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PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides (MF99)

Primary Purpose

Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
PUVA (8MOP + UVA) + IFN
PUVA (8-MOP + UVA)
Sponsored by
Madrilenian Group of Cutaneous Lymphomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mycosis fungoides Stage Ia Ib IIa
  • Written informed consent
  • 18-70 y.o., both sex
  • No concomitant systemic disease

Exclusion Criteria:

  • Pregnant or lactating women
  • Fertile women not accepting contraception
  • Medical history of melanoma or non melanoma skin cancer
  • Concomitant infections
  • Immunodeficiency states
  • Previous Heart disease
  • Respiratory insufficiency
  • Chronic RRenal insufficiency
  • Chronic hepatopathy
  • Epilepsy
  • Depression
  • Leucocytes <3000 or neutrophiles <1000 or thrombocytes <100000 or hemoglobin <12 gr/dL or ANA <1/80
  • Treatment with systemic steroids
  • Altered thyroid hormones
  • Previous resistance to PUVA and/or IFN
  • Hypersensitivity to IFN
  • Patients under treatment with teophiline and/or dicumarol
  • Previous total skin electron beam
  • Wash up period less than 3 month for IFN and /or PUVA
  • Wash up period less than 1 month for topical treatments

Sites / Locations

  • Hospital Príncipe de Asturias.
  • Hospital Universitario de Getafe
  • Hospital de la Princess
  • Hospital Universitario 12 de Octubre
  • Fundación Jiménez Díaz
  • Hospital Clínico San Carlos
  • Hospital Gómez Ulla
  • Hospital La Paz
  • Hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

8-MOP + UVA x 24 weeks

IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks

Outcomes

Primary Outcome Measures

Efficacy of PUVA vs PUVA + IFN

Secondary Outcome Measures

Full Information

First Posted
February 28, 2008
Last Updated
March 6, 2008
Sponsor
Madrilenian Group of Cutaneous Lymphomas
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1. Study Identification

Unique Protocol Identification Number
NCT00630903
Brief Title
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
Acronym
MF99
Official Title
Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual
Study Start Date
January 2000 (undefined)
Primary Completion Date
January 2003 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Madrilenian Group of Cutaneous Lymphomas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
8-MOP + UVA x 24 weeks
Arm Title
B
Arm Type
Active Comparator
Arm Description
IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
Intervention Type
Drug
Intervention Name(s)
PUVA (8MOP + UVA) + IFN
Intervention Description
Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)
Intervention Type
Drug
Intervention Name(s)
PUVA (8-MOP + UVA)
Intervention Description
Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)
Primary Outcome Measure Information:
Title
Efficacy of PUVA vs PUVA + IFN
Time Frame
Weeks 4, 8, 12, 16 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mycosis fungoides Stage Ia Ib IIa Written informed consent 18-70 y.o., both sex No concomitant systemic disease Exclusion Criteria: Pregnant or lactating women Fertile women not accepting contraception Medical history of melanoma or non melanoma skin cancer Concomitant infections Immunodeficiency states Previous Heart disease Respiratory insufficiency Chronic RRenal insufficiency Chronic hepatopathy Epilepsy Depression Leucocytes <3000 or neutrophiles <1000 or thrombocytes <100000 or hemoglobin <12 gr/dL or ANA <1/80 Treatment with systemic steroids Altered thyroid hormones Previous resistance to PUVA and/or IFN Hypersensitivity to IFN Patients under treatment with teophiline and/or dicumarol Previous total skin electron beam Wash up period less than 3 month for IFN and /or PUVA Wash up period less than 1 month for topical treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Vanaclocha Sebastián, MD
Organizational Affiliation
Hospital 12 de Octubre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesús Fernández Herrera, MD, PhD
Organizational Affiliation
Hospital de la Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Príncipe de Asturias.
City
Alcalá de Henares
State/Province
Madrid
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
State/Province
Madrid
Country
Spain
Facility Name
Hospital de la Princess
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Gómez Ulla
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32632956
Citation
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Results Reference
derived

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PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides

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