Hodgkin DiseasePhase 2TXCH-HD-12ANCT01858922
Chemotherapy With or Without Radiation, Low and Intermediate Risk Hodgkins Lymphoma, TXCH-HD-12A
A Phase 2 study testing ABVE-PC and DECA in people with Hodgkin Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. HD is one of the most treatable childhood cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- ABVE-PC and DECA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2012to 12 Aug 2019
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with newly diagnosed, histologically confirmed Hodgkin Lymphoma (HD) who meet the following criteria:
- Stage IA and IB (non-bulky nodular lymphocyte predominant)
- Stage IIA and IIB
- Stage IIIA
- Stage IVA
Who cannot join
- Patients with Stage IA-IIA non-bulky lymphocyte predominant histology
- Patients who have received previous chemotherapy or radiation therapy (does NOT include steroids).
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <27%).
- Patients with severe renal disease (i.e. Measured or estimated creatinine clearance or radioisotope GFR <= 70 ml/min/1.73 m2).
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 60% of predicted).
- Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L).
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- Known HIV positivity
- Patients with a Karnofsky performance score <70% or Lansky score <70%.
- Female patients who are pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A
Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. HD is one of the most treatable childhood cancers. The standard treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured from their cancer, some patients experience negative side effects from treatment later in life. These kinds of side effects are often referred to as late effects. This can include problems with growth, problems with some organ functions, and sometimes second cancers. These types of effects can be associated with either chemotherapy or radiation therapy. The investigators are therefore designing studies to minimize or prevent these late effects. It is thought that if some patients can be successfully treated without radiation, those patients might experience fewer late side effects.
Some patients, however, do not respond as well to the first stages of treatment (slow early responders). Slow early responders are considered to be at higher risk for relapse. This study also looks at whether these kinds of patients will benefit from additional chemotherapy.
The purpose of this study is to look at how the immune system recovers and at how certain T-cells in the blood behave after receiving chemotherapy with or without radiation. The investigators also want to identify if bio-markers (special proteins in blood and in cancer) relate to the response of HD to study treatment.
Read the detailed description
At first the subject will have 2 cycles of cancer drugs (Doxorubicin, Bleomycin, Vincristine, Etoposide, Prednisone, Cyclophosphamide). The doctors call this combination of cancer drugs ABVE-PC for short. A cycle equals 21 days. The cancer drugs will be given intravenously (IV).
Those patients evaluated as having an early response to treatment will be put in the group of Rapid Early Responders (RERs). The RER group includes those patients whose disease has been reduced by 60% or more. The next step for patients with RERs is 2 more cycles of ABVE-PC chemotherapy followed by another evaluation of their response. Those determined to have a complete response (at least an 80% disease reduction) will receive no further therapy. Those patients determined to have less than a complete response will receive radiation therapy within 6 weeks after the last cycle or when blood counts are recovered. Radiation therapy will be given to the involved areas and by the standard of care of this hospital (Texas Children's Hospital). After radiation the subject will be off treatment.
Patients with disease reduction less than 60% are put in the group of Slow Early Responders (SERs). The next step for patients with SER is 2 cycles of DECA (Dexamethasone, Etoposide, Cytarabine, and Cisplatin). On Days 1 and 2, the subject will be given dexamethasone IV first; afterwards, then they will receive the Etoposide and Cytarabine mixture. Cisplatin will be given by IV only on Day 1.
BIOLOGY TESTS The doctors are investigating molecules in tumors and blood that may help them better understand the biology of Hodgkin's Disease. These studies may also help them understand differences in patients' responses to therapy.
TISSUE FOR BIOMARKER STUDIES The doctors want to study the material that shows the make-up of the cancer (the genes of the cancer tissue) and the special "markers" of the tissue. Tissue from the subject's cancer biopsies will be used for these studies. They will collect these samples when the subject has a biopsy for clinical reasons.
IMMUNE FUNCTION AND BIOMARKER BLOOD TESTS The doctors also want to collect blood samples to study the subject's immune system and to look at biomarkers in the blood.
- Conditions
- Hodgkin Disease
- Being tested
- ABVE-PC, DECA
- Keywords
- Hodgkin's Lymphoma, ABVE-PC, doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide, DECA, decadron, cisplatin, cytarabine, Radiation
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABVE-PCDrug
Also called Doxorubicin (A), Bleomycin (B), Vincristine (V), Etoposide (E)
Doxorubicin (A) 25mg/m2/day IV over 10min on Day 1 \& Day 2
Bleomycin (B) 5units/m2/day IV over 10min on Day 1 10units/m2/day IV over 10min on Day 8
Vincristine (V) 1.4mg/m2/day IV push with extravasation precautions on Day 1 \& 8 (Max dose 2.8mg)
Etoposide (E) 125mg/m2/day IV over 1hr at a concentration of </=0.4mg/ml in NS on Day 1, 2 \& 3
Prednisone (P) 40mg/m2/day PO divided in 2 doses every day on Day 1-7 IV equivalent of methylprednisolone is acceptable
Cyclophosphamide (C) 800 mg/m2 IV over 1 hr in 200 ml/m2 NS on Day 1
DECADrug
Also called Dexamethasone (D), Etoposide (E), Cytarabine (A), Cisplatin (C)
Dexamethasone (D):
10 mg/m2 IV over 15 minutes on Day 1 and Day 2, prior to Etoposide/Cytarabine.
Etoposide (E):
100 mg/m2 IV over 3 hours on Day 1 and Day 2 as continuous infusion mixed with cytarabine*
Cytarabine (A):
3000 mg/m2 IV over 3 hours on Day 1 and Day 2 as continuous infusion mixed with etoposide*
*Mix together in NS at an etoposide concentration of </=0.4 mg/ml
Dexamethasone eyedrops:
2 drops in each eye 4 times a day on Day 1, Day 2, and Day 3.
Cisplatin (C):
90 mg/m2 over 6 hours in 1000 ml/m2 NS + 10 gram/m2 mannitol on Day 1 as continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Early Responders | Experimental | All patients will have initial treatment utilizing ABVE-PC x2 cycles. Those patients with rapid early response (RER) determined by FDG-PET/CT scan after two cycles of ABVE-PC will receive two more cycles of ABVE-PC. If subsequent PET/CT scan indicates a complete response (CR), therapy will stop and regular follow-up will begin. If the subsequent PET/CT for RER patients indicates a partial response, those patients will undergo IFRT. Receives: Drug: ABVE-PC |
| Slow Early Responders | Experimental | All patients will have initial treatment utilizing ABVE-PC x2 cycles. Those patients determined to have a slow early response (SER) determined by PET/CT scan after two cycles of ABVE-PC will receive 2 courses of DECA. If after PET/CT, the patient has a partial or complete response, then 2 additional courses of ABVE-PC will be given. If subsequent PET/CT scan indicates PR or CR, those patients will then undergo IFRT.
If stable or progressive disease is found at either PET/CT scan, the patient will be taken off-study and follow up will begin. Receives: Drug: ABVE-PC; Drug: DECA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to therapy from Day 1 of Treatment
To define the general immune recovery in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy. Descriptive analysis of response to therapy, event-free survival, overall survival, relapse, and infection will be summarized using summary statistics.
Measured: up to 18 months
Changes in Frequency of Regulatory Cell Population
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD who receive chemotherapy with or without radiation therapy using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Measured: Baseline and 3 Months
Changes in Frequency of Regulatory Cell Population
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy will be analyzed using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Measured: Baseline to 6 months
Changes in Frequency of Regulatory Cell Population
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy will be analyzed using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Measured: Baseline to 12 Months
Changes in Frequency of Regulatory Cell Population
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy will be analyzed using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Measured: Baseline to 18 Months
Function of Regulatory Cell Population
To identify tumor and circulating biomarkers in patients with low and intermediate risk HD who receive chemotherapy with or without radiation therapy and correlate with clinical outcomes including incidence of relapse and infection using random coefficient mixed models and multivariate cox proportional hazard modeling.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start19 Dec 2012
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Allen, Baylor College of Medicine
- Investigators
- Carl E. Allen, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858922
- Sponsor's protocol ID
- H-30993 TXCH-HD-12A
- Other IDs
- TXCH-HD-12A
- Acronym
- TXCH-HD-12A
- Status last verified
- Jan 2024
- First submitted
- 17 May 2013
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A
- ClinicalTrials.gov ID
- NCT01858922
- Acronym / sponsor ID
- TXCH-HD-12A / H-30993 TXCH-HD-12A
- Conditions
- Hodgkin Disease
- Keywords
- Hodgkin's Lymphoma, ABVE-PC, doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 19 Dec 2012 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 21 May 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.
Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. HD is one of the most treatable childhood cancers. The standard treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured from their cancer, some patients experience negative side effects from treatment later in life. These kinds of side effects are often referred to as late effects. This can include problems with growth, problems with some organ functions, and sometimes second cancers. These types of effects can be associated with either chemotherapy or radiation therapy. The investigators are therefore designing studies to minimize or prevent these late effects. It is thought that if some patients can be successfully treated without radiation, those patients might experience fewer late side effects.
Some patients, however, do not respond as well to the first stages of treatment (slow early responders). Slow early responders are considered to be at higher risk for relapse. This study also looks at whether these kinds of patients will benefit from additional chemotherapy.
The purpose of this study is to look at how the immune system recovers and at how certain T-cells in the blood behave after receiving chemotherapy with or without radiation. The investigators also want to identify if bio-markers (special proteins in blood and in cancer) relate to the response of HD to study treatment.
Detailed description
At first the subject will have 2 cycles of cancer drugs (Doxorubicin, Bleomycin, Vincristine, Etoposide, Prednisone, Cyclophosphamide). The doctors call this combination of cancer drugs ABVE-PC for short. A cycle equals 21 days. The cancer drugs will be given intravenously (IV).
Those patients evaluated as having an early response to treatment will be put in the group of Rapid Early Responders (RERs). The RER group includes those patients whose disease has been reduced by 60% or more. The next step for patients with RERs is 2 more cycles of ABVE-PC chemotherapy followed by another evaluation of their response. Those determined to have a complete response (at least an 80% disease reduction) will receive no further therapy. Those patients determined to have less than a complete response will receive radiation therapy within 6 weeks after the last cycle or when blood counts are recovered. Radiation therapy will be given to the involved areas and by the standard of care of this hospital (Texas Children's Hospital). After radiation the subject will be off treatment.
Patients with disease reduction less than 60% are put in the group of Slow Early Responders (SERs). The next step for patients with SER is 2 cycles of DECA (Dexamethasone, Etoposide, Cytarabine, and Cisplatin). On Days 1 and 2, the subject will be given dexamethasone IV first; afterwards, then they will receive the Etoposide and Cytarabine mixture. Cisplatin will be given by IV only on Day 1.
BIOLOGY TESTS The doctors are investigating molecules in tumors and blood that may help them better understand the biology of Hodgkin's Disease. These studies may also help them understand differences in patients' responses to therapy.
TISSUE FOR BIOMARKER STUDIES The doctors want to study the material that shows the make-up of the cancer (the genes of the cancer tissue) and the special "markers" of the tissue. Tissue from the subject's cancer biopsies will be used for these studies. They will collect these samples when the subject has a biopsy for clinical reasons.
IMMUNE FUNCTION AND BIOMARKER BLOOD TESTS The doctors also want to collect blood samples to study the subject's immune system and to look at biomarkers in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Early Responders | Experimental | Drug: ABVE-PCAll patients will have initial treatment utilizing ABVE-PC x2 cycles. Those patients with rapid early response (RER) determined by FDG-PET/CT scan after two cycles of ABVE-PC will receive two more cycles of ABVE-PC. If subsequent PET/CT scan indicates a complete response (CR), therapy will stop and regular follow-up will begin. If the subsequent PET/CT for RER patients indicates a partial response, those patients will undergo IFRT. |
| Slow Early Responders | Experimental | Drug: ABVE-PC, Drug: DECAAll patients will have initial treatment utilizing ABVE-PC x2 cycles. Those patients determined to have a slow early response (SER) determined by PET/CT scan after two cycles of ABVE-PC will receive 2 courses of DECA. If after PET/CT, the patient has a partial or complete response, then 2 additional courses of ABVE-PC will be given. If subsequent PET/CT scan indicates PR or CR, those patients will then undergo IFRT. If stable or progressive disease is found at either PET/CT scan, the patient will be taken off-study and follow up will begin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with newly diagnosed, histologically confirmed Hodgkin Lymphoma (HD) who meet the following criteria:
- Stage IA and IB (non-bulky nodular lymphocyte predominant)
- Stage IIA and IIB
- Stage IIIA
- Stage IVA
Key exclusion criteria (9 listed)
- Patients with Stage IA-IIA non-bulky lymphocyte predominant histology
- Patients who have received previous chemotherapy or radiation therapy (does NOT include steroids).
