Cutaneous T Cell LymphomaEarly Phase 1NCT03235869
Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
A Early Phase 1 study testing Durvalumab and Radiation Therapy in people with Cutaneous T Cell Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma
- What is being tested?
- Durvalumab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Mar 2023
- Phase
- Early 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
- Voluntarily provide written IRB-approved consent
- Age ≥ 18 years
- Histologically proven CTCL
- Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response
- At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.
- Adequate organ function
- Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity
Who cannot join
- Prior allogeneic stem cell transplant.
- Prior treatment with a PD-1/PD-L1 inhibitor
- Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
- Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.
- Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
- History of hypersensitivity to durvalumab or any excipient
Show all 10Show fewer
- Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
- Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control
- Male subjects who are not employing an effective method of birth control
- Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
- Conditions
- Cutaneous T Cell Lymphoma
- Being tested
- Durvalumab, Radiation Therapy
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
Radiation TherapyRadiation
Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy + Durvalumab | Experimental | Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days. Receives: Drug: Durvalumab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients that respond to treatment
Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Measured: 1 year post treatment
The percentage of patients that completely respond to treatment
Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Measured: 1 year post treatment
Secondary outcomes (4)
Time to response
The time to response is measured from the start of the treatment until criteria are met for CR or PR. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Measured: 1 year post treatment
Duration of overall response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD (Progressive disease) is objectively documented. A global composite scoring system will be used to determine response and progression. Skin, nodes, viscera and blood will be assessed.
Measured: 1 year post treatment
Progression free survival time
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. A global composite scoring system will be used to determine progression. Skin, nodes, viscera and blood will be assessed.
Measured: 1 year post treatment
Time to next treatment
Time to next treatment is defined as the duration of time from start of study treatment to next treatment or death of any cause, whichever comes first.
Measured: 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: The company pulled durvalumab from heme malignancies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- "Ryan Wilcox, M.D., Ph.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235869
- Sponsor's protocol ID
- UMCC 2017.079
- Other IDs
- HUM00131550
- Status last verified
- Mar 2018
- First submitted
- 27 Jul 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03235869
- Acronym / sponsor ID
- UMCC 2017.079
- Conditions
- Cutaneous T Cell Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company pulled durvalumab from heme malignancies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 1 Aug 2017 (actual)
- 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.
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy + Durvalumab | Experimental | Drug: Durvalumab, Radiation: Radiation TherapyRadiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily provide written IRB-approved consent
- Age ≥ 18 years
- Histologically proven CTCL
- Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response
- At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.
Key exclusion criteria (10 listed)
- Prior allogeneic stem cell transplant.
- Prior treatment with a PD-1/PD-L1 inhibitor
- Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
- Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.
- Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
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 |
|---|---|---|
| DurvalumabDurvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days. | Drug | Radiation Therapy + Durvalumab |
| Radiation TherapyRadiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) | Radiation | Radiation Therapy + Durvalumab |
Primary outcome
The percentage of patients that respond to treatment
Time frame: 1 year post treatment
Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
The percentage of patients that completely respond to treatment
Time frame: 1 year post treatment
Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
4 secondary outcomes
Time to response
Time frame: 1 year post treatment
Duration of overall response
Time frame: 1 year post treatment
Progression free survival time
Time frame: 1 year post treatment
Time to next treatment
Time frame: 1 year post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
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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.
"Ryan Wilcox, M.D., Ph.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Durvalumab and Radiation Therapy in people with Cutaneous T Cell Lymphoma, run by University of Michigan Rogel 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 7 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: withdrawn, as of the sponsor's last update on 15 Mar 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
The percentage of patients that respond to treatment (time frame: 1 year post treatment). The study lists 2 primary outcomes in all. 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 15 Mar 2018.