Completed

Evaluation, Treatment and Training Protocol for Patients With Bone Marrow Failure States, Isolated or Multilineage Cytopenias, Metastatic Solid Tumors, or Hematologic Malignancies

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cytopenia+10

+ Agranulocytosis

+ Blood Platelet Disorders

From 2 to 110 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: November 1993
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: October 8, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: November 8, 1993

Actual date on which the first participant was enrolled.

This protocol is designed to allow the evaluation, follow up, and standard medical care of patients (and when appropriate, their stem cell donor) with bone marrow failure states, cytopenias, metastatic solid tumors, or hematologic malignancies not currently entered on an active NHLBI protocol or not being screened for an active NHLBI research protocol. Its purpose is to allow investigation into the hematologic problems of these patients for the primary purpose of teaching and furthering general hematologic knowledge. The ability to evaluate and treat patients with a wide variety of hematologic disease is critical to maintaining our accreditation as a hematology fellowship program and training our fellows to be competent hematologists, as well as for keeping all staff, including senior staff, up-to-date and familiar with the evaluation and treatment of patients with a wide spectrum of hematologic disease. It also allows the NHLBI investigators to evaluate patients referred with rare or as yet undiagnosed hematologic problems, both potentially benefiting the patient and stimulating new research directions for the NHLBI in the future. Periodic follow-up and treatment of patients previously entered on NHLBI protocols in order to monitor the long-term course of the underlying hematologic state and the consequences of experimental treatments is also required for fellowship training, and for maintenance of good referral relationships with patients and their physicians.

NCT00001397
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: October 8, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1452 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 110 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAgranulocytosisBlood Platelet DisordersHemic and Lymphatic DiseasesLeukocyte DisordersLeukopeniaNeoplasmsNeoplasms by SiteAnemiaHematologic DiseasesNeutropeniaThrombocytopeniaHematologic Neoplasms

Criteria

INCLUSION CRITERIA: Patients (and when appropriate the patient's stem cell donor) may be entered on this protocol at the discretion of the Principal and/or Associate Investigators if : An investigator decides that it is in the best interest of the patient/donor and the Branch for the patient to be enrolled in this protocol while awaiting a decision on eligibility for other protocols; or after enrollment on another protocol, or to allow careful evaluation of patients with unique or rare disorders of direct interest to the Branch; or with more common disorders for fellowship teaching purposes. The patient or the patient's guardian is capable of informed consent and signs the consent form. The consent form will be signed by parents or guardians of patients under the age of 18. Age greater than or equal to 2 and weight greater than 12 kg.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center