Myelodysplastic SyndromesPhase 2TMLI-RINCT06602323
TMLI/Fludarabine/Melphalan Conditioning for Allogeneic Transplantation in High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia.
A Phase 2 study testing TMLI/Flu/Mel in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Trial summary
The goal of this clinical trial is to learn if drugs (fludarabine and melphalan) combinated with a targeted irradiation (in bone marrow and in lymphoid tissue) works to treat blood cancers (high risk myelodysplastic syndrome or acute myeloid leukemia) in adults. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- What is being tested?
- TMLI/Flu/Mel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has the ability and willingness to sign the informed consent document. (For adults, only participants with mild cognitive abilities may use a legally authorized representative).
- Documented (signed) informed consent. The patient, family member, and doctor of the transplant staff (doctor, nurse, and social worker) meet at least once before the transplant procedure begins. During this meeting, all relevant information regarding the risks and benefits to the donor and recipient will be presented. Alternative treatment modalities will be discussed. The risks are explained in detail in the attached consent forms.
- Age: ≥ 50 years or Haematopoietic Cell Transplantation-Comorbidity Index pre-transplant score ≥ 3 or any other condition that precludes the use of a fully myeloablative conditioning regimen.
- Karnofsky's performance status ≥ 70%.
- Patients with myelodysplastic syndrome/acute myeloid leukemia or acute myeloid leukemia with relapsed/refractory active disease (i.e. ≥5% bone marrow blasts), or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing (in the case of fms-like tyrosine kinase-3 internal tandem duplication-mutated AML).
- All candidates for this study must have an 8/8 human leukocyte antigens-identical (A, B, C, DR) sibling donor or an unrelated donor with at least 8/8 human leukocyte antigens matching. A single allele mismatch in A, B, C, DR or dq and a kir mismatch in C shall be allowed. All combinations of donor/recipient "abo" blood types are acceptable; as even major "abo" compatibilities can be treated using a variety of techniques (red blood cell exchange or plasma exchange).
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- The time elapsed since the end of the last induction or re-induction cycle must be greater than or equal to 14 days.
- Total bilirubin ≤ 1.5 mg/dL x Upper Limit of Normality OR 3 x upper limit of normal for Gilbert's disease.
- Serum glutamate oxaloacetate transaminase \& serum glutamate pyruvate transaminase ≤ 5 x Upper Limit of Normality.
- Serum creatinine ≤ 1.3 mg/dL or creatinine clearance measured ≥ 80 mL/min for 24 hours of urine collection.
- Women of childbearing age only: Negative urine or serum pregnancy test.
- Men AND women of childbearing potential agree to use appropriate contraceptives (hormonal or barrier contraception or abstinence) prior to study entry and for six months following the duration of study participation. If a woman becomes pregnant or suspects she is pregnant while participating in the trial, she should inform her treating physician immediately.
- Pulmonary function tests: forced expiratory volume in one second (FEV1) and Carbon Monoxide Diffusion Capacity (DLCO) (adjusted for Hb) ≥ 50% from expected normal value.
- Patients should undergo cardiac evaluation with an electrocardiogram showing no ischemic changes or clinically relevant arrhythmia, and a ≥50% ejection fraction established by multigated acquisition scan or echocardiogram.
- ECG showing no ischemic changes or clinically significant arrhythmia.
- The time elapsed since the end of the last induction or reinduction cycle must be greater than or equal to 14 days.
Who cannot join
- Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded.
- Previous radiation therapy which would preclude the use of TMLI.
- Plans during the trial to receive any other investigational (non-trial-related) agents.
- Uncontrolled disease, including ongoing or active infection.
- History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide.
- Patients with other active malignancies are not eligible for this study, other than the malignancies discussed.
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- Patients with a psychological or medical condition that the patient's physician deems unacceptable to proceed with allogeneic hematopoietic stem cell transplantation.
- Women who plan to become pregnant or breastfeed during the trial.
- Patients who do not agree to practice effective forms of contraception.
- Subjects who, in the opinion of the investigator, may not be able to meet the safety control requirements of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Study of Total Marrow and Lymphoid Irradiation (TMLI) Administered in Combination With a Reduced-intensity Regimen Based on Fludarabine and Melphalan as Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT) in Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia.
The goal of this clinical trial is to learn if drugs (fludarabine and melphalan) combinated with a targeted irradiation (in bone marrow and in lymphoid tissue) works to treat blood cancers (high risk myelodysplastic syndrome or acute myeloid leukemia) in adults. It will also learn about the safety of this combination of drugs and irradiation. The main questions it aims to answer are:
- Does this combined therapy result in an improved survival and decreased relapse/progression rate after a bone marrow transplant?
- What toxicities or complications do participants have when taking this combined therapy?
Read more
Researchers will use this combined therapy to see if it works to treat high risk myelodysplastic syndrome or acute myeloid leukemia through the evaluation of the length of time (during the treatment and 2 years after the treatment) that a patient lives with the disease but it does not get worse (progression-free survival).
Participants will:
- Receive the combined therapy (study treatment) one week before the bone marrow transplant.
- Receive too post-transplant medication as per usual clinical practice.
Patients will have to attend medical visits (checkups and tests) for 2 years.
Read the detailed description
This is a single-arm, single center phase II trial to evaluate the antileukemic activity and safety of the AHSCT TMLI/Flu/Mel conditioning regimen in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia. A patient safety-lead phase will be carried out to ensure there are no unexpected toxicities. Ultimately, a total of 34 patients will be treated at the TMLI/Flu/Mel dose level deemed safe as determined during the introductory patient safety segment of this study.
Up to three dose levels can be studied. A 3+3 de-escalation design comprising a patient safety-lead phase will be applied in successive patient cohorts to evaluate the safety of the TMLI schedule and identify the optimal treatment dose:
Initially, 3 patients will be treated at the starting TMLI dose (Dose Level 1, 1200 cGy). If 0 or 1 DLT is observed among the first 6 patients at Dose Level 1, then 28 additional patients will be treated at this dose level (allowing for the evaluation of 34 patients treated at the target dose level). If ≥2/6 patients experience a DLT at Dose Level 1, then the MTD has been exceeded and the next lower TMLI dose (Dose Level -1, 1100 cGy) will be expanded to up to 6 patients. If 0 or 1 patient out of 6 experiences a DLT, this dose level will be further evaluated (n=28 additional patients). If ≥2/6 patients experience a DLT, the next lower dose (Dose Level -2, 1000 cGy) level will be expanded applying the same criteria. No further dose level reductions will be allowed beyond Dose Level -2.
No more than 3 patients may be \<30 days after stem cell infusion at any time during patient safety introduction. The tacrolimus dose and MMF dose will remain fixed for all defined dose levels and will not be reduced at any time.
Considering this proposed design, the expected sample size of the study will be n=34 patients, with a potential minimum and maximum size of n=34 and n=46, respectively.
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Being tested
- TMLI/Flu/Mel
- Keywords
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMLI/Flu/MelCombination product
Targeted total bone marrow and lymphoid irradiation (TMLI) conformal therapy administered in combination with a reduced-intensity regimen based on Fludarabine and Melphalan.
| Study group | Role | What they receive |
|---|---|---|
| TMLI/Flu/Mel conditioning regimen (Single-arm) | Other | Single-arm.
TMLI:
Dose level 1: 1200 cGy = 150 cGy x 8 doses (liver, brain, and hepatic portal limited to 720 cGy) Dose level -1: 1100 cGy = 137.5 cGy x 8 doses (liver, brain, and hepatic portal limited to 720 cGy) Dose level -2: 1000 cGy = 125 cGy x 8 doses (liver, brain, and hepatic portal limited to 720 cGy) Dose levels above 1,200 cGy will not be considered in this protocol, as the dose to off-target avoidance organs would exceed the recommended levels in reduced-intensity transplants.
TMLI will be administered by helical tomotherapy for 4 consecutive days (day -7 to day -4), delivering 2 fractions per day (a total of 8 doses) with a minimum of 6 hours between fractions.
FLURADABINE:
Dose: 25 mg/m2 Route of administration: intravenous. Treatment duration: for 4 consecutive days (day -7 to day -4 pre-transplant).
MELPHALAN:
Dose: 140 mg/m2 Route of administration: intravenous Treatment duration: for 1 day (day -2 pre-transplant). Receives: Combination Product: TMLI/Flu/Mel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from the start of treatment to the date of death, disease relapse/progression, or date of last follow-up.
Measured: From the start of therapy to 2 years after study treatment
Secondary outcomes (9)
Overall survival
Quantification of time of patients who are still alive.
Measured: From the start of therapy to 2 years after post-transplant.
Cumulative incidence of recurrence/progression
The event is relapse/progression either extramedullary or at bone marrow
Measured: From the start of therapy to 2 years after post-transplant.
Complete remission date
The event is whether or not the patient has a documented complete remission.
Measured: From the day of infusion to the day 30 post-transplant.
Non-relapse mortality
Number of deaths from causes other than relapse or progression.
Measured: From the start of therapy until 2 years after post-transplant.
Measurable residual disease
Measurable residual disease monitoring assessed by multiparameter flow cytometry.
Measured: At 30, 90, 180 days and 1 year, 1.5 years and 2 years post-transplant.
Incidence of infection
Microbiologically documented infections.
Measured: 2 years after post-transplant.
Adverse events
Any untoward medical occurrence in a patient participating in clinical research that is associated in time with the use of a medicinal product, whether or not it is considered to be related to the investigational products.
