Pasireotide in Prevention of GI Toxicity

NCT02215070 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00051736
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.

Conditions

Hematological Malignancies

Keywords

Allogeneic Stem Cell Transplantation; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Acute Non-Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Myeloid Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide

  Number of participants who experience grades III-IV GI toxicity

  30 Days

Secondary Outcomes (6)

• Percentage of Acute GVHD

  100 days

• Maximum Severity of Acute GVHD Compared to Historical Controls

  100 days

• Incidence of Chronic GVHD Compared to Historical Controls

  1 year

• Maximum Severity of Chronic GVHD Compared to Historical Controls

  1 year

• Overall Survival Compared to Historical Controls

  1 year

Other Outcomes (2)

• Citrulline and Fecal Calprotectin Levels Will be Measured

  100 days

• Evaluate GI Toxicity Assessment by Video Capsule Endoscopy.

  14 days

Study Arms (1)

Pasireotide + Preparatory Regimen

EXPERIMENTAL

Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.

Drug: Pasireotide

Interventions

Pasireotide DRUG

Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.

Pasireotide + Preparatory Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at the time of study enrollment.
• Histologically confirmed diagnosis for which an allogeneic transplant is utilized.
• Plan to receive an allogeneic transplant from a 4-6/6 single or dual umbilical cord blood graft, or a 7-8/8 HLA-matched sibling or unrelated donor (High resolution HLA-A, B, C, DRB1).
• Meet standard criteria as defined by the institution for a myeloablative allogeneic stem cell transplantation, with myeloablative defined as using conditioning regimens containing:
• TBI ≥ 1200 cGy, or
• Busulfan ≥ 12.8mg/kg
• Patient must have given written informed consent according to FDA guidelines.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

You may not qualify if:

• Female patients who are pregnant or lactating, or are of childbearing potential (FCBP, defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control
• FCBP must have a current negative serum pregnancy test prior to transplant per institutional practice.
• Use of an investigational drug within 1 month prior to dosing. Concurrent enrollment on other clinical research studies that contain an interventional therapy is not permitted while subjects are receiving pasireotide or within 5 half-lives of finishing pasireotide. However, subjects may concurrently enroll in non-interventional studies (e.g. biobanking, mobile health tracking).
• Active CNS disease (related to primary malignancy) at the time of enrollment.
• Patients with existing grade 2 toxicities, except as approved by the investigator.
• Any of the following diseases or conditions:
• Cardiac:
• History of unexplained syncope or family history of idiopathic sudden death.
• Sustained or clinically significant cardiac arrhythmias.
• Risk factors for Torsades de Pointes such as:
• Uncontrolled hypokalemia
• Uncontrolled hypomagnesemia or hypermagnesemia
• Cardiac failure (New York Heart Association Class II or higher)
• Clinically significant/symptomatic bradycardia (HR \< 50), or high-grade AV block.
• Known diagnosis of QT prolongation (QTc ≥ 470) or family history of long QT syndrome

Sponsors & Collaborators

• Anthony Sung, MD: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

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

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; 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

Results Point of Contact

• Title: Anthony Sung
• Organization: Duke University

anthony.sung@duke.edu

919-668-1000

Study Officials

• Anthony Sung, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Professor of Medicine

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: January 21, 2015
• Primary Completion: February 28, 2019
• Study Completion: October 15, 2019
• Last Updated: November 17, 2021
• Results First Posted: March 11, 2020

Record last verified: 2021-10

Locations

US (2)