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Cell Therapy

Allogeneic Blood or Bone Marrow Transplant for T-Cell Immunodeficiency Disorders

Phase 2

Recruiting

Led By Dimana Dimitrova, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 4 years

T-cell infiltration of liver, spleen, lymph nodes, marrow, lungs, gut, or other organs by T cells, as evidenced by laboratory, radiographic, and/or anatomic pathology evaluation, resulting in organ dysfunction and/or organomegaly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up +28, +42, +60, +100, +180, and 1 year after hct

Awards & highlights

Study Summary

This trial is studying allogeneic blood or bone marrow transplant to see if it is safe and effective in treating people with T-cell problems.

Who is the study for?

This trial is for people aged 4 and older with T-cell disorders, such as immune deficiencies or lymphoproliferative diseases. Participants must have certain medical conditions like abnormal T-cell function or specific genetic mutations affecting the immune system. They need to be in a stable condition to undergo transplant procedures and agree to use contraception if of childbearing potential.Check my eligibility

What is being tested?

The study tests whether transferring healthy blood stem cells from one person (donor) to another (recipient) can effectively treat various T-cell related health issues. It involves screening, preparation including chemotherapy, receiving donor stem cells through a catheter, and follow-up visits.See study design

What are the potential side effects?

Potential side effects include reactions to medications used during conditioning like chemotherapy, risk of infection due to immunosuppression, organ inflammation from graft-versus-host disease (GVHD), complications from bone marrow collection in donors, and general anesthesia risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 4 years old.

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My organs are enlarged or not working well due to T-cell infiltration.

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I have a latent herpesvirus infection in my T cells.

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I have a T-cell disorder due to an immune system problem.

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My liver function tests are within the specific limits for the treatment I am receiving.

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I have or had hemophagocytic lymphohistiocytosis.

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My blood or bone marrow has a specific type of immune cell called large granular lymphocytes.

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My lung function tests meet the required levels, or I don't need extra oxygen and can breathe normally.

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My kidneys work well enough, with a creatinine clearance rate of 50 mL/min or higher.

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I have a blood disorder affecting one or more cell types needing transfusions or support.

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I have an ongoing active Epstein-Barr virus infection.

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I have a genetic mutation that affects my immune system.

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I have ADA2 deficiency causing low white blood cells, anemia, or low platelets needing regular treatment.

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I have had long or repeated fevers due to an immune system problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ +28, +42, +60, +100, +180, and 1 year after hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~+28, +42, +60, +100, +180, and 1 year after hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and +28, +42, +60, +100, +180, and 1 year after hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To estimate the percentage of recipients with >50% donor T cell chimerism and graft-failure free survival

Secondary outcome measures

Event-free survival

Incidence of Acute Graftversus-host disease

Graft-vs-Host Disease

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: 2/IOC ArmExperimental Treatment3 Interventions

Immunosuppression Only Conditioning Arm

Group II: 1/RIC ArmExperimental Treatment3 Interventions

Reduced Intensity Conditioning Arm

Group III: 3/donor armActive Control1 Intervention

Healthy Donor- Donors for recipients in arm 1 or arm 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GVHD Prophylaxis

2002

Completed Phase 1

~20

Reduced Intensity Conditioning

2008

Completed Phase 1

~30

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,312 Total Patients Enrolled

85 Trials studying Lymphoproliferative Disorders

67,805 Patients Enrolled for Lymphoproliferative Disorders

Dimana Dimitrova, M.D.Principal InvestigatorNational Cancer Institute (NCI)

1 Previous Clinical Trials

254 Total Patients Enrolled

1 Trials studying Lymphoproliferative Disorders

254 Patients Enrolled for Lymphoproliferative Disorders

Media Library

Allogeneic HSC (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03663933 — Phase 2

Lymphoproliferative Disorders Research Study Groups: 1/RIC Arm, 2/IOC Arm, 3/donor arm

Lymphoproliferative Disorders Clinical Trial 2023: Allogeneic HSC Highlights & Side Effects. Trial Name: NCT03663933 — Phase 2

Allogeneic HSC (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03663933 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the status of GVHD Prophylaxis with regard to FDA authorization?

"GVHD Prophylaxis is deemed as moderately safe with a score of 2, since it has completed Phase 2 trials which established some evidence for safety but not efficacy."

Answered by AI

Could potential participants join this experiment presently?

"Confirmed. The clinical trial's page on clinicaltrials.gov confirms that the study, which was initially announced on September 4th 2018, is still actively recruiting participants from two different locations and needs 177 patients in total."

Answered by AI

What is the scope of patient participation in this experimental research?

"Yes, according to the clinicaltrials.gov database, this medical trial is still recruiting participants who first posted on September 4th 2018 and was last updated November 19th 2022. The study requires 177 patients across two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation

2018. "Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03663933.