19-CART

    Biological/Vaccine

    Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Autologous hematopoietic stem cell transplantation combined with CD19-CARTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse rate within 2 years

Time frame
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Secondary outcomes

1

Non-relapse mortality

Time frame
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
2

Progression-free survival

Time frame
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
3

Overall survival rate

Time frame
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
4

Incidence of infection

Time frame
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Other outcomes

Sponsors and contacts

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