LymphomaPhase 1NCT01804335
CD5789 in Early Cutaneous T-Cell Lymphoma (CTCL)
A Phase 1 study testing CD5789 0.01% Cream in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if CD5789 is safe and tolerable when given to patients with early stage CTCL. CD5789 is designed to attach to tumor cells and change their genetic material. This may stop the growth of the tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- CD5789 0.01% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Subject is a male or female, who is at least 18 years of age at Screening visit.
- The Subject has a clinical diagnosis of stable CTCL early stage (IA-IIA). The subject has :a) A known stable TNMB stage (cancer classification based on analysis of Tumors, Nodes, Metastasis and Blood), or b) Stable patch or plaque lesions that have not responded to topical treatment with corticosteroids or nitrogen mustard or which have relapsed after prior therapy.
- The Subject presents at least 3 distinct lesions (one selected as index lesion, one dedicated to biopsy and another one dedicated to tape-stripping).
- If the Subject is a female of childbearing potential, she agrees to use a highly contraceptive method for the duration of the study and for one month after the last product application. A highly effective method of contraception is defined by: 1) Bilateral tubal ligation 2) Combined oral contraceptives (estrogen and progesterone) implanted or injectable contraceptives, on a stable dose for at least 1 month prior to screening visit, 3) Hormonal intra-uterine device (IUD), inserted at least one month prior to the Screening visit.
- If the Subject is female of childbearing potential, she has at Screening (at least 14 days before Baseline) and at Baseline a negative result for urine pregnancy test (UPT)having a sensitivity down to at least 25 Ul/ml for human chorionic gonadotrophin (hCG).
- If the Subject is a female of non-childbearing potential, she has to be postmenopausal (absence of menstrual bleeding for at least one year and without any other medical reason), or presenting with a hysterectomy or a bilateral ovariectomy.
Show all 9Show fewer
- The Subject is willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
- The Subject has understood and signed an Informed Consent Form (ICF) at Screening, prior to an investigational procedures being performed.
- The Subject is apprised of the Health Insurance Portability and Accountability Act (HIPAA), and is willing to share personal information and data, as verified by signing a written authorization at the screening.
Who cannot join
- The subject has any uncontrolled or serious disease (other than CTCL), or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
- The subject has known or suspected allergies or sensitivities to any components of the study drug (see Investigator's Brochure).
- The subject, if female, has a positive urinary pregnancy test, is breast-feeding or is planning a pregnancy during the course of the study.
- If the subject needs a relative to apply the study product, the relative is a female who is pregnant, lactating or intends to conceive during the clinical study or within 1 month after the last product application.
- The subject is in an exclusion period from a previous clinical study, takes part into any other clinical trial of a drug or device, OR participated within 1 month prior to baseline.
- The subject has used any of the following treatments or procedure before the first study treatment application (Baseline) within the wash-out periods defined below: corticoids or Aldera (imiquimod) 4 weeks; retinoids, nitrogen mustard (mechlorethamine), Carmustine (BCNU), or phototherapies 2 weeks, any systemic treatment dedicated to CTCL within 4 weeks.
Show all 10Show fewer
- The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
- The subject has an abnormal ECG judged clinically significant by the investigator and/or PR interval outside the range of 120 ms to 220 ms, QRS>120 ms, and corrected QT interval (QTc)>450 ms.
- The subject presents seropositivity for hepatitis B surface antigen(HBsAG), hepatitis C virus (HCV) antibody and /or human immunodeficiency virus (HIV) 1 and 2 antibody.
- The subject is vulnerable (such as deprived of freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Exploratory Study to Evaluate the Safety and Efficacy of CD5789 in Subjects With Early Stage Cutaneous T-Cell Lymphoma
The goal of this clinical research study is to learn if CD5789 is safe and tolerable when given to patients with early stage CTCL.
CD5789 is designed to attach to tumor cells and change their genetic material. This may stop the growth of the tumor cells.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will apply CD5789 cream 1 time each day. You should do this after you wash the area.
During your first study visit, the study staff will select which lesions you will apply cream to. The study staff will tell you how much cream to apply.
On Day 1, the study staff will apply the study drug on half of the lesions. You will apply the study drug to the rest of the lesions while the study staff watches. In a diary, the study staff will write down the time you applied the study drug. You must write down this information in the diary when you apply the study drug at home. On your Week 1 visit, you will apply the study drug at the clinic while the study staff watches.
You will use gloves to apply the study drug in a thin film on the lesions. Be careful not to overlap healthy skin. You should massage the study drug gently into the skin. If someone helps you apply the study drug, they must also wear gloves.
Bring the diary with you to each visit. You should return all unused study drug and/or empty tubes at each study visit.
You must avoid exposing the treated areas to the sun (you should wear clothing to cover these areas). You should also not swim or take a bath while on study, but you can take a shower at least 2 hours after you apply the drug.
If your skin is dry, you will be given a moisturizer (such as Cetaphil Restoraderm Skin Restoring Moisturizer) to use.
