RecruitingNCT06608342Updated Sep 23, 2024

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

A Phase 2 interventional study of Autologous hematopoietic stem cell transplantation combined with CD19-CART in Acute Lymphoblastic Leukemia ALL, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
Started Jun 2024; still recruiting 2 years 3 months later.

Phase: Phase 2
Study type: Interventional
Enrollment: 20
Allocation: Non-randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Read the detailed description

Conditions studied

Acute Lymphoblastic Leukemia ALL

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Keywords

inaticabtagene autoleucel
auto-HSCT

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

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Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
Other patients deemed unsuitable for inclusion by the investigators

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Autologous hematopoietic stem cell transplantation combined with CD19-CART
Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

Non-relapse mortality
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Progression-free survival
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Overall survival rate
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Incidence of infection
Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Study locations

1 of 1 sites recruiting

NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
Tianjin, Tianjin 300000, China
- erlie EL Jiang, Doctor · Contact · jiangerlie@ihcams.ac.cn · +86-15122538106
- rongli RL zhang · Contact · +86-13194633608
- erlie EL jiang, Doctor · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: Undecided — Haven\&#39;t thought it through yet

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06608342
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Collaborators: Juventas Cell Therapy Ltd.
Responsible party: Sponsor
First posted: Sep 23, 2024
Start date: Jun 25, 2024
Primary completion: May 30, 2026 (estimated)
Completion: May 30, 2028 (estimated)
Last update: Sep 23, 2024

Study contacts

erlie EL Jiang

Contact

jiangerlie@ihcams.ac.cn

+86-15122538106

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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