Acute Lymphoblastic LeukemiaNCT00923442
Biology Studies of Hematologic Cancers
An observational study of Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (MDS), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will collect tumor samples from people with cancers of the blood, bone marrow, or lymph glands for laboratory study of the biology of these conditions. Such studies contribute to a better understanding of cancer biology and to the development of new treatments. Read more about this study
- Who is it for?
- Ages 1 year to 120 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS), Non-Hodgkins Lymphoma
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2004to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tumor tissue of patients whose ages range from birth to 75 years old diagnosed with any hematologic malignancy or pre-malignant blood disorder
Who may be able to join
- Confirmed pathological diagnosis of any hematologic malignancy or pre-malignant blood disorder, including but not restricted to the following:
- Acute Lymphocytic Leukemia (ALL)
- Acute Myelogenous Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Chronic Myelogenous Leukemia (CML)
- Juvenile Myelomonocytic Leukemia (JMML, J-CML)
Show all 12Show fewer
- Non-Hodgkin's Lymphoma (NHL)
- Hodgkin's Disease
- Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care.
- Age: >= 1 years.
- Prior therapy: no restrictions
- Subject, parent/guardian, legally authorized representative (LAR), or durable power of attorney must be able to give informed consent and sign the informed consent document.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Hematologic Malignancy Biology Study
This study will collect tumor samples from people with cancers of the blood, bone marrow, or lymph glands for laboratory study of the biology of these conditions. Such studies contribute to a better understanding of cancer biology and to the development of new treatments. Planned studies include:
- Examination of individual cancer cells and to search for differences compared to other types of cancer and normal cells
- Examination of the chromosomes and genes in cancer cells and to search for differences compared to other types of cancer and normal cells
- Development of sensitive methods to detect small amounts of cancer that remain after treatment
- Search for new cancer proteins that might serve as targets for treatment
- Investigation of methods to develop cancer vaccines.
Read more
Patients from >= 1 to 75 years of age with acute lymphocytic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, and other hematologic malignancies may be eligible for this study.
Blood or bone marrow samples will be collected when sampling is required for the patient's medical care. Cells from some individuals will be grown in test tubes, establishing cell lines or in animals, establishing xenograft models. (A xenograft is transplantation of cells of one species to another species.)
Read the detailed description
Background:
Laboratory-based investigations have contributed to an improved understanding of pathophysiology and to the development of new therapies for hematologic malignancies.
The aim of this protocol is to facilitate biologic study of leukemias, pre-malignant conditions, myelodysplastic syndromes, lymphomas, and other blood disorders.
This is a sample acquisition protocol for targeted study of hematologic malignancies by a collaborative network of NIH investigators from multiple Institutes/Centers.
Objective:
This biology protocol is designed to allow sample acquisition for use in the study of hematologic malignancies. A variety of laboratory investigations designed to support NIH translational trials, to apply new methodologies in the study of cellular, and molecular biology, to probe for new therapeutic targets; and to develop new treatment approaches will be performed.
Eligibility:
Diagnosis of any hematologic malignancy or pre-malignant conditions, including but not restricted to the following: Acute Lymphocytic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelogenous Leukemia (CML), Juvenile Myelomonocytic Leukemia (JMML, J-CML), Non-Hodgkin s Lymphoma (NHL), Hodgkin s Disease
Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care.
Patient age: >= 1 year
Design:
Biologic assays relevant to the investigation of hematologic malignancies will be performed in an exploratory fashion, some studies are developmental, i.e., assay design in support of current or planned CC clinical trials. Others are standard assays that will be applied in attempt to identify new targets or test new therapeutic approaches.
.
