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NCT01019876 · ClinicalTrials.gov registry record · Phase 2

Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases

A Phase 2 study, sponsored by Columbia University.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target

NCT01019876 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 38 participants.

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The verdict

NCT01019876, a Phase 2 study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target

Study Summary

This study proposes the use of a reduced intensity chemotherapy/radiation therapy regimen followed by stem cell transplantation, as compared to standard ablative chemotherapy regimens associated with stem cell transplantation, in a population of patients with non-malignant diseases (non-cancer). Eligible patients will have a non-malignant disease in one of the following four strata: bone marrow failure syndromes, immunodeficiencies, inborn errors of metabolism, or histiocytoses. Patients will be assigned to therapy according to diagnosis. Patients will be stratified by disease into one of four strata and treatment regimens will be based on specific disease criteria and conditions. Although these diseases are non-malignant in name, they are often malignant by nature of the disease progression, treatment and associated complications.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Alemtuzumab
  • DRUG Rabbit Anti-thymocyte Globulin

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2002-09
Est. Completion 2021-09-07
Phase Phase 2

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT01019876

The ClinicalTrials.gov registry entry for NCT01019876 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01019876 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01019876 about?

NCT01019876 is a clinical study titled "Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases". This study proposes the use of a reduced intensity chemotherapy/radiation therapy regimen followed by stem cell transplantation, as compared to standard ablative chemotherapy regimens associated with stem cell transplantation, in a population of patients with non-malignant diseases (non-cancer). Eli...

What is the current status of trial NCT01019876?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2002-09. Estimated completion is 2021-09-07.

What interventions are being tested in trial NCT01019876?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Alemtuzumab (DRUG), Rabbit Anti-thymocyte Globulin (DRUG).

Who is sponsoring clinical trial NCT01019876?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.