Acute Myelogenous LeukemiaPhase 3CICLODECHNCT01749111
Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
A Phase 3 study testing ARM A Cyclophosphamide and ARM B Calcineurin inhibitor and methotrexate in people with Acute Myelogenous Leukemia and Acute Lymphoid Leukemia, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Myeloproliferative Disease
- What is being tested?
- ARM A Cyclophosphamide and ARM B Calcineurin inhibitor and methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Aug 2016
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Man or woman 18 to 60 years of age.
- The patient should have a HLA matched donor
- The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease)
- Patients want to participate in the study, and able to give informed consent.
Who cannot join
- Previous auto o allogeneic hematopoietic stem cell transplant
- Performance Status >2 (ECOG).
- Pregnancy
- HIV positive
- Active Infection
- Cardiac disease with ejection fraction < 45%
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- Lung disease with FEV1, FVC ou DLCO <50% of predicted values.
- Renal Insufficiency with creatinine clearance < 60 ml/minute.
- Liver disease with bilirubin levels > twice the reference value or ALT or AST > three times the normal reference.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
São Paulo, São Paulo, 05652-000
About this study
Official title: Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor
Read the detailed description
We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Myeloproliferative Disease, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- Being tested
- ARM A Cyclophosphamide, ARM B Calcineurin inhibitor and methotrexate
- Keywords
- bone marrow transplantation, graft versus host disease, Acute myelogenous leukemia, Acute lymphoid leukemia, Myeloproliferative disease, Myelodysplastic syndrome, Chronic myeloid leukemia, chronic myelomonocytic leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myeloproliferative Disorders, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myelomonocytic, Chronic, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARM A CyclophosphamideDrug
Also called Cyclophosphamide
Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
ARM B Calcineurin inhibitor and methotrexateDrug
Also called Calcineurin inhibitor and methotrexate
Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4 Receives: Drug: ARM A Cyclophosphamide |
| Arm B | Active comparator | In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis Receives: Drug: ARM B Calcineurin inhibitor and methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
Measured: one year
Secondary outcomes (1)
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Vidal Campregher, Hospital Israelita Albert Einstein
- Investigators
- Paulo V Campregher, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749111
- Sponsor's protocol ID
- GEDECH-2012
- Acronym
- CICLODECH
- Status last verified
- Mar 2017
- First submitted
- 11 Dec 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2.
PubMed 20124511
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
- ClinicalTrials.gov ID
- NCT01749111
- Acronym / sponsor ID
- CICLODECH / GEDECH-2012
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Myeloproliferative Disease, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- Keywords
- bone marrow transplantation, graft versus host disease, Acute myelogenous leukemia, Acute lymphoid leukemia, Myeloproliferative disease, Myelodysplastic syndrome, Chronic myeloid leukemia, chronic myelomonocytic leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Dec 2012 (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 this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor
Detailed description
We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: ARM A CyclophosphamideGraft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4 |
| Arm B | Active comparator | Drug: ARM B Calcineurin inhibitor and methotrexateIn this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Man or woman 18 to 60 years of age.
- The patient should have a HLA matched donor
- The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease)
- Patients want to participate in the study, and able to give informed consent.
Key exclusion criteria (9 listed)
- Previous auto o allogeneic hematopoietic stem cell transplant
- Performance Status >2 (ECOG).
- Pregnancy
- HIV positive
- Active Infection
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 |
|---|---|---|
| ARM A CyclophosphamideAlso: CyclophosphamideCyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation | Drug | Arm A |
| ARM B Calcineurin inhibitor and methotrexateAlso: Calcineurin inhibitor and methotrexateGraft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate | Drug | Arm B |
Primary outcome
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
Time frame: one year
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
1 secondary outcome
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Time frame: one year
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 20124511Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2.
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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.
Paulo V Campregher, MD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARM A Cyclophosphamide and ARM B Calcineurin inhibitor and methotrexate in people with Acute Myelogenous Leukemia and Acute Lymphoid Leukemia, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 4 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 3 Mar 2017. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of accrual). 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?
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01749111, which also lists 1 linked publication.
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 3 Mar 2017.