- Conditions
- Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS), Non-Hodgkins Lymphoma, Acute Myelogenous Leukemia, Hodgkins Lymphoma
- Keywords
- Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Pediatric Blood Disorders, Hodgkins and non-Hodgkins lymphoma, MDS, Natural History
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Leukemia, Myeloid, Acute, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients (from >/= 1 to 75 years old) diagnosed with any hematologic malignancy or pre-malignant condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue acquisition for lab investigations
The examination of biologic assays relevant to the investigation of hematologic malignancies
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start24 Feb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John W Glod, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923442
- Sponsor's protocol ID
- 040102
- Other IDs
- 04-C-0102
- Status last verified
- 16 Oct 2026
- First submitted
- 17 Jun 2009
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematologic Malignancy Biology Study
- ClinicalTrials.gov ID
- NCT00923442
- Acronym / sponsor ID
- 040102
- Conditions
- Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS), Non-Hodgkins Lymphoma, Acute Myelogenous Leukemia, Hodgkins Lymphoma
- Keywords
- Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Pediatric Blood Disorders, Hodgkins and non-Hodgkins lymphoma, MDS, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Feb 2004 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect tumor samples from people with cancers of the blood, bone marrow, or lymph glands for laboratory study of the biology of these conditions. Such studies contribute to a better understanding of cancer biology and to the development of new treatments. Planned studies include:
- Examination of individual cancer cells and to search for differences compared to other types of cancer and normal cells
- Examination of the chromosomes and genes in cancer cells and to search for differences compared to other types of cancer and normal cells
- Development of sensitive methods to detect small amounts of cancer that remain after treatment
- Search for new cancer proteins that might serve as targets for treatment
- Investigation of methods to develop cancer vaccines.
Patients from >= 1 to 75 years of age with acute lymphocytic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, and other hematologic malignancies may be eligible for this study.
Blood or bone marrow samples will be collected when sampling is required for the patient's medical care. Cells from some individuals will be grown in test tubes, establishing cell lines or in animals, establishing xenograft models. (A xenograft is transplantation of cells of one species to another species.)
Detailed description
Background:
Laboratory-based investigations have contributed to an improved understanding of pathophysiology and to the development of new therapies for hematologic malignancies.
The aim of this protocol is to facilitate biologic study of leukemias, pre-malignant conditions, myelodysplastic syndromes, lymphomas, and other blood disorders.
This is a sample acquisition protocol for targeted study of hematologic malignancies by a collaborative network of NIH investigators from multiple Institutes/Centers.
Objective:
This biology protocol is designed to allow sample acquisition for use in the study of hematologic malignancies. A variety of laboratory investigations designed to support NIH translational trials, to apply new methodologies in the study of cellular, and molecular biology, to probe for new therapeutic targets; and to develop new treatment approaches will be performed.
Eligibility:
Diagnosis of any hematologic malignancy or pre-malignant conditions, including but not restricted to the following: Acute Lymphocytic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelogenous Leukemia (CML), Juvenile Myelomonocytic Leukemia (JMML, J-CML), Non-Hodgkin s Lymphoma (NHL), Hodgkin s Disease
Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care.
Patient age: >= 1 year
Design:
Biologic assays relevant to the investigation of hematologic malignancies will be performed in an exploratory fashion, some studies are developmental, i.e., assay design in support of current or planned CC clinical trials. Others are standard assays that will be applied in attempt to identify new targets or test new therapeutic approaches.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients (from >/= 1 to 75 years old) diagnosed with any hematologic malignancy or pre-malignant condition |
Who may qualify
- Ages
- 1 year to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tumor tissue of patients whose ages range from birth to 75 years old diagnosed with any hematologic malignancy or pre-malignant blood disorder
Key inclusion criteria (12 listed)
- Confirmed pathological diagnosis of any hematologic malignancy or pre-malignant blood disorder, including but not restricted to the following:
- Acute Lymphocytic Leukemia (ALL)
- Acute Myelogenous Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Chronic Myelogenous Leukemia (CML)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue acquisition for lab investigations
Time frame: 1 Month
The examination of biologic assays relevant to the investigation of hematologic malignancies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John W Glod, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (MDS), run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue acquisition for lab investigations (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.