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Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

NCT02106650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-11-20

No results posted yet for this study

Summary

This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

Conditions

  • Relapsed Peripheral T-Cell Lymphoma
  • Refractory Peripheral T-Cell Lymphoma

Interventions

DRUG

Folotyn and Leucovorin

DRUG

Folic Acid

Folic acid (1.0 mg PO QD) is to be initiated at least 10 days prior to Folotyn administration, or per the USPI for Folotyn.

DRUG

Vitamin B12

Vitamin B12 (1 mg IM) is to be administered within 10 weeks prior to initiation of Folotyn and can be administered during Screening. Subsequent vitamin B12 injections may be given the same day as treatment with Folotyn and patients are to receive vitamin B12 every 8 to 10 weeks while treated with Folotyn.

Sponsors & Collaborators

  • Axis Clinicals Limited

    collaborator INDUSTRY

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Wasim Khan, MD · Acrotech Biopharma Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-10-31
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02106650 on ClinicalTrials.gov