Hematological MalignanciesPhase 2NCT01246206
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
A Phase 2 study testing Tacrolimus and Thymoglobulin in people with Hematological Malignancies, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Tacrolimus and Thymoglobulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable related donor as determined by the treating physician
- High resolution molecular HLA typing is mandatory for HLA Class I and II
- Diagnosis of hematological malignancy
- Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol:
- Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR)
- Hodgkin disease, any CR/PR/stable disease (SD)
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- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/μl on the day of initiation of conditioning
- Myelodysplastic syndrome (MDS), treated or untreated
- Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase
- Chronic myelomonocytic leukemia (CMML)
- Multiple myeloma, any CR/PR/SD
- Chronic lymphocytic leukemia (CLL) any CR/PR
- Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning
- Age >= 18 and able to cooperate with oral medication intake
- Filgrastim (G-CSF) mobilized Peripheral blood stem cells
- Agrees to participate, and informed consent signed
- Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Creatinine clearance > 60 mL/min
- Ejection fraction > 50%
- Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
- Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted
Who cannot join
- Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc)
- Patients with documented uncontrolled central nervous system (CNS) disease
- Active donor or recipient serology positive for human immunodeficiency virus (HIV)
- Known contraindication to administration of Tacrolimus or Thymoglobulin
- Active Hepatitis B or C
- Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator
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- Oxygen usage at the time of enrollment
- Patients with clinical ascites
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.
- Conditions
- Hematological Malignancies
- Being tested
- Tacrolimus and Thymoglobulin
- Keywords
- ● Non-Hodgkin lymphoma,, ● Hodgkin disease,, ● Acute Myelogenous or Acute Lymphocytic Leukemia, ● Myelodysplastic Syndromes,, ● Chronic Myelogenous Leukemia, ● Multiple Myeloma, ● Chronic Lymphocytic Leukemia, ● Myelofibrosis and other myeloproliferative disorders;
- Medical subject headings
- Hematologic Neoplasms, Lymphoma, Non-Hodgkin, Hodgkin Disease, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus and ThymoglobulinDrug
Also called PROGRAF®
Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus and Thymoglobulin | Experimental | Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Receives: Drug: Tacrolimus and Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute GVHD
Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
Measured: Assessed first 6 months post transplant
Safety Defined by Serious Adverse Events
Counted the number of participants that experienced any type of grade 3 or higher toxicity.
Measured: Assessed first 6 months post transplant
Severity of Acute GVHD
Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
Measured: Assessed first 6 months post transplant
Secondary outcomes (5)
Determine Incidence of Opportunistic Infections
Measured: Followed for up to two years post transplant
Estimate Incidence of Chronic GVHD at Two Years
Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks
Measured: Followed for up to two years post transplant
Overall Survival at Two Year,
Measured: Followed for up to two years post transplant
Determine Time to Engraftment ("G500")
The number of days until engraftment ("G500")
Measured: Followed for up to two years post transplant
Determine Time to Engraftment ("PLT20")
The number of days until engraftment ("PLT20")
Measured: Followed for up to two years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionOct 2013
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 Hematological MalignanciesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute
- Investigators
- Zaid Al-Kadhimi, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246206
- Sponsor's protocol ID
- WSU 2009-095
- Status last verified
- May 2018
- First submitted
- 21 Nov 2010
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT01246206
- Acronym / sponsor ID
- WSU 2009-095
- Conditions
- Hematological Malignancies
- Keywords
- ● Non-Hodgkin lymphoma,, ● Hodgkin disease,, ● Acute Myelogenous or Acute Lymphocytic Leukemia, ● Myelodysplastic Syndromes,, ● Chronic Myelogenous Leukemia, ● Multiple Myeloma, ● Chronic Lymphocytic Leukemia, ● Myelofibrosis and other myeloproliferative disorders;
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus and Thymoglobulin | Experimental | Drug: Tacrolimus and ThymoglobulinTacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Suitable related donor as determined by the treating physician
- High resolution molecular HLA typing is mandatory for HLA Class I and II
- Diagnosis of hematological malignancy
- Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol:
- Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR)
Key exclusion criteria (9 listed)
- Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc)
- Patients with documented uncontrolled central nervous system (CNS) disease
- Active donor or recipient serology positive for human immunodeficiency virus (HIV)
- Known contraindication to administration of Tacrolimus or Thymoglobulin
- Active Hepatitis B or C
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 |
|---|---|---|
| Tacrolimus and ThymoglobulinAlso: PROGRAF®Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours. | Drug | Tacrolimus and Thymoglobulin |
Primary outcome
Incidence of Acute GVHD
Time frame: Assessed first 6 months post transplant
Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
Safety Defined by Serious Adverse Events
Time frame: Assessed first 6 months post transplant
Counted the number of participants that experienced any type of grade 3 or higher toxicity.
Severity of Acute GVHD
Time frame: Assessed first 6 months post transplant
Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
5 secondary outcomes
Determine Incidence of Opportunistic Infections
Time frame: Followed for up to two years post transplant
Estimate Incidence of Chronic GVHD at Two Years
Time frame: Followed for up to two years post transplant
Overall Survival at Two Year,
Time frame: Followed for up to two years post transplant
Determine Time to Engraftment ("G500")
Time frame: Followed for up to two years post transplant
Determine Time to Engraftment ("PLT20")
Time frame: Followed for up to two years post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- 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, M.D. principal investigator
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 Tacrolimus and Thymoglobulin in people with Hematological Malignancies, 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?
The sponsor lists 21 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: finished, as of the sponsor's last update on 18 Jun 2018. 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 1 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 GVHD (time frame: Assessed first 6 months post transplant). 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 18 Jun 2018.