Chronic Myeloproliferative DisordersPhase 2NCT00691015
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
A Phase 2 study testing rituximab, busulfan and carmustine in people with Chronic Myeloproliferative Disorders and Leukemia, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- rituximab, busulfan and carmustine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Apr 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of a hematological malignancy, including any of the following:
- Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)
- Hodgkin lymphoma in CR or PR
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either of the following criteria:
- In CR
- Not in CR and meets the following criteria:
- Bone marrow blast < 20% within 4 weeks of transplantation
- Peripheral blood absolute blast count < 500 per microliter on the day of initiating conditioning therapy
- Myelodysplastic syndromes, treated or untreated
- Chronic myeloid leukemia in chronic phase or accelerated phase
- Multiple myeloma in CR or PR
- Chronic lymphocytic leukemia in second or greater CR or PR
- Myelofibrosis or other myeloproliferative disorders meeting the following criteria:
- Bone marrow blasts < 20% within 4 weeks of transplantation
- Peripheral blood absolute blast count < 500 per microliter on the day of initiating conditioning therapy
- Patients with ascites not allowed
- No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+ enrichment, T-cell depletion, etc)
- Scheduled to undergo peripheral blood stem cell transplantation from a suitable HLA-matched or -mismatched unrelated donor, as determined by treating physician
- High resolution molecular HLA typing is required for HLA class I and II
- No more than one antigen or allele mismatch
- No documented uncontrolled CNS disease
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2
- Karnofsky PS 60-100%
- Creatinine clearance > 50 mL/min
- Bilirubin < 3 times upper limit of normal (ULN)
- ALT and AST < 3 times ULN
- LVEF > 50%
- FVC, FEV_1, or DLCO > 50% predicted
- Patients on home oxygen not allowed
- Able to cooperate with oral medication intake
- HIV negative
- No active hepatitis B or hepatitis C
- No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- To determine the incidence and severity of acute graft-versus-host disease (GVHD) after HLA-matched or -mismatched unrelated donor peripheral blood stem cell transplantation (PBSCT) in patients with hematologic malignancies treated with immunosuppressive therapy comprising sirolimus, tacrolimus, and anti-thymocyte globulin as GVHD prophylaxis.
- To determine the safety of this regimen in these patients at 6 months after PBSCT.
Secondary
- To determine the time to engraftment (i.e., platelet and absolute neutrophil recovery) in patients treated with this regimen.
- To determine the length of hospital stay of these patients within 100 days after PBSCT.
- To determine the incidence of infections, including CMV and EBV reactivation and post-transplant lymphoproliferative disorders, in patients treated with this regimen.
- To determine the incidence of thrombotic microangiopathy and veno-occlusive disease in patients treated with this regimen.
- To determine the incidence of chronic GVHD in patients treated with this regimen.
- To determine the overall and disease-free survival of these patients at 2 years after PBSCT.
- To determine the Karnofsky performance status of these patients at baseline and at various time points after PBSCT.
- To conduct immunocorrelative studies prior to and at various time points after PBSCT.
OUTLINE:
- Conditioning regimen: Patients receive 1 of 6 conditioning regimens (standard of care treatment) between days -9 and -3, based on diagnosis and the treating physician's preference regarding regimen intensity.
- Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.
- Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.
- Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.
- Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.
- Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.
- Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI.
- Allogeneic peripheral blood stem cell transplantation: Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
- Graft-versus-host disease prophylaxis (GVHD): Patients receive tacrolimus IV continuously over 24 hours or orally and sirolimus orally beginning on day -3 and continuing until day 30 or day 90, followed by a taper in the absence of GVHD. Patients also receive anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
Blood samples are obtained at baseline and periodically during study for correlative biomarker studies. Samples are analyzed by T-cell immunophenotyping, absolute subset number quantification, and multi-parameter flow cytometry for evaluation of immune reconstitution, T-cell differentiation status, NK-cell recovery, allo-reactivity of donor T-cells after transplantation, and regulatory T-cell reconstitution.
After completion of study therapy, patients are followed periodically for up to 2 years.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- rituximab, busulfan, carmustine, cyclophosphamide, cytarabine
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Also called Rituxan, MabThera, Zytux
Given IV
busulfanDrug
Also called Busulfex, Myleran
Given IV
carmustineDrug
Also called Bicnu, Gliadel
Given IV
cyclophosphamideDrug
Also called Cytoxan, Cytoxan Lyophilized, Neosar
Given IV
cytarabineDrug
Also called Depocyt
Given IV
etoposideDrug
Also called Etopophos, Toposar
Given IV
Also called Fludara®
Given IV
melphalanDrug
Also called Alkeran
Given IV
total body irradiation (TBI)Radiation
Also called radiotherapy
Given once or twice daily
anti-thymocyte globulin IVDrug
Also called Thymoglobulin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy or chemotherapy + total body irradiation | Experimental | Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:
Regimen I: Patients receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV.
Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV;anti-thymocyte globulin IV.
Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV; anti-thymocyte globulin IV.
Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV.
Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV; anti-thymocyte globulin IV.
Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI; anti-thymocyte globulin IV. Receives: Biological: rituximab; Drug: busulfan; Drug: carmustine; Drug: cyclophosphamide; Drug: cytarabine; Drug: etoposide; Drug: fludarabine phosphate; Drug: melphalan; Radiation: total body irradiation (TBI); Drug: anti-thymocyte globulin IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Graft-versus-host Disease (GVHD)
Measured: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
Severity of Acute Graft-versus-host Disease (GVHD)
Measured: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.
