#1 Clinical Trials Search in Europe

Study of DDCART-CD19 cells with cyclophosphamide and fludarabine for children and young adults (up to 39 years) with recurrent acute leukemia after stem cell transplant

2 1 1 1

What is this study about?

This study focuses on patients with Relapsed Acute Leukemia, a condition where blood cancer returns after previous treatment. The study tests a new treatment called DDCART-CD19, which uses specially modified immune cells (T-cells) that have been engineered to target cancer cells displaying a specific marker called CD19. This treatment is being studied in children and young adults whose leukemia has returned after receiving a stem cell transplant from a donor.

Before receiving the DDCART-CD19 cells, patients will undergo preparation treatment with cyclophosphamide and fludarabine phosphate. These medications are given through an intravenous line to help prepare the body for the cell therapy. The treatment involves collecting immune cells from the original stem cell donor, modifying them in a laboratory, and then giving them back to the patient through an intravenous infusion.

The purpose of this study is to determine how well DDCART-CD19 works and how safe it is for treating relapsed leukemia. The study will monitor patients for two years after receiving the treatment to see how their body responds and whether the leukemia stays in remission. Researchers will also track how long the modified cells remain in the patient’s blood and how they affect the disease.

1 Initial assessment

Your eligibility for the study will be confirmed based on the presence of CD19-positive acute leukemia that has returned or persisted after previous treatments

A bone marrow examination will be performed to confirm the presence of specific cancer cells

Your overall health status will be evaluated using a performance score system

2 Preparation phase

You will receive two medications through an intravenous line (IV):

Fludarabine phosphate – given as an infusion into your vein

Cyclophosphamide – also given as an infusion into your vein

These medications help prepare your body for the cell therapy

3 Cell therapy administration

You will receive DDCART-CD19 cells through an intravenous infusion

These are specially modified immune cells designed to target your type of leukemia

The infusion is given as a single dose

4 Monitoring period – first month

Your response to the treatment will be evaluated during the first 30 days after the cell infusion

Regular blood tests will be performed to monitor your condition

Your bone marrow will be examined to check for signs of remission

5 Long-term follow-up

Your progress will be monitored for up to 2 years after the cell therapy

Regular checkups will track how long the treatment cells remain in your blood

The status of your B-cells (a type of immune cell) will be monitored

Additional bone marrow examinations may be performed to confirm continued remission

Who Can Join the Study?

  • Age requirement: Between 6 months and 39 years old
  • Must have CD19-positive acute leukemia that has either:
    • Come back after stem cell transplant, or
    • Persisted after previous CAR-T cell therapy
  • Must have at least 0.05% of leukemia cells (CD19+ blast cells) in bone marrow testing, or have disease outside the bone marrow
  • Must not have signs of moderate to severe rejection of transplanted cells (GVHD) for at least 4 weeks without taking immunosuppressive medications
  • Must have good enough physical function, measured by:
    • Lansky score of 50 or higher (for patients under 16 years)
    • Karnofsky score of 50 or higher (for patients 16 years and older)
  • The original stem cell donor must be available

Who Cannot Join the Study?

  • Active and uncontrolled infections (including bacterial, viral, or fungal infections)
  • Presence of graft-versus-host disease (a condition where transplanted cells attack the recipient’s body) requiring systemic therapy
  • Severe heart conditions including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Recent heart attack (within last 6 months)
  • Severe lung disease requiring oxygen therapy
  • Severe kidney problems requiring dialysis
  • Severe liver disease with impaired function
  • Active other types of cancer
  • Pregnancy or breastfeeding
  • Known allergies to study medications
  • Central nervous system involvement (cancer spread to brain or spinal cord)
  • Participation in other clinical trials within past 30 days
  • Mental conditions that prevent understanding of study requirements
  • HIV, active hepatitis B, or active hepatitis C infection

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Nosokomeio Paidon I Agia Sofia Athens Greece
Evangelismos S.A. Athens Greece
Uomlrpqqwd Gomepzh Hdyadaly Afolmyk Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Recruiting
01.10.2021

Trial locations

Investigated drugs:

DDCAR-CD19 is a type of CAR T-cell therapy where immune cells (T cells) are taken from stem cell donors and modified to target CD19, a protein found on certain leukemia cells. These modified cells are designed to recognize and fight cancer cells in patients with acute leukemia who have previously received a stem cell transplant. The cells are manufactured using a special device called CliniMACS Prodigy.

Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is a procedure where healthy blood-forming stem cells from a donor are used to replace the patient’s diseased or damaged bone marrow. This treatment is used as a foundation therapy before the CAR T-cell treatment.

Investigated diseases:

Relapsed Acute Leukemia – A blood and bone marrow cancer that has returned after a period of improvement or remission. The disease occurs when immature blood cells in the bone marrow develop abnormally and multiply uncontrollably. These abnormal cells interfere with the production of normal blood cells and can spread to other parts of the body. During relapse, the symptoms may include fatigue, frequent infections, easy bruising or bleeding, bone pain, and fever. The disease affects both children and adults, with symptoms typically developing rapidly over days or weeks.

Trial ID:
2024-516091-15-00
Protocol code:
ELPIDA-ALLOCART-01
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study testing AZD3632 alone or with other anticancer drugs in adults with acute leukemia or myelodysplastic syndromes with HOX gene overexpression

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Germany Italy

  • Study on CD19+ Lymphoid Disease Using Genetically Modified T Cells for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin’s Lymphoma

    Recruiting

    1 1 1
    Investigated drugs:
    Germany