PonaZero = Effect of Consolidation Treatment with Ponatinib on TFR Rate [Spain]

Study title

PonaZero = Effect of Consolidation Treatment with Ponatinib on Treatment-free Remission Rate in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) with Deep Molecular Response

Scientific title

Multicenter, open-label, randomized phase III pilot study to evaluate the effect of a one-year consolidation treatment with ponatinib at two-dose ranges on free-remission rate in patients with Philadelphia-positive chronic myeloid leukemia, who had previously achieved a deep molecular response (EudraCT no. 2017-004565-27, ClinicalTrials.gov NCT04043676)

Indication and most important inclusion criteria

This study includes patients who:
- have BCR-ABL positive chronic myeloid leukemia in chronic phase (CP-CML)
- have been on imatinib treatment for a minimum of 4 years with confirmed stable deep molecular response (MR4) for a minimum of 12 months prior to enrolment
- are at least 18 years old
- have not had a prior accelerated phase/blast crisis (AP/BC) or stem cell transplant (SCT)
- have an Eastern Co-Operative Group (ECOG) status of 0-2

Short description of intervention

This is a pilot study to determine the rate of successful treatment-free remission (TFR) in patients who achieved and maintained molecular response 4 (MR4) on ponatinib following at least 4 years of imatinib therapy. Patients who maintain MR4 during the 52-week ponatinib onsolidation phase can attempt stopping ponatinib and will continue in the 104-week TFR phase.

Type of study

7. Treatment discontinuation trials

Current status

Recruiting

Study sponsor

FUNDACIÓN TEÓFILO HERNANDO, Edificio Claid
Parque Científico de Madrid
Calle Faraday, 7, Campus de Cantoblanco, 28049 Madrid

Scientific lead / contact

Gutierrez, Garcia

Principal investigator

Multiple

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Spain

Badalona, Barcelona, 08916
Hospital Trials i Pujol
Dr. Blanca Xicoy

Barcelona, 08035
Hospital Vall D'Hebron
Dr. Guillermo Orti

Las Palmas De Gran Canaria, 35010
Hospital Universitario de Gran Canarias Dr. Negrin
Dr. Maria Teresa Gomez

Madrid, 28006
Hospital Unversitario de la Princesa
Juan Luis Steegmann, MD PhD

Madrid, 28034
Hospital Universitario Ramon y Cajal
Valentin Garcia Gutierrez, MD PhD

Madrid, 28041
Hospital Universitario Doce de Octubre
Rosa Ayala, MD PhD

Málaga, 29010
Hospital Regional de Malaga
Dr. Antonio Jimenez

Salamanca, 37007
Hospital Universitario de Salamanca
Fermin Sanchez-Guija, MD PhD

Valencia, 46010
Hospital Clinico Universitario de Valencia
Dr. Juan Carlos Hernandez Boluda



 

ResToP = Reinduction and Second Stop of TKI With Ponatinib in CML [Spain]

Study title

ResToP = Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response

Scientific titleStudy to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response

Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP) (ClinicalTrials.gov no. NCT04160546, EudraCT no. 2018-003281-14)

Indication and most important inclusion criteria

This study includes patients who:

- are at least 18 years old
- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have been diagnosed with BCR-ABL positive and Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CP-CML)
- lost deep molecular response (MR4) after a first attempt of stopping tyrosine kinase inhibitor (TKI) treatment, restarted TKI again and then regained and maintained confirmed MR4 for more than one year
- have adequate end organ function

Other criteria may apply.

Short description of intervention

In this study, patients will be treated with ponatinib 15 mg/day plus acetyl salicylic acid (ASA) 100 mg/day for 104 weeks. After that, ponatinib and ASA will be stopped.

The study will determine the rate of successful treatment-free remission (TFR) within the first 52 weeks after stopping ponatinib treatment in patients who achieved MR4.

Type of study

7. Treatment discontinuation trials

Current status

Recruiting

Study sponsor

Fundacion CRIS de Investigación para Vencer el Cáncer

in collaboration with:

Incyte Biosciences UK
Apices Soluciones S.L.

Scientific lead / contact

Ana Moreno
Apices Soluciones S.L.

Principal investigator

Joaquín Martínez López, MD
Hospital Universitario 12 de Octubre

Valentín García Gutierrez, MD
Hospital Universitario Ramon y Cajal

Juan Carlos Hernández Boluda, MD
Hospital Clínico de Valencia

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Spain

Badalona
Institut Català d´oncologia Badalona (ICO)
Contact: Blanca Xicoy

Barcelona
Institut Català D'Oncologia L'Hospitalet (ICO)
Principal Investigator: Concepción Boqué Genovard, MD

Las Palmas
Hospital Universitario de Gran Canaria Dr. Negrín
Contact: María Teresa Gómez Casares

Madrid
Hospital General Universitario Gregorio Marañón
Contact: Santiago Osorio Prendes, MD

Hospital Universitario 12 de Octubre
Contact: Rosa Ayala

Hospital Ramón y Cajal
Contact: Valentín García Gutierrez

Hospital Universitario La Paz
ontact: Raquel De Paz

Murcia
Hospital General Universitario J.M. Morales Meseguer
Contact: Francisca Ferrer Martín

Málaga
Complejo Hospitalario Regional de Málaga
Contact: Antonio Jiménez Velasco

Málaga
Hospital Virgen de La Victoria
Contact: Ana Isabel Rosell Mas

Salamanca
Hospital Universitario de Salamanca
Contact: Fermín Sánchez-Guijo Martín

Valencia
Hospital Clínico Universitario de Valencia
Contact: Juan Carlos Hernández Boluda

Hospital Universitario y Politécnico La Fe
Contact: Elvira Mora Casterá, MD

DANTE = A study of full treatment-free remission in patients with CML treated with nilotinib [Italy]

Study title

DANTE (CAMN107AIT15) = A study of full treatment-free remission in patients with chronic myeloid leukemia treated with nilotinib

Scientific title

A Phase II, Single-arm, Multicenter Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase Treated With Nilotinib in First-line Therapy Who Have Achieved a Sustained, Deep Molecular Response for at Least 1 Year (EudraCT 2018-002898-21, ClinicalTrials.gov NCT03874858)

Indication and most important inclusion criteria

This study includes male or female patients 18 years and older with CML in chronic phase who have been receiving first line treatment with nilotinib at 300 mg twice daily for at least 3 calendar years. At study entry, an ongoing treatment at a dose of ≥400 mg per day is allowed.

Patients can be considered for inclusion if they have had sustained molecular remission (MR4 or better with BCR-ABL results of no more than 0.01% on the international scale (IS) in the last 4 real time quantitative polymerase chain reaction (RQ-PCR) tests which were done at least 3 months but no more than 6 months apart.

To be eligible for inclusion, patients must also have acceptable laboratory values at screening and Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.

Additional criteria may apply.

Short description of intervention

This study is will evaluate the rate of full treatment-free molecular remission at week 96 in CML-CP patients treated with nilotinib at half the standard dose (300 mg once daily) during a consolidation period of 12 months, followed by complete therapy cessation.

The study consists of 4 phases: screening, 48-week nilotinib consolidation phase, 96-week treatment-free remission (TFR) phase and follow up phase.

Patient who lose MMR at any time during the study will be restarted on nilotinib treatment at 300 mg twice daily.

Type of study

Treatment discontinuation trial

Current status

Recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Novartis Pharmaceuticals

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators


Italy

Novartis Investigative Site
Bari, 70124

Novartis Investigative Site
Bologna, 40138

Novartis Investigative Site
Cagliari, 09126

Novartis Investigative Site
Catania, 95123

Novartis Investigative Site
Catanzaro, 88100

Novartis Investigative Site
Firenze, 50134

Novartis Investigative Site
Genova, 16132

Novartis Investigative Site
Milano, 20122

Novartis Investigative Site
Milano, 20162

Novartis Investigative Site
Napoli, 80131

Novartis Investigative Site
Napoli, 80132

Novartis Investigative Site
Novara, 28100

Novartis Investigative Site
Orbassano, 10043

Novartis Investigative Site
Palermo, 90127

Novartis Investigative Site
Palermo, 90146

Novartis Investigative Site
Pescara, 65124

Novartis Investigative Site
Perugia, 06100

Novartis Investigative Site
Pisa, 56126

Novartis Investigative Site
Reggio Emilia, 42123

Novartis Investigative Site
Roma, 00144

Novartis Investigative Site
Roma, 00161

Novartis Investigative Site
Roma, 00168

Novartis Investigative Site
Roma, 00161

Novartis Investigative Site
Salerno, 84131

Novartis Investigative Site
Siena, 53100

Novartis Investigative Site
Torino, 10126

Novartis Investigative Site
Torino, 10128

Novartis Investigative Site
Perugia, 06100

Novartis Investigative Site
Verona, 37126

HALF = Efficacy and safety of TKI withdrawal after a two-step dose reduction in patients with CML [Czechia]

Study title

HALF (HALF2019) = Efficacy and safety of TKIs' withdrawal after a two-step dose reduction in patients with chronic myeloid leukemia (CML)

Scientific title

A prospective phase II clinical trial evaluating the efficacy and the safety of tyrosine kinase inhibitors withdrawal after a previous two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission (ClinicalTrials.gov NCT04147533)

Indication and most important inclusion criteria

This study includes male or female patients 18 years and older with Ph1-positive and/or BCR-ABL1-positive CML in chronic phase who have been receiving treatment with a tyrosine kinase inhibitor (TKI) for more than 4 years. Treatment of TKI may have been given either in the first line or in the second or other lines for intolerance only. Previous interferon-α treatment is allowed with any treatment effect (intolerance/failure).

Patients can be considered for inclusion if they have been in molecular remission (MR4.0) or better for at least 2 years.

Additional criteria may apply.

Short description of intervention

This study will evaluate the safety and efficacy of stopping treatment with a TKI (imatinib, dasatinib or nilotinib) in patients with CML in deep molecular remission after after the dose has been reduced in two steps: during the first 6 months after study entry by 50% of standard dose; during the second 6 months this already reduced dose will be given every other day; the medication is discontinued then and the patients are followed every month in the first 6 months after withdrawal, every 1.5 month in the next 6 months, and every 3 months in the next 12 months.

Type of study

Treatment discontinuation trial

Current status

Recruiting

Study sponsor

Masaryk University
Žerotínovo náměstí 617/9
601 77 Brno
Czech Republic

Scientific lead / contact

Daniela Zackova, MD, PhD
Dpt. of Internal Medicine Hematology and Oncology
University Hospital Brno
Jihlavska 20
625 00 Brno
Czech Republic
Tel.: +420 53223 3642
E-mail: zackova.daniela@fnbrno.cz

Principal investigator

Daniela Zackova, University Hospital Brno

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

HALF study design

Study centers / principal investigators

Czechia

University Hospital Brno
Jihlavska 20
Brno, 62500
PI: Daniela Zackova, MD, PhD

University Hospital Hradec Kralove
Sokolská 581
Hradec Králové, 50005
PI: Petra Belohlavkova, MD, PhD

University Hospital Olomouc
I. P. Pavlova 185/6
Olomouc, 77900
PI: Prof. Edgar Faber, MD, PhD

University Hospital Ostrava
17. listopadu 1790/5
Ostrava, 70852
PI: Lukas Stejskal, MD

University Hospital Plzen
Edvarda Beneše 1128/13
Plzen, 30599
PI: Michal Karas, MD, PhD

University Hospital Kralovske Vinohrady
Šrobárova 1150/50
Praha 10, 10034
PI: Olga Cerna, MD

Insitute of Hematology and Blood Transfusion
U Nemocnice 2094/1
Praha 2, 12800
PI: Hana Klamova, MD, PhD

General University Hospital in Prague
U nemocnice 2
Praha 2, 12808
PI: Eduard Cmunt, MD, PhD

TOKIN = TKI cessation for CML patients with stable molecular response in a real world population [USA]

Study title

TOKIN = Efficacy and safety of TKI cessation for CML patients with stable molecular response in a real world population

Scientific title

Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population (ClinicalTrials.gov NCT04626024)

Indication and most important inclusion criteria

This study includes male or female patients 18 years and older with Ph1-positive and/or BCR-ABL1-positive CML with evidence of a quantifiable BCR-ABL1 transcript in real time polymerase chain reaction (RT-PCR) tests.

Patients who have been taking a tyrosine kinase inhibitor (TKI) for more than 36 months can be considered for inclusion .

Eligible patients have been in stable complete molecular remission (MR4.5) or better for at least 2 years, as documented by at least 3 separate tests performed at least 3 months apart.

Additional criteria may apply.

Short description of intervention

This study will evaluate the safety and efficacy of stopping treatment with a TKI (imatinib, dasatinib, nilotinib or bosutinib) in patients with CML in stable molecular remission in a real world population. Treatment with TKI is discontinued within 7 days of study registration. Patients have a BCR-ABL1 test every month for 24 months.

Type of study

Treatment discontinuation trial

Current status

Recruiting

Study sponsor

Baylor College of Medicine

Scientific lead / contact

Martha Mims, MD, PhD,
Baylor College of Medicine,
Houston, Texas

Principal investigator

Martha Mims, MD, PhD,
Baylor College of Medicine,
Houston, Texas

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study centers / principal investigators

United States

Texas

Baylor College of Medicine
Martha Mims, MD, PhD,
Houston, Texas, 77030

Ben Taub General Hospital
Martha Mims, MD, PhD
Houston, Texas, 77030

CHI St. Luke's Health Baylor College of Medicine Medical Center
Martha Mims, MD, PhD
Houston, Texas, 77030

Harris Health System- Smith Clinic
Martha Mims, MD, PhD
Houston, Texas, 77054

 

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