Acute Promyelocytic LeukemiaPhase 4NCT00504764
Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
A Phase 4 study testing Arsenic Trioxide, Autologous Transplantation and Allogenic Transplantation in people with Acute Promyelocytic Leukemia, run by PETHEMA Foundation at 86 sites in Spain.
Trial summary
Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Promyelocytic Leukemia
- What is being tested?
- Arsenic Trioxide, Autologous Transplantation and Allogenic Transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 86 sitesSpain
- Study dates
- Jul 2007to Oct 2014
- Phase
- Phase 4
- 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
- ECOG ≤ 3.
- Patients in first or subsequent hematological or molecular relapse of APL
- Persistence of a positive PCR (positive PCR after 3 consolidation cycles of first line therapy).
- Diagnostic measures Confirmation of relapse by RT-PCR of PML/RARa, cytogenetics, FISH or positive PGM3.
- Age over 18 years (No upper age limit)
- Informed consent of the patient
Who cannot join
- ECOG 4.
- Heart failure NYHA grade III and IV.
- Renal or hepatic failure WHO grade ³III
- Positive HIV.
- Psychological dysfunction
- Associated active neoplasia
Show all 9Show fewer
- Pregnancy.
- Arsenic Hypersensibility.
- QTc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the QT-interval )
Trial locations and contacts
86 sites in 1 country.
86 sites in 1 country
Spain86 sites
Hospital Juan Canalejo
A Coruña, La Coruña
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital de Alcorcón
Alcorcón, Madrid
Fundación Hospital Alcorcón
Alcorcón
Hospital General de Alicante
Alicante, Alicante
Hospital de la Ribera
Alzira
Hospital Ntra. Sra. Sonsoles
Ávila, Avila
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Valle Hebrón
Barcelona, Barcelona
Hospital Clinic
Barcelona
Basurtuko Ospitalea
Basurto
Hospital de Cruces
Bilbao
Complejo Hospitalario de Cáceres
Cáceres
Hospital Puerta del Mar
Cadiz, Cádiz
Hospital general de Castellón
Castelló, Castellón
Complejo Hospitalario Reina Sofía
Córdoba, Córdoba
Hospital Donostia
Donostia / San Sebastian
Hospital General de Elda
Elda
Hospital de Fuenlabrada
Fuenlabrada
Hospital Virgen de las Nieves
Granada, Granada
Hospital General de Guadalajara
Guadalajara
Area Hospitalaria Juan Ramón Jimenez
Huelva
Hospital de San Jorge
Huesca
Hospital Médico Quirúrgico Ciudad de Jaén
Jaén, Jaen
Hospital de Jerez de la Frontera
Jerez de la Frontera
Hospital General de Lanzarote
Lanzarote
Complejo Hospitalario León
León
Hospital Arnau de Vilanova
Lleida, Lleida
Complexo Hospitalario Xeral-Calde
Lugo
Clínica La Concepción
Madrid, Madrid
Clínica Puerta de Hierro
Madrid, Madrid
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
Hospital General Universitario Gregorio Marañón, Madrid
Madrid, Madrid
Clínica Moncloa
Madrid
Clínica Puerta de Hierro
Madrid
Clínica Rúber
Madrid
Fundación Jiménez Díaz
Madrid
Hospital 12 de Octubre
Madrid
Hospital Central de la Defensa
Madrid
Hospital de la Princesa
Madrid
Hospital Doce de Octubre
Madrid
Hospital la Paz
Madrid
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga
Althaia, Xarxa Asistencial de Manresa
Manresa
Fundación Hospital Sant Joan de Déu de Martorell
Martorell
Hospital de Mataró
Mataró, Barcelona
Hospital de Mérida
Mérida
Hospital de Móstoles
Móstoles
Hospital General Morales Meseguer
Murcia
Hospital Central de Asturias
Oviedo, Principality of Asturias
Hospital del Río Carrión
Palencia, Palencia
Hospital de Gran Canaria Doctor Negrín
Palma de Gran Canaria
Hospital Son Dureta
Palma de Mallorca, Palma de Mallorca
Hospital Son Llàtzer
Palma de Mallorca, Palma de Mallorca
Hospital Verge del Toro
Palma de Mallorca
Clínica Universitaria de Navarra
Pamplona, Navarre
Complejo Hospitalario de Pontevedra_Hospital Montecelo
Pontevedra
Complejo Hospitalario de Pontevedra_Hospital Provincial
Pontevedra
Corporació Sanitaria Parc Taulí
Sabadell
Hospital de Sagunto
Sagunto
Hospital Clínico de Salamanca
Salamanca
Clínica Sant Camil
Sant Pere de Ribes
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña
Hospital General de Segovia
Segovia
H.U. Virgen del Rocio
Seville
Hospital Joan XXIII
Tarragona, Tarragona
Hospital Nuestra Señora del Prado
Toledo
Hospital Verge de la Cinta
Tortosa, Tarragona
Hospital Clínic
Valencia, Valencia
Hospital General Universitario
Valencia, Valencia
Hospital La Fe
Valencia, Valencia
Fundación Instituto Valenciano de Oncología
Valencia
Hospital Dr. Peset
Valencia
Hospital Francesc de Borja
Valencia
Hospital Clínico de Valladolid
Valladolid
Hospital Comarcal Pius de Valls
Valls
Complejo Hospitalario Xeral-Cies
Vigo, Vigo
Comarcal de Vinaros
Vinaròs
Hospital Txagorritxu
Vitoria-Gasteiz
Hospital de Galdakao
Vizcaya
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza
Hospital Miguel Servet
Zaragoza
About this study
Official title: APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia.
By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be reached. On average, about 10% of patients still die in the early phase of the treatment and about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the individual kinetics of MRD and to identify patients with an imminent hematological relapse.
Read more
A standardized treatment for patients with relapsed APL has not yet been established. With arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower concentrations. ATO was also successfully administered before allogeneic and autologous transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe and in the USA.
After remission induction, there are several options for postremission therapy Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg
Read the detailed description
Induction ATO 0.15 mg/kg/día IV in continuous perfusion 1-2 hours/day until complete response (CR) or maximum of 60 days.
Oral hydroxyurea treatment (initial dose 2 g/day)is recommended in patients with leucocyte counts at relapse >10x109/L or in the two first weeks of induction.
Isolated molecular relapsed patients will be treated with ATO (same dose) 5 days at week, during 6 weeks.
Consolidation ATO 0.15 mg/kg/día IV 5 days at week, during 5 weeks, combined with oral ATRA 45 mg/m²/day during the same 5 weeks.
Post-consolidation therapy TPH (autologous or allogenic) in candidate patients. In case of molecular remission, is recommended autologous-TPH.
Patients no candidates to auto-TPH or alo-TPH, should will follow treatment with ATO cycles + ATRA +/- Mylotarg.
- Option Alo-TPH If PCR post-consolidation is negative is recommended auto-TPH. However, if alo-TPH is decided, it will be done immediately without preceding chemotherapy. If PCR post-consolidation is positive, should done alo-TPH.
- Option Auto-TPH If PCR post-consolidation is negative it will be administered one cycle of MTZ + Ara-C follow by auto-TPH. In cas of failure: a) if patient has autologous stem cells preserved (PCR negative) are suitable for auto-TPH; b) patients with HLA-compatible donor who are suitable for allogenic stem cell transplantation should be transplanted; c) Patients who are not eligible for allogenic or autologous transplantation, receive various cycles with ATO + ATRA combined or not with Mylotarg. If PCR post-consolidation is positive and patient is eligible for allogenic TPH, should be done a allogenic TPH. If patient is no eligible for allogenic TPH or dont has compatible donor, will be administrate one cycle of MTZ + Ara-C and collect stem cells. Autologous transplantation will be done if after this cycle, a molecular remission is obtained. No molecular remission or no enough stem cells collection, patient follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg.
- ATO + ATRA combined or no with Mylotarg Patients no eligible to autologous TPH or allogenic TPH follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg.
If Mylotarg is no possible, treatment will be with subsequent cycles of ATO + ATRA.
ATO + ATRA + Mylotarg: Mylotarg 6 mg/m2 day 1, ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15. Doses of mylotarg should be reduced to 3 mg/m2 in patients aged over 60 years. Administration of 3 cycles with a month interval, follow of 3 to 6 cycles of ATO + ATRA without Mylotarg. After, ATRA 45 mg/m2/d 15 days every 3 months until complete two years of maintenance.
ATO + ATRA: ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15, every 29 days. Administration of 9 cycles, and followed by ATRA 45 mg/m2/d during 15 days every 3 months until complete two years of maintenance.
- Conditions
- Acute Promyelocytic Leukemia
- Being tested
- Arsenic Trioxide, Autologous Transplantation, Allogenic Transplantation, ATRA
- Keywords
- Relapsed Acute Promyelocytic Leukemia, Arsenic Trioxide
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
Induction ATO 0.15 mg/kg/day IV until CR or a maximum of 60 days In isolated molecular relapse ATO will be administered at same dose, 5 days a week, during 6 weeks.
Consolidation ATO 0.15 mg/kg/day IV 5 days week, during 5 weeks
Autologous TransplantationProcedure or surgery
Autologous Transplantation
Allogenic TransplantationProcedure or surgery
Allogenic Transplantation
ATRADrug
Consolidation: ATRA 45 mg/m²/day oral during 5 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the hematological and molecular remission rate after induction and consolidation with ATO
Measured: 1 year
Evaluate the induction mortality with ATO in monotherapy
Measured: 1 year
Evaluate the hematological and molecular relapse rate in patients treated with autologous transplantation, allogenic transplantation or ATO + ATRA +/- Mylotarg
Measured: 1 year
Secondary outcomes (4)
Evaluate kinetics of the MDR of PML/RARa during and after ATO
Measured: 2 years
Evaluate the mortality related with postremission treatment
Measured: 1 year
Side effects of ATO and the different treatments post-consolidation
Measured: 2 years
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanz Miguel Angel, Dr, Study chair, Hospital La FeEsteve Jordi, Dr, Study chair, Hospital Clinic of BarcelonaMontesinos Pau, Dr, Study chair, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504764
- Sponsor's protocol ID
- LAP-R2007
- Status last verified
- Oct 2014
- First submitted
- 19 Jul 2007
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APL-R2007: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
- ClinicalTrials.gov ID
- NCT00504764
- Acronym / sponsor ID
- LAP-R2007
- Conditions
- Acute Promyelocytic Leukemia
- Keywords
- Relapsed Acute Promyelocytic Leukemia, Arsenic Trioxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jul 2007 (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.
Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia.
By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be reached. On average, about 10% of patients still die in the early phase of the treatment and about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the individual kinetics of MRD and to identify patients with an imminent hematological relapse.
A standardized treatment for patients with relapsed APL has not yet been established. With arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower concentrations. ATO was also successfully administered before allogeneic and autologous transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe and in the USA.
After remission induction, there are several options for postremission therapy Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg
Detailed description
Induction ATO 0.15 mg/kg/día IV in continuous perfusion 1-2 hours/day until complete response (CR) or maximum of 60 days.
Oral hydroxyurea treatment (initial dose 2 g/day)is recommended in patients with leucocyte counts at relapse >10x109/L or in the two first weeks of induction.
Isolated molecular relapsed patients will be treated with ATO (same dose) 5 days at week, during 6 weeks.
Consolidation ATO 0.15 mg/kg/día IV 5 days at week, during 5 weeks, combined with oral ATRA 45 mg/m²/day during the same 5 weeks.
Post-consolidation therapy TPH (autologous or allogenic) in candidate patients. In case of molecular remission, is recommended autologous-TPH.
Patients no candidates to auto-TPH or alo-TPH, should will follow treatment with ATO cycles + ATRA +/- Mylotarg.
- Option Alo-TPH If PCR post-consolidation is negative is recommended auto-TPH. However, if alo-TPH is decided, it will be done immediately without preceding chemotherapy. If PCR post-consolidation is positive, should done alo-TPH.
- Option Auto-TPH If PCR post-consolidation is negative it will be administered one cycle of MTZ + Ara-C follow by auto-TPH. In cas of failure: a) if patient has autologous stem cells preserved (PCR negative) are suitable for auto-TPH; b) patients with HLA-compatible donor who are suitable for allogenic stem cell transplantation should be transplanted; c) Patients who are not eligible for allogenic or autologous transplantation, receive various cycles with ATO + ATRA combined or not with Mylotarg. If PCR post-consolidation is positive and patient is eligible for allogenic TPH, should be done a allogenic TPH. If patient is no eligible for allogenic TPH or dont has compatible donor, will be administrate one cycle of MTZ + Ara-C and collect stem cells. Autologous transplantation will be done if after this cycle, a molecular remission is obtained. No molecular remission or no enough stem cells collection, patient follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg.
- ATO + ATRA combined or no with Mylotarg Patients no eligible to autologous TPH or allogenic TPH follows treatment with subsequent cycles of ATO + ATRA combined or no with Mylotarg.
If Mylotarg is no possible, treatment will be with subsequent cycles of ATO + ATRA.
ATO + ATRA + Mylotarg: Mylotarg 6 mg/m2 day 1, ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15. Doses of mylotarg should be reduced to 3 mg/m2 in patients aged over 60 years. Administration of 3 cycles with a month interval, follow of 3 to 6 cycles of ATO + ATRA without Mylotarg. After, ATRA 45 mg/m2/d 15 days every 3 months until complete two years of maintenance.
ATO + ATRA: ATO 0.15 mg/kg days 1 to 5 and 8 to 12, and ATRA 45 mg/m2/d days 1 to 15, every 29 days. Administration of 9 cycles, and followed by ATRA 45 mg/m2/d during 15 days every 3 months until complete two years of maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG ≤ 3.
- Patients in first or subsequent hematological or molecular relapse of APL
- Persistence of a positive PCR (positive PCR after 3 consolidation cycles of first line therapy).
- Diagnostic measures Confirmation of relapse by RT-PCR of PML/RARa, cytogenetics, FISH or positive PGM3.
- Age over 18 years (No upper age limit)
Key exclusion criteria (9 listed)
- ECOG 4.
- Heart failure NYHA grade III and IV.
- Renal or hepatic failure WHO grade ³III
- Positive HIV.
- Psychological dysfunction
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 |
|---|---|---|
| Arsenic TrioxideInduction ATO 0.15 mg/kg/day IV until CR or a maximum of 60 days In isolated molecular relapse ATO will be administered at same dose, 5 days a week, during 6 weeks. Consolidation ATO 0.15 mg/kg/day IV 5 days week, during 5 weeks | Drug | – |
| Autologous TransplantationAutologous Transplantation | Procedure or surgery | – |
| Allogenic TransplantationAllogenic Transplantation | Procedure or surgery | – |
| ATRAConsolidation: ATRA 45 mg/m²/day oral during 5 weeks | Drug | – |
Primary outcome
Evaluate the hematological and molecular remission rate after induction and consolidation with ATO
Time frame: 1 year
Evaluate the induction mortality with ATO in monotherapy
Time frame: 1 year
Evaluate the hematological and molecular relapse rate in patients treated with autologous transplantation, allogenic transplantation or ATO + ATRA +/- Mylotarg
Time frame: 1 year
4 secondary outcomes
Evaluate kinetics of the MDR of PML/RARa during and after ATO
Time frame: 2 years
Evaluate the mortality related with postremission treatment
Time frame: 1 year
Side effects of ATO and the different treatments post-consolidation
Time frame: 2 years
Overall survival
Time frame: 2 years
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 28 Oct 2014.
- Spanish association of HaematologyLink provided by the sponsor.
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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.
Sanz Miguel Angel, Dr study chair
Hospital La Fe
Esteve Jordi, Dr study chair
Hospital Clinic of Barcelona
Montesinos Pau, Dr study chair
Hospital General Universitario de Valencia
86 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arsenic Trioxide, Autologous Transplantation and Allogenic Transplantation in people with Acute Promyelocytic Leukemia, run by PETHEMA Foundation at 86 sites in Spain.
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 6 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the hematological and molecular remission rate after induction and consolidation with ATO (time frame: 1 year). The study lists 3 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 28 Oct 2014.