Measured: 2 years after post-transplant.
Acute graft-versus-host disease grades 2-4 and 3-4
This point is classified according to the NIH criteria.
Measured: 100 days post-transplant.
Chronic graft-versus-host disease
Chronic graft-versus-host disease is graded according to the NIH consensus staging.
Measured: 2 years after post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- A 3+3 de-escalation design comprising a patient safety-lead phase will be applied in successive patient cohorts: Initially, 3 patients will be treated at the starting TMLI dose (Dose Level 1, 1200 cGy). If 0 or 1 dose-limiting toxicity is observed among the first 6 patients at Dose Level 1, then 28 additional patients will be treated at this dose level (allowing for the evaluation of 34 patients treated at the target dose level). If ≥2/6 patients experience a dose-limiting toxicity at Dose Level 1, then the maximum tolerated dose has been exceeded and the next lower TMLI dose (Dose Level -1, 1100 cGy) will be expanded to up to 6 patients. If 0 or 1 patient out of 6 experiences a dose-limiting toxicity, this dose level will be further evaluated (n=28 additional patients). If ≥2/6 patients experience a dose-limiting toxicity, the next lower dose (Dose Level -2, 1000 cGy) level will be expanded applying the same criteria.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Antonio Pérez Simón, Hematologist, Principal investigator, Hematology Department, Virgen del Rocío University Hospital, Seville)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602323
- Sponsor's protocol ID
- TMLI-RI
- Other IDs
- 2024-514483-11-00
- Acronym
- TMLI-RI
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Total Marrow and Lymphoid Irradiation (TMLI) Administered in Combination With a Reduced-intensity Regimen Based on Fludarabine and Melphalan as Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT) in Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia.
- ClinicalTrials.gov ID
- NCT06602323
- Acronym / sponsor ID
- TMLI-RI / TMLI-RI
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Keywords
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this clinical trial is to learn if drugs (fludarabine and melphalan) combinated with a targeted irradiation (in bone marrow and in lymphoid tissue) works to treat blood cancers (high risk myelodysplastic syndrome or acute myeloid leukemia) in adults. It will also learn about the safety of this combination of drugs and irradiation. The main questions it aims to answer are:
- Does this combined therapy result in an improved survival and decreased relapse/progression rate after a bone marrow transplant?
- What toxicities or complications do participants have when taking this combined therapy?
Researchers will use this combined therapy to see if it works to treat high risk myelodysplastic syndrome or acute myeloid leukemia through the evaluation of the length of time (during the treatment and 2 years after the treatment) that a patient lives with the disease but it does not get worse (progression-free survival).
Participants will:
- Receive the combined therapy (study treatment) one week before the bone marrow transplant.
- Receive too post-transplant medication as per usual clinical practice.
Patients will have to attend medical visits (checkups and tests) for 2 years.
Detailed description
This is a single-arm, single center phase II trial to evaluate the antileukemic activity and safety of the AHSCT TMLI/Flu/Mel conditioning regimen in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia. A patient safety-lead phase will be carried out to ensure there are no unexpected toxicities. Ultimately, a total of 34 patients will be treated at the TMLI/Flu/Mel dose level deemed safe as determined during the introductory patient safety segment of this study.
Up to three dose levels can be studied. A 3+3 de-escalation design comprising a patient safety-lead phase will be applied in successive patient cohorts to evaluate the safety of the TMLI schedule and identify the optimal treatment dose:
Initially, 3 patients will be treated at the starting TMLI dose (Dose Level 1, 1200 cGy). If 0 or 1 DLT is observed among the first 6 patients at Dose Level 1, then 28 additional patients will be treated at this dose level (allowing for the evaluation of 34 patients treated at the target dose level). If ≥2/6 patients experience a DLT at Dose Level 1, then the MTD has been exceeded and the next lower TMLI dose (Dose Level -1, 1100 cGy) will be expanded to up to 6 patients. If 0 or 1 patient out of 6 experiences a DLT, this dose level will be further evaluated (n=28 additional patients). If ≥2/6 patients experience a DLT, the next lower dose (Dose Level -2, 1000 cGy) level will be expanded applying the same criteria. No further dose level reductions will be allowed beyond Dose Level -2.
No more than 3 patients may be \<30 days after stem cell infusion at any time during patient safety introduction. The tacrolimus dose and MMF dose will remain fixed for all defined dose levels and will not be reduced at any time.
Considering this proposed design, the expected sample size of the study will be n=34 patients, with a potential minimum and maximum size of n=34 and n=46, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 3+3 de-escalation design comprising a patient safety-lead phase will be applied in successive patient cohorts: Initially, 3 patients will be treated at the starting TMLI dose (Dose Level 1, 1200 cGy). If 0 or 1 dose-limiting toxicity is observed among the first 6 patients at Dose Level 1, then 28 additional patients will be treated at this dose level (allowing for the evaluation of 34 patients treated at the target dose level). If ≥2/6 patients experience a dose-limiting toxicity at Dose Level 1, then the maximum tolerated dose has been exceeded and the next lower TMLI dose (Dose Level -1, 1100 cGy) will be expanded to up to 6 patients. If 0 or 1 patient out of 6 experiences a dose-limiting toxicity, this dose level will be further evaluated (n=28 additional patients). If ≥2/6 patients experience a dose-limiting toxicity, the next lower dose (Dose Level -2, 1000 cGy) level will be expanded applying the same criteria.
| Arm | Type | Receives |
|---|---|---|
| TMLI/Flu/Mel conditioning regimen (Single-arm) | Other | Combination Product: TMLI/Flu/MelSingle-arm. TMLI: Dose level 1: 1200 cGy = 150 cGy x 8 doses (liver, brain, and hepatic portal limited to 720 cGy) Dose level -1: 1100 cGy = 137.5 cGy x 8 doses (liver, brain, and hepatic portal limited to 720 cGy) Dose level -2: 1000 cGy = 125 cGy x 8 doses (liver, brain, and hepatic portal limited to 720 cGy) Dose levels above 1,200 cGy will not be considered in this protocol, as the dose to off-target avoidance organs would exceed the recommended levels in reduced-intensity transplants. TMLI will be administered by helical tomotherapy for 4 consecutive days (day -7 to day -4), delivering 2 fractions per day (a total of 8 doses) with a minimum of 6 hours between fractions. FLURADABINE: Dose: 25 mg/m2 Route of administration: intravenous. Treatment duration: for 4 consecutive days (day -7 to day -4 pre-transplant). MELPHALAN: Dose: 140 mg/m2 Route of administration: intravenous Treatment duration: for 1 day (day -2 pre-transplant). |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The participant has the ability and willingness to sign the informed consent document. (For adults, only participants with mild cognitive abilities may use a legally authorized representative).
- Documented (signed) informed consent. The patient, family member, and doctor of the transplant staff (doctor, nurse, and social worker) meet at least once before the transplant procedure begins. During this meeting, all relevant information regarding the risks and benefits to the donor and recipient will be presented. Alternative treatment modalities will be discussed. The risks are explained in detail in the attached consent forms.
- Age: ≥ 50 years or Haematopoietic Cell Transplantation-Comorbidity Index pre-transplant score ≥ 3 or any other condition that precludes the use of a fully myeloablative conditioning regimen.
- Karnofsky's performance status ≥ 70%.
- Patients with myelodysplastic syndrome/acute myeloid leukemia or acute myeloid leukemia with relapsed/refractory active disease (i.e. ≥5% bone marrow blasts), or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing (in the case of fms-like tyrosine kinase-3 internal tandem duplication-mutated AML).
Key exclusion criteria (10 listed)
- Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded.
- Previous radiation therapy which would preclude the use of TMLI.
- Plans during the trial to receive any other investigational (non-trial-related) agents.
- Uncontrolled disease, including ongoing or active infection.
- History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide.
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 |
|---|---|---|
| TMLI/Flu/MelTargeted total bone marrow and lymphoid irradiation (TMLI) conformal therapy administered in combination with a reduced-intensity regimen based on Fludarabine and Melphalan. | Combination product | TMLI/Flu/Mel conditioning regimen (Single-arm) |
Primary outcome
Progression-free survival
Time frame: From the start of therapy to 2 years after study treatment
Time from the start of treatment to the date of death, disease relapse/progression, or date of last follow-up.
9 secondary outcomes
Overall survival
Time frame: From the start of therapy to 2 years after post-transplant.
Cumulative incidence of recurrence/progression
Time frame: From the start of therapy to 2 years after post-transplant.
Complete remission date
Time frame: From the day of infusion to the day 30 post-transplant.
Non-relapse mortality
Time frame: From the start of therapy until 2 years after post-transplant.
Measurable residual disease
Time frame: At 30, 90, 180 days and 1 year, 1.5 years and 2 years post-transplant.
Incidence of infection
Time frame: 2 years after post-transplant.
Adverse events
Time frame: 2 years after post-transplant.
Acute graft-versus-host disease grades 2-4 and 3-4
Time frame: 100 days post-transplant.
Chronic graft-versus-host disease
Time frame: 2 years after post-transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
José Antonio Pérez Simón, Hematologist principal investigator
Hematology Department, Virgen del Rocío University Hospital, Seville)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMLI/Flu/Mel in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
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 16 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Mª Rosso Fernández (+34 955013428, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From the start of therapy to 2 years after study treatment). 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 19 Sep 2024.