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <27%).
- Patients with severe renal disease (i.e. Measured or estimated creatinine clearance or radioisotope GFR <= 70 ml/min/1.73 m2).
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 60% of predicted).
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 |
|---|---|---|
| ABVE-PCAlso: Doxorubicin (A), Bleomycin (B), Vincristine (V), Etoposide (E)Doxorubicin (A) 25mg/m2/day IV over 10min on Day 1 \& Day 2 Bleomycin (B) 5units/m2/day IV over 10min on Day 1 10units/m2/day IV over 10min on Day 8 Vincristine (V) 1.4mg/m2/day IV push with extravasation precautions on Day 1 \& 8 (Max dose 2.8mg) Etoposide (E) 125mg/m2/day IV over 1hr at a concentration of </=0.4mg/ml in NS on Day 1, 2 \& 3 Prednisone (P) 40mg/m2/day PO divided in 2 doses every day on Day 1-7 IV equivalent of methylprednisolone is acceptable Cyclophosphamide (C) 800 mg/m2 IV over 1 hr in 200 ml/m2 NS on Day 1 | Drug | Rapid Early Responders, Slow Early Responders |
| DECAAlso: Dexamethasone (D), Etoposide (E), Cytarabine (A), Cisplatin (C)Dexamethasone (D): 10 mg/m2 IV over 15 minutes on Day 1 and Day 2, prior to Etoposide/Cytarabine. Etoposide (E): 100 mg/m2 IV over 3 hours on Day 1 and Day 2 as continuous infusion mixed with cytarabine* Cytarabine (A): 3000 mg/m2 IV over 3 hours on Day 1 and Day 2 as continuous infusion mixed with etoposide* *Mix together in NS at an etoposide concentration of </=0.4 mg/ml Dexamethasone eyedrops: 2 drops in each eye 4 times a day on Day 1, Day 2, and Day 3. Cisplatin (C): 90 mg/m2 over 6 hours in 1000 ml/m2 NS + 10 gram/m2 mannitol on Day 1 as continuous infusion. | Drug | Slow Early Responders |
Primary outcome
Response to therapy from Day 1 of Treatment
Time frame: up to 18 months
To define the general immune recovery in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy. Descriptive analysis of response to therapy, event-free survival, overall survival, relapse, and infection will be summarized using summary statistics.
Changes in Frequency of Regulatory Cell Population
Time frame: Baseline and 3 Months
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD who receive chemotherapy with or without radiation therapy using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Changes in Frequency of Regulatory Cell Population
Time frame: Baseline to 6 months
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy will be analyzed using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Changes in Frequency of Regulatory Cell Population
Time frame: Baseline to 12 Months
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy will be analyzed using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Changes in Frequency of Regulatory Cell Population
Time frame: Baseline to 18 Months
To identify the behavior of antigen-specific cytotoxic T-cells and specific chemokine/cytokine biomarkers in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy will be analyzed using means, medians, standard deviations, and confidence interval estimates. Pairwise comparisons, paired t-tests, and/or Wilcoxon signed-rank tests will be used to compare the changes.
Function of Regulatory Cell Population
Time frame: Up to 18 months
To identify tumor and circulating biomarkers in patients with low and intermediate risk HD who receive chemotherapy with or without radiation therapy and correlate with clinical outcomes including incidence of relapse and infection using random coefficient mixed models and multivariate cox proportional hazard modeling.
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 12 Jan 2024.
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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.
Carl E. Allen, MD, PhD principal investigator
Baylor College of Medicine
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 ABVE-PC and DECA in people with Hodgkin Disease, run by Baylor College of Medicine 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 5 inclusion and 9 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 12 Jan 2024. 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?
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?
Response to therapy from Day 1 of Treatment (time frame: up to 18 months). The study lists 6 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 12 Jan 2024.