Acute Myelogenous LeukemiaNCT00594308
In-Vivo Activated T-Cell Depletion to Prevent GVHD
A study testing Cyclophosphamide, Fludarabine and Cyclosporine in people with Acute Myelogenous Leukemia and Acute Lymphocytic Leukemia, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Cyclophosphamide, Fludarabine and Cyclosporine
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol
- Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.
Who cannot join
- Active CNS disease (the presence of leukemic blasts in the CSF)
- Pregnancy or breast-feeding
- SGOT >3x upper limit of normal
- Creatinine >2 or creatinine clearance <50cc/hr.
- Fractional shortening by echocardiogram not within normal limits per institution
- Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia
- Prior allogeneic transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Universtiy Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.
This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Lymphoma, Non-Hodgkin's
- Being tested
- Cyclophosphamide, Fludarabine, Cyclosporine, Mycophenolate mofetil, Basiliximab
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Anemia, Refractory, with Excess of Blasts, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
60mg/kg/day for two consecutive days (-7,-6).
FludarabineDrug
25mg/m2/day for 5 consecutive days
CyclosporineDrug
3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
BasiliximabDrug
20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Acute Grade II-IV GVHD
Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
Measured: until 30 days after stem cell transplant
Secondary outcomes (4)
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
Measured: until 30 days after stem cell transplant
Number of Days for Absolute Neutrophil Count to Recover
Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).
Measured: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
Time to Resolution of Cytopenias: Platelet Transfusion Independence
Average number of days per patient for resolution of cytopenias.
Measured: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
Number of patients who died due to transplant related toxicities
Measured: up to 2 years after stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2008
Why it stopped: Treatment ineffective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Nelson, MD, Principal investigator, Indiana Universtiy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594308
- Sponsor's protocol ID
- 0705-20 IUCRO-0196
- Status last verified
- Sep 2014
- First submitted
- 4 Jan 2008
- Last updated
- 6 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Activated T-Cell Depletion to Prevent GVHD
- ClinicalTrials.gov ID
- NCT00594308
- Acronym / sponsor ID
- 0705-20 IUCRO-0196
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Lymphoma, Non-Hodgkin's
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment ineffective
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 20 Mar 2012
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 this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.
This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol
- Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.
Key exclusion criteria (7 listed)
- Active CNS disease (the presence of leukemic blasts in the CSF)
- Pregnancy or breast-feeding
- SGOT >3x upper limit of normal
- Creatinine >2 or creatinine clearance <50cc/hr.
- Fractional shortening by echocardiogram not within normal limits per institution
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 |
|---|---|---|
| Cyclophosphamide60mg/kg/day for two consecutive days (-7,-6). | Drug | – |
| Fludarabine25mg/m2/day for 5 consecutive days | Drug | – |
| Cyclosporine3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1. | Drug | – |
| Mycophenolate mofetil1000 mg will be administered through day +60 and then discontinued if there is no GVHD. | Drug | – |
| Basiliximab20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment. | Drug | – |
Primary outcome
Number of Patients With Acute Grade II-IV GVHD
Time frame: until 30 days after stem cell transplant
Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
4 secondary outcomes
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
Time frame: until 30 days after stem cell transplant
Number of Days for Absolute Neutrophil Count to Recover
Time frame: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
Time to Resolution of Cytopenias: Platelet Transfusion Independence
Time frame: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
Time frame: up to 2 years after stem cell transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Nelson, MD principal investigator
Indiana Universtiy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophosphamide, Fludarabine and Cyclosporine in people with Acute Myelogenous Leukemia and Acute Lymphocytic Leukemia, run by Indiana 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 2 inclusion and 7 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 6 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Acute Grade II-IV GVHD (time frame: until 30 days after stem cell transplant). 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 6 Oct 2014.