Leukemia, Lymphocytic, AcuteNCT00185523
Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
An observational study of Leukemia, Lymphocytic, Acute and Leukemia, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors. Read more about this study
- Who is it for?
- Ages 4 weeks to 55 years
- Conditions the study is for
- Leukemia, Lymphocytic, Acute, Leukemia, Leukemia Acute Promyelocytic Leukemia (APL)
- What is being tested?
- Allogeneic hematopoietic cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Apr 2009
- 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 4 weeks to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary care clinic
Who may be able to join
- HLA identical family member
- Donor or guardian must be competent to give consent
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
Who cannot join
- Evidence of active infection or active hepatitis
- Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
- Previous allogeneic stem cell/bone marrow transplant
- Pregnant or lactating patients
- 4 Exclusion criteria (Donor):
- Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
Show all 9Show fewer
- Donors who are HIV+ or hepatitis B antigen +
- History of allergic reaction to G-CSF
- Female donors must be post-menopausal or have a negative pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase
The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.
Read the detailed description
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic Phase
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Leukemia Acute Promyelocytic Leukemia (APL), Leukemia Acute Lymphoid Leukemia (ALL), Leukemia Chronic Myelogenous Leukemia (CML), Leukemia Acute Myeloid Leukemia (AML)
- Being tested
- Allogeneic hematopoietic cell transplantation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Leukemia, Promyelocytic, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic hematopoietic cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CML in first Chronic Phase or Accelerated Phase | Busulfan/cyclophosphamide Day -7: Busulfan 1.0 mg/kg IV q6 hrs** Day -6: Busulfan 1.0 mg/kg IV q6 hrs Day -5: Busulfan 1.0 mg/kg IV q6 hrs Day -4: Busulfan 1.0 mg/kg IV q6 hrs Day -3: Cyclophosphamide 60 mg/kg Day -2: Cyclophosphamide 60 mg/kg Day -1: rest Day 0: Allogeneic PBSC infusion Receives: Procedure: Allogeneic hematopoietic cell transplantation | |
| AML and ALL in first or second remission | FTBI/VP-16 Day -7: FTBI 120 cGy x 3 fractions Day -6: FTBI 120 cGy x 2 fractions Day -5: FTBI 120 cGy x 3 fractions Day -4: FTBI 120 cGy x 3 fractions* Day -3: VP-16 at 60 mg/kg Day -2: rest Day -1: rest Day 0: Allogeneic PBSC infusion Receives: Procedure: Allogeneic hematopoietic cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
Measured: no known
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, AcuteStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ginna Laport, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185523
- Sponsor's protocol ID
- BMT142
- Other IDs
- 78149, NCT00185523, 12570
- Status last verified
- Jun 2016
- First submitted
- 12 Sep 2005
- Last updated
- 16 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase
- ClinicalTrials.gov ID
- NCT00185523
- Acronym / sponsor ID
- BMT142
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Leukemia Acute Promyelocytic Leukemia (APL), Leukemia Acute Lymphoid Leukemia (ALL), Leukemia Chronic Myelogenous Leukemia (CML), Leukemia Acute Myeloid Leukemia (AML)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Sep 2005 (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.
The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.
Detailed description
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic Phase
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CML in first Chronic Phase or Accelerated Phase | – | Procedure: Allogeneic hematopoietic cell transplantationBusulfan/cyclophosphamide Day -7: Busulfan 1.0 mg/kg IV q6 hrs** Day -6: Busulfan 1.0 mg/kg IV q6 hrs Day -5: Busulfan 1.0 mg/kg IV q6 hrs Day -4: Busulfan 1.0 mg/kg IV q6 hrs Day -3: Cyclophosphamide 60 mg/kg Day -2: Cyclophosphamide 60 mg/kg Day -1: rest Day 0: Allogeneic PBSC infusion |
| AML and ALL in first or second remission | – | Procedure: Allogeneic hematopoietic cell transplantationFTBI/VP-16 Day -7: FTBI 120 cGy x 3 fractions Day -6: FTBI 120 cGy x 2 fractions Day -5: FTBI 120 cGy x 3 fractions Day -4: FTBI 120 cGy x 3 fractions* Day -3: VP-16 at 60 mg/kg Day -2: rest Day -1: rest Day 0: Allogeneic PBSC infusion |
Who may qualify
- Ages
- 4 weeks to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- HLA identical family member
- Donor or guardian must be competent to give consent
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
Key exclusion criteria (9 listed)
- Evidence of active infection or active hepatitis
- Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
- Previous allogeneic stem cell/bone marrow transplant
- Pregnant or lactating patients
- Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic hematopoietic cell transplantation | Procedure or surgery | AML and ALL in first or second remission, CML in first Chronic Phase or Accelerated Phase |
Primary outcome
To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
Time frame: no known
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
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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.
Ginna Laport principal investigator
Stanford University
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 Leukemia, Lymphocytic, Acute and Leukemia, run by Stanford University 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Jun 2016. 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 was stopped early. Results are not available in the source record.
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?
To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors. (time frame: no known). 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 16 Jun 2016.