Chronic Myeloid LeukemiaNCT00001432
The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers and Volunteers With Lymphoid or Hematologic Malignancies
An observational study of Chronic Myeloid Leukemia and Healthy, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Myeloid Leukemia, Healthy, Hematologic Neoplasm
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1995to Nov 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All volunteers at the Clinical Center will be recruited through and registered with the NIH Volunteer Office. Volunteers at collaborating institutions will be recruited through Associate Investigators at that institution according to institutionally IRB approved methods.
- All volunteers may be normal volunteers or have a diagnosis of a lymphoid/hematologic malignancy (chronic myelogenous leukemia, multiple myeloma, lymphoma, acute myelogenous leukemia, chronic lymphocytic leukemia, acute lymphocytic leukemia).
- To be eligible peripheral blood apheresis, all normal volunteers must have a hematocrit of greater than or equal to 36% and a peripheral platelet count of greater than or equal to 100,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a hematocrit of greater than or equal to 30% and a peripheral platelet count of greater than or equal to 100,000/mm(3). All volunteers, including those volunteers with lymphoid/hematologic malignancies, must have a white blood cell count of greater than or equal to 4,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a white blood cell count of less than 100,000/mm(3).
- To be eligible for venipuncture or bone marrow aspiration, normal volunteers and volunteers with lymphoid/hematologic malignancies must have no history of an abnormal bleeding tendency or documented predisposition to infection. For venipuncture and bone marrow aspiration, the peripheral blood platelet count of normal volunteers must be greater than 100,000/mm(3) and for volunteers with a lymphoid/hematologic malignancy, the platelet count must be greater than or equal to 50,000/mm(3).
- All normal volunteers and volunteers with a lymphoid/hematologic malignancy are eligible to receive apheresis (done only at the NIH Clinical Center), bone marrow sampling, or venipuncture. Apheresis will only be performed at the Clinical Center of the National Institutes of Health. Apheresis will not be peformed at collaborating institutions.
- Normal volunteers and volunteers with lymphoid/hematopoietic malignancies may donate samples by apheresis, venipuncture, and bone marrow sampling on multiple occasions. Repeated donation by apheresis will be allowed as long as a period of at least eight week has elapsed since a previous apheresis. Repeated donations of peripheral blood or bone marrow will be allowed as long as a period of at least four weeks has elapsed since a previous donation. For any given volunteer, the total number of aphereses will not exceed six per year and the total number of peripheral blood or bone marrow donations will not exceed eight per year. All normal and CML volunteers must undergo repeat physical examination and complete blood count evaluation to determine eligibility prior to donation.
- Normal volunteers and volunteers with lymphoid/hematologic malignancies will not be tested for HIV or hepatitis to determine eligibility for this protocol. However, DTM guidelines will require that patients undergoing apheresis with subsequent ex vivo elutriation of the collected products will be required to have testing for HIV and hepatitis B and C. Volunteers who are required to be tested for HIV and Hepatitis will be informed at the time of enrollment and will sign an appropriate informed consent for these tests. Volunteers who are found to be HIV positive or hepatitis B or C can still donate blood products, but these products will not be subjected to ex vivo elutriation.
- Volunteers with lymphoid/hematologic malignancies may be receiving therapy such as chemotherapy or chronic interferon alpha injections.
Who cannot join
- Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with significant history of cardiac, renal, pulmonary, or neurologic disease will be ineligible.
- Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with a known history of HIV or hepatitis B or C will be ineligible.
- Any normal volunteer or volunteer with a lymphoid/hematologic malignancy requiring chronic anticoagulation or steroid therapy will be ineligible.
- Any volunteer with a lymphoid/hematologic malignancy with a peripheral blast count that exceeds 25% or a total lymphocyte count that exceeds 100,000/mm(3) will be ineligible for apheresis.
- Volunteers with a lymphoid/hematologic malignancy who are currently enrolled in an experimental therapy on an NCI protocol will be ineligible.
- Any normal volunteer or volunteer with a lymphoid/Hematologic malignancy with known AIDS and/or hepatitis B or C will be excluded.
- Volunteers with a history of diabetes mellitus will be excluded from receiving [6,6-(2)H] or [U-(13)C9]-glucose infusions.
- A pregnancy test will be given to all female volunteers and volunteers who are pregnant will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of [6,6-(2)H(2)] or [U-(13)C(9)]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
Read the detailed description
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior [6,6-(2)H2] or [U-(13)C9]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of [6,6-(2)H2] or [U-(13)C9]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H2] or [U-(13)C9]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
- Conditions
- Chronic Myeloid Leukemia, Healthy, Hematologic Neoplasm, Lymphoma
- Keywords
- Purging, Apheresis, Long Term Culture, T Cells, Stem Cell
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hematologic Neoplasms, Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMar 1995
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid 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
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001432
- Sponsor's protocol ID
- 950086
- Other IDs
- 95-C-0086
- Status last verified
- Nov 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Mackall CL, Fleisher TA, Brown MR, Andrich MP, Chen CC, Feuerstein IM, Horowitz ME, Magrath IT, Shad AT, Steinberg SM, et al. Age, thymopoiesis, and CD4+ T-lymphocyte regeneration after intensive chemotherapy. N Engl J Med. 1995 Jan 19;332(3):143-9. doi: 10.1056/NEJM199501193320303.
