Cutaneous T-Cell Lymphoma (Mycosis Fungoides)Phase 4MF99NCT00630903
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
A Phase 4 study testing PUVA (8MOP + UVA) + IFN and PUVA (8-MOP + UVA) in people with Cutaneous T-Cell Lymphoma (Mycosis Fungoides), run by Madrilenian Group of Cutaneous Lymphomas at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
- What is being tested?
- PUVA (8MOP + UVA) + IFN and PUVA (8-MOP + UVA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 9 sitesSpain
- Study dates
- Jan 2000to Jan 2003
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mycosis fungoides Stage Ia Ib IIa
- Written informed consent
- 18-70 y.o., both sex
- No concomitant systemic disease
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Príncipe de Asturias.
Alcalá de Henares, Madrid
Hospital Universitario de Getafe
Getafe, Madrid
Hospital de la Princess
Madrid, Madrid, 28009
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Fundación Jiménez Díaz
Madrid, Madrid
Hospital Clínico San Carlos
Madrid, Madrid
Hospital Gómez Ulla
Madrid, Madrid
Hospital La Paz
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
About this study
Official title: Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
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.
- Being tested
- PUVA (8MOP + UVA) + IFN, PUVA (8-MOP + UVA)
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUVA (8MOP + UVA) + IFNDrug
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)
PUVA (8-MOP + UVA)Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 8-MOP + UVA x 24 weeks Receives: Drug: PUVA (8-MOP + UVA) |
| B | Active comparator | IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks Receives: Drug: PUVA (8MOP + UVA) + IFN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PUVA vs PUVA + IFN
Measured: Weeks 4, 8, 12, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2000
- Primary completionJan 2003 (estimated)
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous T-Cell Lymphoma (Mycosis Fungoides)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrilenian Group of Cutaneous Lymphomas
- Sponsor type
- University, hospital or other
- Investigators
- Francisco Vanaclocha Sebastián, MD, Principal investigator, Hospital 12 de OctubreJesús Fernández Herrera, MD, PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630903
- Sponsor's protocol ID
- MF99
- Acronym
- MF99
- Status last verified
- Feb 2008
- First submitted
- 28 Feb 2008
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32632956