NCT04436367 is a clinical trial in Severe Aplastic Anemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Who is sponsoring NCT04436367?

NCT04436367 is sponsored by National Heart, Lung, and Blood Institute (NHLBI).

What condition does NCT04436367 study?

NCT04436367 studies Severe Aplastic Anemia.

Is NCT04436367 still recruiting?

NCT04436367 is currently completed. Last updated 29 September 2022.

Last reviewed 2022-09-29 · How we verify

NCT04436367

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Retrospective Study of Patients With Severe Aplastic Anemia Who Developed High Risk Clonal Evolution With Chromosome 7 Abnormalities After Immunosuppressive Therapy

Completed Last updated 29 September 2022

What this trial tests

trial in Severe Aplastic Anemia in 38 participants. Completed in 15 March 2022.

Timeline

15 June 2020

Primary endpoint
22 April 2021

15 March 2022

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	38
Start date	15 June 2020
Primary completion	22 April 2021
Estimated completion	15 March 2022
Sites	1 location across United States

Conditions studied

Severe Aplastic Anemia — all drugs for Severe Aplastic Anemia →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

2 and older, any sex, with Severe Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Severe aplastic anemia (SAA) is a form of bone marrow failure. It usually results from a cytotoxic T cell attack on the marrow stem cell. Two treatments can be used for SAA. One is allogeneic hematopoietic stem cell transplant (HSCT). The other is immunosuppressive treatment (IST). In most cases, HSCT or IST works. But for some people, clonal evolution occurs after IST. One of the most common forms of clonal evolution is chromosome 7 abnormalities. These have a poor prognosis. HSCT can be used to treat them. Researchers do not know why clonal evolution happens. They want to look at data from past studies to learn more. Objective: To compare the data of people with SAA who developed chromosome 7 abnormalities between those who ultimately received HSCT versus those who received chemotherapy alone or supportive care. Eligibility: Adults and children with SAA who were enrolled on NHLBI protocol 12-H-0150, 06-H-0034, 03-H-0249, 03-H-0193, 00-H-0032, or 90-H-0146 Design: This study uses data from past studies. The participants in those studies have allowed their data to be used in future research. Researchers will review participants medical records. They will collect clinical data, such as notes, test results, and imaging scans. They will also collect the research data gathered as part of the original study. Researchers will enter the data into an in-house database. It is password protected. All data will be kept in secure network drives or in sites that comply with NIH security rules. Other studies may be added in the future.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Severe Aplastic Anemia

Currently open trials in the same condition.

NCT06622694 — CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia · Phase 1 · recruiting
NCT06517641 — Clinical Trial of Upfront Haploidentical or Unrelated Donor BMT to Restore Normal Hematopoiesis in Aplastic Anemia · Phase 2 · recruiting
NCT06695741 — Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia · Phase 2 · recruiting
NCT06412497 — MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Se · Phase 2 · recruiting
NCT06378060 — Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia · Phase 2 · recruiting

Other National Heart, Lung, and Blood Institute (NHLBI) trials

Trials by the same sponsor.

NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease · Phase 1 · not yet recruiting
NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System · NA · enrolling by invitation
NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction · not yet recruiting
NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti · not yet recruiting
NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04436367 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 29 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04436367.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing