Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

De intervención

Fase

Fase 1 / Fase 2

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

40 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Diagnosis of one of the following:

a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy with or without other TKIs are considered minimally pretreated and still eligible if they have persistently detectable MRD.

i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid blast phase CML
2. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years
3. Weight ≥40kg
4. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):

1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
3. Aspartate aminotransferase (AST) ≤ 3 x ULN
5. Adequate renal function defined as:

a) Creatinine clearance ≥30 mL/min
6. Adequate pancreatic function as defined by the following criteria:

a) Serum lipase and amylase \< 1.5 x ULN
7. Adequate cardiac function as assessed clinically by history and physical examination.
8. For females of childbearing potential, a negative urine pregnancy test must be documented
9. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide
10. Ability to understand and the willingness to sign a written informed consent document.
11. Signed informed consent

Exclusion Criteria:

1. Active serious infection not controlled by oral or intravenous antibiotics.
2. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.
3. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
4. Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
5. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Participants with active CNS leukemia will NOT be excluded)
6. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Cytarabine 2 g/m2 (or alternative) for cytoreduction is permitted.
7. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (2)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

2 centros

Equipo y fechas

Patrocinador principal

M.D. Anderson Cancer Center

Inicio del estudio

5 ago 2024 Real

Finalización primaria

1 may 2027 Estimado

Finalización del estudio

1 may 2029 Estimado

Primera publicación

13 mar 2024 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio