Graft vs Host DiseasePhase 2NCT01688466
Pomalidomide for Chronic Graft-versus-Host Disease
A Phase 2 study testing Pomalidomide in people with Graft vs Host Disease and Graft-Versus-Host Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Pomalidomide is a drug that alters the body's immune response. It may help people who have chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when immune cells in the transplant try to attack tissues in the person who received the transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Graft vs Host Disease, Graft-Versus-Host Disease
- What is being tested?
- Pomalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2012to 20 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe chronic graft-versus-host disease (cGvHD) diagnosed and staged per National Institutes of Health (NIH) criteria
- Greater than or equal to18-75 years of age, because no dosing or adverse event data are currently available on the use of pomalidomide in persons greater than or equal to18 years of age
- Has cGvHD that did not respond to high-dose corticosteroids (average 0.5 mg/kg/d prednisone for >8 weeks) or second-line systemic therapy
- If taking systemic therapy for cGvHD at the time of enrollment, must be on a stable or tapering schedule in the preceding 4 weeks (extracorporeal photopheresis has to be stopped at least by 4 weeks before enrollment)
- Karnofsky performance score greater than or equal to 60%
- Life expectancy >3 months
Show all 19Show fewer
- Stable primary malignancy for previous 3 months
- Agree to adhere to methods of contraception and other fertility control measures as prescribed by the protocol
- Because agents of this class are known to be teratogenic, women of childbearing potential and men must agree to use effective forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Females of childbearing potential (FCBP) (Cross) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10
- 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND Education and Counseling Guidance Document.
- Male Subjects
- Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation of study drug even if he has undergone a successful vasectomy
- Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure
- Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation of study drug.
- Must agree that if a pregnancy or a positive pregnancy test does occur in a study subject or the partner of a male study subject during study participation, study drug must be immediately discontinued.
- Patients must agree to not share study drug with anyone during participation in the study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- All study participants must be registered into the mandatory POMALYST REMS (TM) program, and be willing and able to comply with the requirements of the POMALYST REMS (TM) program.
Who cannot join
- Acute GvHD, classic (less than or equal to day 100) or late-onset (>day 100)
- Systemic immune suppression or systemic therapy for cGvHD started within preceding 4 weeks including extracorporeal photopheresis
- Hypersensitivity to thalidomide, lenalidomide or pomalidomide
- Any serious medical condition which places the subject at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Neutrophil <1.0x10(9)/L, platelets <75x10(9)/L, estimated creatinine clearance <50 mL/min/1.73m(2) (Cockroft-Gault formula) total bilirubin >3 mg/dL, transaminase>3xUNL
- Uncontrolled infection
Show all 12Show fewer
- Active human immunodeficiency virus 1 (HIV-1), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
- Uncontrolled arrhythmias or symptomatic heart disease or left ventricular ejection fraction (LVEF) <45%
- Other cancer except that for which the transplant was done <2 years before study entry, except non-melanoma skin cancer or carcinoma in situ of the uterine cervix or breast
- Taking other investigational drugs
- NIH lung score 3
- Pregnant women are excluded from this study because pomalidomide has potential for teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding must be discontinued while the mother is taking study drug and for at least 28 days after discontinuation of study drug. These potential risks may also apply to other agents used in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Randomized Phase 2 Single-Center Study of Pomalidomide for Chronic GvHD
Background:
- Pomalidomide is a drug that alters the body's immune response. It may help people who have chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when immune cells in the transplant try to attack tissues in the person who received the transplant. GvHD is not easy to treat, and often does not respond to standard treatments. Researchers want to see if pomalidomide is a safe and effective treatment for GvHD.
Read more
Objectives:
- To test the safety and effectiveness of pomalidomide for GvHD that has not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have GvHD that has not responded to standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. A lung function test and imaging studies will also be given.
- Participants will take pomalidomide capsules once a day for 4-week periods called cycles.
- Treatment will be monitored with frequent blood tests and imaging studies. Saliva samples and skin and mouth tissue biopsies will also be collected during treatment.
- Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side effects are too severe. If the GvHD has improved at the end of the six cycles, participants may be able to continue to take pomalidomide for up to six more cycles.
Read the detailed description
BACKGROUND:
- Chronic graft-versus-host disease (cGvHD) is the leading cause of non-relapse morbidity and mortality in persons after allogeneic hematopoietic cell transplants.
- About 50% of persons with cGvHD have disease refractory to systemic corticosteroids and there is no standard second-line therapy.
- Thalidomide, a drug with immune-modulating effects, was active in advanced cGvHD but was difficult to use at appropriate doses.
- Pomalidomide is related to thalidomide but with higher potency and more favorable toxicity profile. It is active in multiple myeloma and myeloproliferative neoplasm associated myelofibrosis. Preliminary data in humans with cGvHD are encouraging but data are limited.
OBJECTIVES:
- Primary: Determine whether pomalidomide is effective in persons with moderate or severe cGvHD not controlled by corticosteroids.
ELIGIBILITY:
Inclusion Criteria
- Moderate or severe cGvHD per National Institutes of Health (NIH) criteria
- Age 18 to 75 years old
- Karnofsky performance score greater than or equal to 60%
- Has cGvHD that did not respond to high-dose corticosteroids (average 0.5 mg/kg/d prednisone for greater than or equal to 8 weeks) or second-line therapy
- Receiving stable or tapering doses of systemic therapy in the preceding 4 weeks
- Agree to adhere to methods of contraception and other fertility control measures as prescribed by the protocol
Exclusion Criteria
- Acute GvHD (classic and late per NIH criteria)
- Absolute neutrophils <1.0x10(9)/L, platelets <75x10(9)/L, estimated creatinine clearance <50 mL/min/1.73m(2)
- NIH lung score 3
- Pregnant or lactating
- Uncontrolled infection
DESIGN:
Randomized phase 2 trial with the single stage selection design. Patients will receive either a constant low dose of pomalidomide (0.5 mg/day) for six months or a strategy of increasing dose of pomalidomide from 0.5 mg/d up through each individual patient's maximum tolerated dose, with escalations by 0.5 mg/d every 2 weeks to a maximum of 2.0 mg/d. As an early stopping rule for futility, if after 7 patients have enrolled on either arm, 0 have responded, then no further patients will be accrued to that arm as soon as this can be determined. To protect patient safety, an early stopping rule will be implemented. With two arms, each of which has a maximal accrual of 16 patients, up to 32 evaluable patients will be randomized. Response assessments will occur every 3 months with primary efficacy endpoint evaluated at 6 months. Patients with responding disease will continue therapy for another 6 months.
- Conditions
- Graft vs Host Disease, Graft-Versus-Host Disease
- Being tested
- Pomalidomide
- Keywords
- Immune Modulatory, Systemic Absorption, Oral Agent
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called POMALYST
0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg/day with Dose Escalation | Experimental | 0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day Receives: Drug: Pomalidomide |
| 0.5 mg/day without Dose Escalation | Experimental | 0.5 mg/day without Dose Escalation Receives: Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response at 6 Months
Overall response was assessed by the National Institutes of Health (NIH) Chronic Graft-Versus Host Disease (cGVHD) Response criteria. Complete response (CR) is complete resolution in all signs and symptoms at all affected organs or tissues. Partial response (PR) is improvement in ≥ 1 organ or tissue with no progression in any other affected organ or tissue. Response < PR is a change towards improvement from the pre-treatment baseline but not meeting the criteria for CR or PR. Stable disease (SD) is no change in cGVHD. Flare is exacerbation of cGVHD manifestations during withdrawal of immunosuppressive therapy which do not exceed those at the beginning of the trial and improves after reinstatement of previous treatment. Progressive disease (PD) is failure of therapy to control cGVHD . Mixed response (improvement in some organs but worsening in others) will be categorized as progressive disease.
Measured: 6 months
Secondary outcomes (1)
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0
Here is the count of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: 50 months and 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study start30 Aug 2012
- Primary completion30 Mar 2017
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Najla El Jurdi, National Cancer Institute (NCI)
- Investigators
- Najla El Jurdi, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688466
- Sponsor's protocol ID
- 120197
- Other IDs
- 12-C-0197
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2012
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolanos-Meade J, Vogelsang GB. Chronic graft-versus-host disease. Curr Pharm Des. 2008;14(20):1974-86. doi: 10.2174/138161208785061373.
PubMed 18691108Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33. doi: 10.1053/bbmt.2003.50026.
PubMed 12720215Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD, Foley R, Socie G, Carter S, Couriel D, Schultz KR, Flowers ME, Filipovich AH, Saliba R, Vogelsang GB, Pavletic SZ, Lee SJ; Design of Clinical Trials Working Group. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant. 2006 May;12(5):491-505. doi: 10.1016/j.bbmt.2006.03.004.
PubMed 16635784
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Single-Center Study of Pomalidomide for Chronic GvHD
- ClinicalTrials.gov ID
- NCT01688466
- Acronym / sponsor ID
- 120197
- Conditions
- Graft vs Host Disease, Graft-Versus-Host Disease
- Keywords
- Immune Modulatory, Systemic Absorption, Oral Agent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Aug 2012 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Pomalidomide is a drug that alters the body's immune response. It may help people who have chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when immune cells in the transplant try to attack tissues in the person who received the transplant. GvHD is not easy to treat, and often does not respond to standard treatments. Researchers want to see if pomalidomide is a safe and effective treatment for GvHD.
Objectives:
- To test the safety and effectiveness of pomalidomide for GvHD that has not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have GvHD that has not responded to standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. A lung function test and imaging studies will also be given.
- Participants will take pomalidomide capsules once a day for 4-week periods called cycles.
- Treatment will be monitored with frequent blood tests and imaging studies. Saliva samples and skin and mouth tissue biopsies will also be collected during treatment.
- Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side effects are too severe. If the GvHD has improved at the end of the six cycles, participants may be able to continue to take pomalidomide for up to six more cycles.
Detailed description
BACKGROUND:
- Chronic graft-versus-host disease (cGvHD) is the leading cause of non-relapse morbidity and mortality in persons after allogeneic hematopoietic cell transplants.
- About 50% of persons with cGvHD have disease refractory to systemic corticosteroids and there is no standard second-line therapy.
- Thalidomide, a drug with immune-modulating effects, was active in advanced cGvHD but was difficult to use at appropriate doses.
- Pomalidomide is related to thalidomide but with higher potency and more favorable toxicity profile. It is active in multiple myeloma and myeloproliferative neoplasm associated myelofibrosis. Preliminary data in humans with cGvHD are encouraging but data are limited.
OBJECTIVES:
- Primary: Determine whether pomalidomide is effective in persons with moderate or severe cGvHD not controlled by corticosteroids.
ELIGIBILITY:
Inclusion Criteria
- Moderate or severe cGvHD per National Institutes of Health (NIH) criteria
- Age 18 to 75 years old
- Karnofsky performance score greater than or equal to 60%
- Has cGvHD that did not respond to high-dose corticosteroids (average 0.5 mg/kg/d prednisone for greater than or equal to 8 weeks) or second-line therapy
- Receiving stable or tapering doses of systemic therapy in the preceding 4 weeks
- Agree to adhere to methods of contraception and other fertility control measures as prescribed by the protocol
Exclusion Criteria
- Acute GvHD (classic and late per NIH criteria)
- Absolute neutrophils <1.0x10(9)/L, platelets <75x10(9)/L, estimated creatinine clearance <50 mL/min/1.73m(2)
- NIH lung score 3
- Pregnant or lactating
- Uncontrolled infection
DESIGN:
Randomized phase 2 trial with the single stage selection design. Patients will receive either a constant low dose of pomalidomide (0.5 mg/day) for six months or a strategy of increasing dose of pomalidomide from 0.5 mg/d up through each individual patient's maximum tolerated dose, with escalations by 0.5 mg/d every 2 weeks to a maximum of 2.0 mg/d. As an early stopping rule for futility, if after 7 patients have enrolled on either arm, 0 have responded, then no further patients will be accrued to that arm as soon as this can be determined. To protect patient safety, an early stopping rule will be implemented. With two arms, each of which has a maximal accrual of 16 patients, up to 32 evaluable patients will be randomized. Response assessments will occur every 3 months with primary efficacy endpoint evaluated at 6 months. Patients with responding disease will continue therapy for another 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg/day with Dose Escalation | Experimental | Drug: Pomalidomide0.5 mg/day with Dose Escalation by 0.5 mg/day increments every 2 weeks to a maximum of 2.0 mg/day |
| 0.5 mg/day without Dose Escalation | Experimental | Drug: Pomalidomide0.5 mg/day without Dose Escalation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Moderate or severe chronic graft-versus-host disease (cGvHD) diagnosed and staged per National Institutes of Health (NIH) criteria
- Greater than or equal to18-75 years of age, because no dosing or adverse event data are currently available on the use of pomalidomide in persons greater than or equal to18 years of age
- Has cGvHD that did not respond to high-dose corticosteroids (average 0.5 mg/kg/d prednisone for >8 weeks) or second-line systemic therapy
- If taking systemic therapy for cGvHD at the time of enrollment, must be on a stable or tapering schedule in the preceding 4 weeks (extracorporeal photopheresis has to be stopped at least by 4 weeks before enrollment)
- Karnofsky performance score greater than or equal to 60%
Key exclusion criteria (12 listed)
- Acute GvHD, classic (less than or equal to day 100) or late-onset (>day 100)
- Systemic immune suppression or systemic therapy for cGvHD started within preceding 4 weeks including extracorporeal photopheresis
- Hypersensitivity to thalidomide, lenalidomide or pomalidomide
- Any serious medical condition which places the subject at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Neutrophil <1.0x10(9)/L, platelets <75x10(9)/L, estimated creatinine clearance <50 mL/min/1.73m(2) (Cockroft-Gault formula) total bilirubin >3 mg/dL, transaminase>3xUNL
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 |
|---|---|---|
| PomalidomideAlso: POMALYST0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle | Drug | 0.5 mg/day with Dose Escalation, 0.5 mg/day without Dose Escalation |
Primary outcome
Overall Response at 6 Months
Time frame: 6 months
Overall response was assessed by the National Institutes of Health (NIH) Chronic Graft-Versus Host Disease (cGVHD) Response criteria. Complete response (CR) is complete resolution in all signs and symptoms at all affected organs or tissues. Partial response (PR) is improvement in ≥ 1 organ or tissue with no progression in any other affected organ or tissue. Response < PR is a change towards improvement from the pre-treatment baseline but not meeting the criteria for CR or PR. Stable disease (SD) is no change in cGVHD. Flare is exacerbation of cGVHD manifestations during withdrawal of immunosuppressive therapy which do not exceed those at the beginning of the trial and improves after reinstatement of previous treatment. Progressive disease (PD) is failure of therapy to control cGVHD . Mixed response (improvement in some organs but worsening in others) will be categorized as progressive disease.
1 secondary outcome
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0
Time frame: 50 months and 20 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18691108Bolanos-Meade J, Vogelsang GB. Chronic graft-versus-host disease. Curr Pharm Des. 2008;14(20):1974-86. doi: 10.2174/138161208785061373.
- Background: PubMed 12720215Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33. doi: 10.1053/bbmt.2003.50026.
- Background: PubMed 16635784Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD, Foley R, Socie G, Carter S, Couriel D, Schultz KR, Flowers ME, Filipovich AH, Saliba R, Vogelsang GB, Pavletic SZ, Lee SJ; Design of Clinical Trials Working Group. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant. 2006 May;12(5):491-505. doi: 10.1016/j.bbmt.2006.03.004.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Najla El Jurdi, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pomalidomide in people with Graft vs Host Disease and Graft-Versus-Host Disease, run by National Cancer Institute (NCI) 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 19 inclusion and 12 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 8 Oct 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688466, which also lists 3 linked publications.
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 8 Oct 2025.