Study Visits:
At all study visits, you will asked about any drugs you may be taking or any side effects you may have had.
On Day 1:
- Any skin lesions will be measured and photographed. Your private areas will be covered as much as possible, and a picture of your face will not be taken.
- You will have a skin biopsy to check the status of the disease. To perform a skin biopsy, an area will be numbed with anesthetic and a small amount of skin will be removed with a small knife. The skin biopsy will be done before you apply the study drug.
- You will have tape stripping to measure any inflammatory markers on the skin. Inflammatory markers may be related to the status of the disease. To have tape stripping, small special pieces of tape will be applied to 1 skin lesion and to an area of normal skin next to it. When the tape loses it stickiness it will be collected by the study staff.
- You will have an EKG to check your heart function.
- You will be asked about how much you itch and if you have any burning or stinging sensations after applying the study drug.
- If you can become pregnant, urine will be collected for a urine pregnancy test.
At Weeks 1, 2, 4, and 8:
- Any skin lesions will be measured and photographed.
- You will be asked about how much you itch and if you have any burning or stinging sensations after applying the study drug.
At Weeks 4 and 8, if you can become pregnant, urine will be collected for a urine pregnancy test.
Length of Study:
You may continue using the study drug for up to 12 weeks, as long as the study doctor thinks it is in your best interest. You will no longer be able to use the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over when you have completed the end-of-study visit.
All samples collected during the study will be destroyed after the study has been completed and all patients are off study.
End-of-Study Visit:
On the last day you apply the study drug (Week 12), you will have an end-of-study visit:
- You will be asked about any other drugs and treatments you may be receiving.
- You will have a physical exam, including measurement of your vital signs.
- Any skin lesions will be examined and photographed.
- Blood (about 2½ teaspoons) will be drawn for routine tests. and to tests for HIV and/or hepatitis.
- Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing 12 hours after the study drug is applied at home PK testing measures the amount of study drug in the body at different time points.
- You will have an EKG to check your heart function.
- You will have a skin biopsy to check the status of the disease.
- You will have tape stripping to measure any inflammatory markers on the skin.
- If you can become pregnant, urine will be collected for a pregnancy test.
This is an investigational study. CD5789 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lymphoma
- Being tested
- CD5789 0.01% Cream
- Keywords
- Lymphoma, Early Stage Cutaneous T-Cell Lymphoma, CTCL, CD5789 0.01% cream
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5789 0.01% CreamDrug
CD5789 0.01% cream applied on the lesions once daily for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| CD5789 0.01% Cream | Experimental | CD5789 0.01% cream applied on the lesions once daily for twelve weeks. Receives: Drug: CD5789 0.01% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance Score of CD5789 0.01% Cream
Data analysis based on local tolerability score evaluated at each visit with a worst tolerance score for the subject calculated at each visit. Worst tolerance score is worst score of local tolerability of all index lesions for each subject at each visit. Worst tolerance score (max local tolerance score) summarized in frequency tables to follow the evolution of this score across visits for each subject.
Index lesion(s) evaluated at each visit for local tolerance (using a 5-point scale) from Week 1 visit to Week 12/ Early Termination visit for each index lesion. Tolerance 5-point scale from 0-No reaction to 4-Severe where the higher number the worse reaction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- Madeleine Duvic, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804335
- Sponsor's protocol ID
- 2012-0710
- Other IDs
- NCI-2014-01377
- Status last verified
- Apr 2016
- First submitted
- 1 Mar 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Safety and Efficacy of CD5789 in Subjects With Early Stage Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01804335
- Acronym / sponsor ID
- 2012-0710
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Early Stage Cutaneous T-Cell Lymphoma, CTCL, CD5789 0.01% cream
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if CD5789 is safe and tolerable when given to patients with early stage CTCL.
CD5789 is designed to attach to tumor cells and change their genetic material. This may stop the growth of the tumor cells.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will apply CD5789 cream 1 time each day. You should do this after you wash the area.
During your first study visit, the study staff will select which lesions you will apply cream to. The study staff will tell you how much cream to apply.
On Day 1, the study staff will apply the study drug on half of the lesions. You will apply the study drug to the rest of the lesions while the study staff watches. In a diary, the study staff will write down the time you applied the study drug. You must write down this information in the diary when you apply the study drug at home. On your Week 1 visit, you will apply the study drug at the clinic while the study staff watches.
You will use gloves to apply the study drug in a thin film on the lesions. Be careful not to overlap healthy skin. You should massage the study drug gently into the skin. If someone helps you apply the study drug, they must also wear gloves.
Bring the diary with you to each visit. You should return all unused study drug and/or empty tubes at each study visit.
You must avoid exposing the treated areas to the sun (you should wear clothing to cover these areas). You should also not swim or take a bath while on study, but you can take a shower at least 2 hours after you apply the drug.
If your skin is dry, you will be given a moisturizer (such as Cetaphil Restoraderm Skin Restoring Moisturizer) to use.
Study Visits:
At all study visits, you will asked about any drugs you may be taking or any side effects you may have had.