PubMed 7800006Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.
PubMed 7919339Mackall CL, Bare CV, Granger LA, Sharrow SO, Titus JA, Gress RE. Thymic-independent T cell regeneration occurs via antigen-driven expansion of peripheral T cells resulting in a repertoire that is limited in diversity and prone to skewing. J Immunol. 1996 Jun 15;156(12):4609-16.
PubMed 8648103
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers and Volunteers With Lymphoid or Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00001432
- Acronym / sponsor ID
- 950086
- Conditions
- Chronic Myeloid Leukemia, Healthy, Hematologic Neoplasm, Lymphoma
- Keywords
- Purging, Apheresis, Long Term Culture, T Cells, Stem Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 1995
- Study completion
- Nov 2003
- First posted
- 4 Nov 1999 (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.
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of [6,6-(2)H(2)] or [U-(13)C(9)]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
Detailed description
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior [6,6-(2)H2] or [U-(13)C9]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of [6,6-(2)H2] or [U-(13)C9]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H2] or [U-(13)C9]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- All volunteers at the Clinical Center will be recruited through and registered with the NIH Volunteer Office. Volunteers at collaborating institutions will be recruited through Associate Investigators at that institution according to institutionally IRB approved methods.
- All volunteers may be normal volunteers or have a diagnosis of a lymphoid/hematologic malignancy (chronic myelogenous leukemia, multiple myeloma, lymphoma, acute myelogenous leukemia, chronic lymphocytic leukemia, acute lymphocytic leukemia).
- To be eligible peripheral blood apheresis, all normal volunteers must have a hematocrit of greater than or equal to 36% and a peripheral platelet count of greater than or equal to 100,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a hematocrit of greater than or equal to 30% and a peripheral platelet count of greater than or equal to 100,000/mm(3). All volunteers, including those volunteers with lymphoid/hematologic malignancies, must have a white blood cell count of greater than or equal to 4,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a white blood cell count of less than 100,000/mm(3).
- To be eligible for venipuncture or bone marrow aspiration, normal volunteers and volunteers with lymphoid/hematologic malignancies must have no history of an abnormal bleeding tendency or documented predisposition to infection. For venipuncture and bone marrow aspiration, the peripheral blood platelet count of normal volunteers must be greater than 100,000/mm(3) and for volunteers with a lymphoid/hematologic malignancy, the platelet count must be greater than or equal to 50,000/mm(3).
- All normal volunteers and volunteers with a lymphoid/hematologic malignancy are eligible to receive apheresis (done only at the NIH Clinical Center), bone marrow sampling, or venipuncture. Apheresis will only be performed at the Clinical Center of the National Institutes of Health. Apheresis will not be peformed at collaborating institutions.
Key exclusion criteria (8 listed)
- Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with significant history of cardiac, renal, pulmonary, or neurologic disease will be ineligible.
- Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with a known history of HIV or hepatitis B or C will be ineligible.
- Any normal volunteer or volunteer with a lymphoid/hematologic malignancy requiring chronic anticoagulation or steroid therapy will be ineligible.
- Any volunteer with a lymphoid/hematologic malignancy with a peripheral blast count that exceeds 25% or a total lymphocyte count that exceeds 100,000/mm(3) will be ineligible for apheresis.
- Volunteers with a lymphoid/hematologic malignancy who are currently enrolled in an experimental therapy on an NCI protocol will be ineligible.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7800006Mackall CL, Fleisher TA, Brown MR, Andrich MP, Chen CC, Feuerstein IM, Horowitz ME, Magrath IT, Shad AT, Steinberg SM, et al. Age, thymopoiesis, and CD4+ T-lymphocyte regeneration after intensive chemotherapy. N Engl J Med. 1995 Jan 19;332(3):143-9. doi: 10.1056/NEJM199501193320303.
- Background: PubMed 7919339Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.
- Background: PubMed 8648103Mackall CL, Bare CV, Granger LA, Sharrow SO, Titus JA, Gress RE. Thymic-independent T cell regeneration occurs via antigen-driven expansion of peripheral T cells resulting in a repertoire that is limited in diversity and prone to skewing. J Immunol. 1996 Jun 15;156(12):4609-16.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Myeloid Leukemia and Healthy, 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 4 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001432, which also lists 3 linked publications.
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 4 Mar 2008.