Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant

NCT01720264 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1208009261; HL1126691R01HL112669-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Hematopoetic Myelodysplasia; Leukemia, Myelogenous, Chronic; Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 to Day +30 post transplant

Secondary Outcomes (3)

• Time to Neutrophil Engraftment

  Transplant (Day 0) up to 1 year

• Time to Platelet Engraftment

  Transplant (Day 0) up to 1 year

• Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities

  Day 0 up to 3 years

Study Arms (1)

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.

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

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.

Also known as: Januvia

Sitagliptin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sherif S. Farag: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Non-Hodgkin

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Sherif Farag
• Organization: IndianaU

ssfarag@iu.edu

(317) 278-0460

Study Officials

• Sherif S Farag, MBBS, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lawrence H. Einhorn Professor of Oncology

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 2, 2012
• Study Start: November 2, 2012
• Primary Completion: August 27, 2016
• Study Completion: December 15, 2017
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Locations

US (2)