On Day 1:
- Any skin lesions will be measured and photographed. Your private areas will be covered as much as possible, and a picture of your face will not be taken.
- You will have a skin biopsy to check the status of the disease. To perform a skin biopsy, an area will be numbed with anesthetic and a small amount of skin will be removed with a small knife. The skin biopsy will be done before you apply the study drug.
- You will have tape stripping to measure any inflammatory markers on the skin. Inflammatory markers may be related to the status of the disease. To have tape stripping, small special pieces of tape will be applied to 1 skin lesion and to an area of normal skin next to it. When the tape loses it stickiness it will be collected by the study staff.
- You will have an EKG to check your heart function.
- You will be asked about how much you itch and if you have any burning or stinging sensations after applying the study drug.
- If you can become pregnant, urine will be collected for a urine pregnancy test.
At Weeks 1, 2, 4, and 8:
- Any skin lesions will be measured and photographed.
- You will be asked about how much you itch and if you have any burning or stinging sensations after applying the study drug.
At Weeks 4 and 8, if you can become pregnant, urine will be collected for a urine pregnancy test.
Length of Study:
You may continue using the study drug for up to 12 weeks, as long as the study doctor thinks it is in your best interest. You will no longer be able to use the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over when you have completed the end-of-study visit.
All samples collected during the study will be destroyed after the study has been completed and all patients are off study.
End-of-Study Visit:
On the last day you apply the study drug (Week 12), you will have an end-of-study visit:
- You will be asked about any other drugs and treatments you may be receiving.
- You will have a physical exam, including measurement of your vital signs.
- Any skin lesions will be examined and photographed.
- Blood (about 2½ teaspoons) will be drawn for routine tests. and to tests for HIV and/or hepatitis.
- Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing 12 hours after the study drug is applied at home PK testing measures the amount of study drug in the body at different time points.
- You will have an EKG to check your heart function.
- You will have a skin biopsy to check the status of the disease.
- You will have tape stripping to measure any inflammatory markers on the skin.
- If you can become pregnant, urine will be collected for a pregnancy test.
This is an investigational study. CD5789 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD5789 0.01% Cream | Experimental | Drug: CD5789 0.01% CreamCD5789 0.01% cream applied on the lesions once daily for twelve weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The Subject is a male or female, who is at least 18 years of age at Screening visit.
- The Subject has a clinical diagnosis of stable CTCL early stage (IA-IIA). The subject has :a) A known stable TNMB stage (cancer classification based on analysis of Tumors, Nodes, Metastasis and Blood), or b) Stable patch or plaque lesions that have not responded to topical treatment with corticosteroids or nitrogen mustard or which have relapsed after prior therapy.
- The Subject presents at least 3 distinct lesions (one selected as index lesion, one dedicated to biopsy and another one dedicated to tape-stripping).
- If the Subject is a female of childbearing potential, she agrees to use a highly contraceptive method for the duration of the study and for one month after the last product application. A highly effective method of contraception is defined by: 1) Bilateral tubal ligation 2) Combined oral contraceptives (estrogen and progesterone) implanted or injectable contraceptives, on a stable dose for at least 1 month prior to screening visit, 3) Hormonal intra-uterine device (IUD), inserted at least one month prior to the Screening visit.
- If the Subject is female of childbearing potential, she has at Screening (at least 14 days before Baseline) and at Baseline a negative result for urine pregnancy test (UPT)having a sensitivity down to at least 25 Ul/ml for human chorionic gonadotrophin (hCG).
Key exclusion criteria (10 listed)
- The subject has any uncontrolled or serious disease (other than CTCL), or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
- The subject has known or suspected allergies or sensitivities to any components of the study drug (see Investigator's Brochure).
- The subject, if female, has a positive urinary pregnancy test, is breast-feeding or is planning a pregnancy during the course of the study.
- If the subject needs a relative to apply the study product, the relative is a female who is pregnant, lactating or intends to conceive during the clinical study or within 1 month after the last product application.
- The subject is in an exclusion period from a previous clinical study, takes part into any other clinical trial of a drug or device, OR participated within 1 month prior to baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD5789 0.01% CreamCD5789 0.01% cream applied on the lesions once daily for twelve weeks. | Drug | CD5789 0.01% Cream |
Primary outcome
Tolerance Score of CD5789 0.01% Cream
Time frame: 12 weeks
Data analysis based on local tolerability score evaluated at each visit with a worst tolerance score for the subject calculated at each visit. Worst tolerance score is worst score of local tolerability of all index lesions for each subject at each visit. Worst tolerance score (max local tolerance score) summarized in frequency tables to follow the evolution of this score across visits for each subject. Index lesion(s) evaluated at each visit for local tolerance (using a 5-point scale) from Week 1 visit to Week 12/ Early Termination visit for each index lesion. Tolerance 5-point scale from 0-No reaction to 4-Severe where the higher number the worse reaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeleine Duvic, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD5789 0.01% Cream in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance Score of CD5789 0.01% Cream (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.