Measured: Within 6 months after PBSCT
Secondary outcomes (5)
Incidence of Chronic GVHD.
Measured: Within 2 years after PBSCT
Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )
Measured: post transplant, up to 4 weeks
Overall Survival.
Measured: At 2 years after PBSCT
Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)
Measured: Within 6 months after PBSCT
Karnofsky Performance Status Performance Status
100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs.
50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.
20 - Very sick; hospital admission necessary; active supportive treatment necessary.
10 - Moribund; fatal processes progressing rapidly. 0 - Dead
Measured: At 90 days after PBSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2014
- Study completionApr 2014
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 Chronic Myeloproliferative DisordersStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute
- Investigators
- Zaid Al-Kadhimi, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691015
- Sponsor's protocol ID
- 2007-127
- Other IDs
- P30CA022453, GENZ-WSU-2007-127, 2007-127
- Status last verified
- May 2017
- First submitted
- 4 Jun 2008
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT00691015
- Acronym / sponsor ID
- 2007-127
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- To determine the incidence and severity of acute graft-versus-host disease (GVHD) after HLA-matched or -mismatched unrelated donor peripheral blood stem cell transplantation (PBSCT) in patients with hematologic malignancies treated with immunosuppressive therapy comprising sirolimus, tacrolimus, and anti-thymocyte globulin as GVHD prophylaxis.
- To determine the safety of this regimen in these patients at 6 months after PBSCT.
Secondary
- To determine the time to engraftment (i.e., platelet and absolute neutrophil recovery) in patients treated with this regimen.
- To determine the length of hospital stay of these patients within 100 days after PBSCT.
- To determine the incidence of infections, including CMV and EBV reactivation and post-transplant lymphoproliferative disorders, in patients treated with this regimen.
- To determine the incidence of thrombotic microangiopathy and veno-occlusive disease in patients treated with this regimen.
- To determine the incidence of chronic GVHD in patients treated with this regimen.
- To determine the overall and disease-free survival of these patients at 2 years after PBSCT.
- To determine the Karnofsky performance status of these patients at baseline and at various time points after PBSCT.
- To conduct immunocorrelative studies prior to and at various time points after PBSCT.
OUTLINE:
- Conditioning regimen: Patients receive 1 of 6 conditioning regimens (standard of care treatment) between days -9 and -3, based on diagnosis and the treating physician's preference regarding regimen intensity.
- Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.
- Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.
- Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.
- Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.
- Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.
- Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI.
- Allogeneic peripheral blood stem cell transplantation: Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
- Graft-versus-host disease prophylaxis (GVHD): Patients receive tacrolimus IV continuously over 24 hours or orally and sirolimus orally beginning on day -3 and continuing until day 30 or day 90, followed by a taper in the absence of GVHD. Patients also receive anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
Blood samples are obtained at baseline and periodically during study for correlative biomarker studies. Samples are analyzed by T-cell immunophenotyping, absolute subset number quantification, and multi-parameter flow cytometry for evaluation of immune reconstitution, T-cell differentiation status, NK-cell recovery, allo-reactivity of donor T-cells after transplantation, and regulatory T-cell reconstitution.
After completion of study therapy, patients are followed periodically for up to 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy or chemotherapy + total body irradiation | Experimental | Biological: rituximab, Drug: busulfan, Drug: carmustine, Drug: cyclophosphamide, Drug: cytarabine, Drug: etoposide, Drug: fludarabine phosphate, Drug: melphalan, Radiation: total body irradiation (TBI), Drug: anti-thymocyte globulin IVStandard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV;anti-thymocyte globulin IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV; anti-thymocyte globulin IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV; anti-thymocyte globulin IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI; anti-thymocyte globulin IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| rituximabAlso: Rituxan, MabThera, ZytuxGiven IV | Biological | Chemotherapy or chemotherapy + total body irradiation |
| busulfanAlso: Busulfex, MyleranGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| carmustineAlso: Bicnu, GliadelGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| cyclophosphamideAlso: Cytoxan, Cytoxan Lyophilized, NeosarGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| cytarabineAlso: DepocytGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| etoposideAlso: Etopophos, ToposarGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| fludarabine phosphateAlso: Fludara®Given IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| melphalanAlso: AlkeranGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
| total body irradiation (TBI)Also: radiotherapyGiven once or twice daily | Radiation | Chemotherapy or chemotherapy + total body irradiation |
| anti-thymocyte globulin IVAlso: ThymoglobulinGiven IV | Drug | Chemotherapy or chemotherapy + total body irradiation |
Primary outcome
Incidence of Acute Graft-versus-host Disease (GVHD)
Time frame: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
Severity of Acute Graft-versus-host Disease (GVHD)
Time frame: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.
Time frame: Within 6 months after PBSCT
5 secondary outcomes
Incidence of Chronic GVHD.
Time frame: Within 2 years after PBSCT
Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )
Time frame: post transplant, up to 4 weeks
Overall Survival.
Time frame: At 2 years after PBSCT
Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)
Time frame: Within 6 months after PBSCT
Karnofsky Performance Status Performance Status
Time frame: At 90 days after PBSCT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- 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.
Zaid Al-Kadhimi, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, busulfan and carmustine in people with Chronic Myeloproliferative Disorders and Leukemia, run by Barbara Ann Karmanos Cancer Institute 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?
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 28 Jun 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). 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?
Incidence of Acute Graft-versus-host Disease (GVHD) (time frame: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria). The study lists 3 primary outcomes in all. 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 28 Jun 2017.