Who is sponsoring NCT00168064?

NCT00168064 is sponsored by Yaupon Therapeutics.

What drugs are being tested in NCT00168064?

Interventions in NCT00168064: mechlorethamine-MCH (nitrogen mustard).

What condition does NCT00168064 study?

NCT00168064 studies Mycosis Fungoides.

Is NCT00168064 still recruiting?

NCT00168064 is currently completed. Last updated 2 October 2012.

Are results published for NCT00168064?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-10-02 · How we verify

NCT00168064

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

Completed Phase 2 Results posted Last updated 2 October 2012

What this trial tests

Phase 2 trial testing mechlorethamine-MCH (nitrogen mustard) in Mycosis Fungoides in 260 participants. Completed in 1 August 2011.

Timeline

1 May 2006

Primary endpoint
1 August 2010

1 August 2011

Quick facts

Lead sponsor	Yaupon Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	260
Start date	1 May 2006
Primary completion	1 August 2010
Estimated completion	1 August 2011
Sites	12 locations across United States

Drugs / interventions tested

mechlorethamine-MCH (nitrogen mustard) — full drug profile →

Conditions studied

Mycosis Fungoides — all drugs for Mycosis Fungoides →

Sponsor

Yaupon Therapeutics — full company profile →

Who can join

Eligibility, any sex, with Mycosis Fungoides. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Ratio of Response Rates Based on CAILS
Time frame: Assessment made at Day 1 and every subsequent visit during treatment
The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment

Sponsor's own description

This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides.
Lessin SR, Duvic M, Guitart J, Pandya AG, et al · · 2013 · cited 128× · PMID 23069814 · DOI 10.1001/2013.jamadermatol.541
Lack of Systemic Absorption of Topical Mechlorethamine Gel in Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma.
Querfeld C, Geskin LJ, Kim EJ, Scarisbrick JJ, et al · · 2021 · cited 22× · PMID 33347924 · DOI 10.1016/j.jid.2020.12.009
Interventions for mycosis fungoides.
Valipour A, Jäger M, Wu P, Schmitt J, et al · · 2020 · cited 17× · PMID 32632956 · DOI 10.1002/14651858.cd008946.pub3
Chlormethine Gel in Combination with Other Therapies in the Treatment of Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: Three Case Reports.
Lampadaki K, Koumourtzis M, Karagianni F, Marinos L, et al · · 2021 · cited 14× · PMID 33928511 · DOI 10.1007/s12325-021-01721-x
Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides.
Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, et al · · 2022 · cited 11× · PMID 34091453 · DOI 10.1159/000516138
Chlormethine Gel for Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: A Review of Efficacy and Safety in Clinical Trial and Real-World Settings.
Wehkamp U, Ardigò M, Papadavid E, Querfeld C, et al · · 2022 · cited 10× · PMID 35852707 · DOI 10.1007/s12325-022-02219-w
Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data.
Querfeld C, Scarisbrick JJ, Assaf C, Kim YH, et al · · 2022 · cited 6× · PMID 35536441 · DOI 10.1007/s40257-022-00687-y
Chlormethine Gel for the Treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing.
Giuliano C, Frizzarin S, Alonzi A, Stimamiglio V, et al · · 2022 · cited 4× · PMID 36229764 · DOI 10.1007/s13555-022-00813-y

Verify or expand the search:

Other recruiting trials for Mycosis Fungoides

Currently open trials in the same condition.

NCT07055477 — A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T- · Phase 1 · recruiting
NCT06716658 — JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas · Phase 2 · recruiting
NCT06207812 — Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis · recruiting
NCT05944562 — Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome · Phase 1 · active not recruiting
NCT06508463 — Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00168064 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yaupon Therapeutics
Last refreshed: 2 October 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00168064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing