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HAPALL: CAR T Cells After Stem Cell Transplant

About this study 

Some patients with blood cancers such as B-cell acute lymphoblastic leukemia (B-ALL) and certain lymphomas do not get better with standard treatment. Sometimes the treatment does not work well or sometimes cancer comes back. Researchers are looking for better ways to treat these patients. 

In this study, patients will get a bone marrow (stem cell) transplant from a donor. The cells from the donor are first modified using a special process to make them safer to give to patients. Before getting these donor cells, the patient gets chemotherapy. This treatment clears out unhealthy cells and makes room for the donor’s stem cells.  

After the transplant, the immune system is weak for a while. This increases the risk of infections and cancer returning. To help protect patients, this study adds another treatment. 

About 2 weeks after the transplant, patients will get special immune cells called CD19 CAR T cells. These cells come from the same donor as the transplant. In the lab, the cells are changed so they can find and attack cancer cells that have a marker (protein) called CD19. These CAR T cells are made from “memory” immune cells. The cells may work longer and may be less likely to harm healthy tissues and can also help with infections. 

Patients stay in the hospital for several weeks. Doctors watch closely for side effects. These include infections, graft versus host disease, and other side effects. Blood and bone marrow tests help doctors see how well the donor cells are working and if any cancer remains. After patients leave the hospital, they return for clinic visits and long-term follow-up. 

The goal of this study is to learn if giving CD19 CAR T cells after a stem cell transplant is safe and helpful. Researchers also want to learn if this approach can help keep the cancer from returning, protect patients from infections and study how the immune system recovers. 

Eligibility overview 

  • Has CD19‑positive B‑cell acute lymphoblastic leukemia that is high risk, returned after treatment (relapsed), or hard to treat (refractory) 
  • Eligible for a stem cell transplant using a matched donor or partially matched family member donor 
  • No prior allogeneic stem cell transplant 
  • No uncontrolled infections at the time of enrollment 

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

HAPALL: CD45RADepleted CD19CAR T Cell Consolidation After TCRαβ+ T Cell/CD19 B Cell–Depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma

Study goal:

To study CD19 CAR T cells after allogeneic stem cell transplant for highrisk CD19positive ALL.

Diagnosis:

Acute lymphoblastic leukemia

Age:

Up to 21 years

Clinical trial categories:

Blood Disorders Childhood Cancer Leukemia Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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