Acute Myeloid LeukemiaPhase 2NCT01720264
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
A Phase 2 study testing Sitagliptin in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Sherif S. Farag at 2 sites in United States.
Trial summary
The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2012to 15 Dec 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have one of the following disease types:
- Acute myeloid leukemia (AML) with disease features as described in the protocol.
- Acute lymphoblastic leukemia (ALL) with disease features as described in the protocol.
- Myelodysplasia with disease features as described in the protocol.
- Chronic myelogenous leukemia (CML) with disease features as described in the protocol.
- Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the disease features as described in the protocol.
Show all 15Show fewer
- At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy.
- For patients in remission, there should be no readily available consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1.
- No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1).
- Patients must have a matched or partially matched UCB unit with >/= 2.5 x10^7 nucleated cells/kg of recipient weight at the time of cryopreservation.
- No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms).
- No HIV disease.
- Non pregnant and non-nursing.
- Required baseline laboratory values as described in the protocol.
- Signed written informed consent.
Who cannot join
- Symptomatic uncontrolled coronary artery disease or congestive heart failure.
- Severe hypoxemia with room air PaO2<70, supplemental oxygen dependence, or DLCO<50% predicted.
- Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy.
- Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months.
- Patients who are taking other insulin secretagogues and/or insulin.
- Patients who have hypersensitivity to sitagliptin.
- Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (> 2 x ULN).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial
Valhalla, New York, 10595
About this study
Official title: A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).
Read the detailed description
Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being used in adults more often. However, because adults are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia, Leukemia, Myelogenous, Chronic, Lymphoma, Non-Hodgkin
- Being tested
- Sitagliptin
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3. Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent of Subjects Engrafting by Day +30 After Transplantation
Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.
Measured: Day 0 to Day +30 post transplant
Secondary outcomes (3)
Time to Neutrophil Engraftment
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Measured: Transplant (Day 0) up to 1 year
Time to Platelet Engraftment
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of three consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Measured: Transplant (Day 0) up to 1 year
Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Measured: Day 0 up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study start2 Nov 2012
- Primary completion27 Aug 2016
- Study completion15 Dec 2017
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 Myeloid 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif S. Farag
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Sherif S. Farag, Indiana University
- Investigators
- Sherif S Farag, MBBS, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720264
- Sponsor's protocol ID
- 1208009261; HL112669
- Other IDs
- 1R01HL112669-01
- Status last verified
- Dec 2018
- First submitted
- 30 Oct 2012
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT01720264
- Acronym / sponsor ID
- 1208009261; HL112669
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia, Leukemia, Myelogenous, Chronic, Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sherif S. FaragUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Nov 2012 (actual)
- Primary completion
- 27 Aug 2016 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).
Detailed description
Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being used in adults more often. However, because adults are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinSitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Patients must have one of the following disease types:
- At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy.
- For patients in remission, there should be no readily available consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1.
- No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1).
- Patients must have a matched or partially matched UCB unit with >/= 2.5 x10^7 nucleated cells/kg of recipient weight at the time of cryopreservation.
Key exclusion criteria (7 listed)
- Symptomatic uncontrolled coronary artery disease or congestive heart failure.
- Severe hypoxemia with room air PaO2<70, supplemental oxygen dependence, or DLCO<50% predicted.
- Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy.
- Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months.
- Patients who are taking other insulin secretagogues and/or insulin.
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 |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3. | Drug | Sitagliptin |
Primary outcome
The Percent of Subjects Engrafting by Day +30 After Transplantation
Time frame: Day 0 to Day +30 post transplant
Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.
3 secondary outcomes
Time to Neutrophil Engraftment
Time frame: Transplant (Day 0) up to 1 year
Time to Platelet Engraftment
Time frame: Transplant (Day 0) up to 1 year
Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities
Time frame: Day 0 up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- 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.
Sherif S Farag, MBBS, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitagliptin in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Sherif S. Farag at 2 sites 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 15 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: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 8 Jan 2019). 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?
The Percent of Subjects Engrafting by Day +30 After Transplantation (time frame: Day 0 to Day +30 post 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 8 Jan 2019.