A Phase II Study of Doxycycline in Relapsed NHL

NCT02086591 | Terminated Phase 2 Results DMC

• 2 other identifiers: 50370120145
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether doxycycline is effective in the treatment of relapsed Non Hodgkin Lymphomas (NHL).

Conditions

Adult Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma Recurrent; Lymphoma, Follicular; Marginal Zone B-Cell Lymphoma; Malignant Lymphoma - Lymphoplasmacytic; Waldenstrom Macroglobulinemia; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia (CLL); T-Cell Lymphoma

Keywords

Non Hodgkin Lymphoma; Doxycycline

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as: * Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography * ≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node \>1 cm in its short axis from nadir. * To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis. * At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.

  Three months

Secondary Outcomes (1)

• Percentage of Patients With Progression Free Survival

  One year

Other Outcomes (1)

• Exploratory Objective

  One year

Study Arms (1)

Doxycycline

EXPERIMENTAL

Doxycycline 200 mg twice daily

Drug: Doxycycline

Interventions

Doxycycline DRUG

Doxycycline

Eligibility Criteria

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

You may qualify if:

• Relapsed aggressive or indolent NHL following any prior treatment of the following etiologies:
• Diffuse large B cell lymphoma (DLBCL)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma (FL)
• Marginal zone lymphoma (MZL)
• Lymphoplasmacytic lymphoma (LPL)
• Waldenstrom's macroglobulinemia (WM)
• Small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukemia (CLL)
• T cell lymphoma (TCL)
• Ages ≥ 18
• Karnofsky Performance Status (KPS) ≥ 60% or Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2
• Life expectancy of at least 3 months
• Measurable disease in at least one target lesion, assessable by radiographic examination with Fludeoxyglucose-Positron Emission Tomography (FDG-PET) or computed tomography (CT), bone marrow evaluation showing involvement, or peripheral blood showing involvement of lymphoma
• Adequate organ function:

You may not qualify if:

• Known sensitivity or allergy to tetracyclines
• Lack of measurable disease by computed tomography (CT) or Fludeoxyglucose-Positron Emission Tomography (FDG-PET)
• Karnofsky Performance Status (KPS) \<60% or Eastern Cooperative Oncology Group Performance Status (ECOG PS) \>2
• Curative treatment is indicated or possible
• Inadequate organ function as measured by not fulfilling above criteria
• Pregnancy, positive serum human chorionic gonadotropin (hCG) within 28 days of enrollment, or breast-feeding.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Carla Casulo
• Organization: University of Rochester

carla_casulo@urmc.rochester.edu

585-273-3258

Study Officials

• Carla Casulo, MD

  University of Rochester

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 22, 2016
• Results First Posted: December 22, 2016

Record last verified: 2016-10

Locations

US (1)