REALIB-LLA-2017: Idelalisib in Patients With Acute Lymphoblastic Leukemia

NCT03742323 | Terminated Phase 1

• 1 other identifier: REALIB-LLA-2017
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 12

Brief Summary

This study will attempt to confirm the hypothesis that Idelalisib may represent a new therapeutic alternative for patients with ALL in a set of particularly complex scenarios: relapsed, refractory to conventional treatments, and old age. For this reason, the primary objective is the overall response rate \[ORR, defined as complete response (CR) or CR with partial hematologic recovery (CRh) and response duration (RD) in adult patients with relapsed or refractory ALL, or in adult ALL patients who are not suitable for treatment with conventional therapies.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  overall response rate (ORR), defined as CR (blasts in bone marrow aspiration \<5%; neutrophils \>1x109/L and platelets\>100x109/L in peripheral blood) or CR with partial hematologic recovery (RCh) (blasts in bone marrow aspiration \<5%; neutrophils\<1x109/L and/or platelets \<100x109/L in peripheral blood).

  6 months

• Response duration

  Time to response duration

  6 months

Secondary Outcomes (4)

• Overall Response Rate in subgroups

  6 months

• Determine progression free survival (PFS).

  6 months

• Determine overall survival (OS).

  24 months

• Percentage of Adverse Events

  6 months

Study Arms (1)

Idelalisib

EXPERIMENTAL

Drug: Idelalisib

Interventions

Idelalisib DRUG

Idelalisib Dose: 100, 150, 200 or 300 mg (in four cohorts of six patients each).

Also known as: CAL-101

Idelalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• B-cell precursor ALL, in any of the following cases:
• Second or subsequent relapses \[including after hematopoeitic stem cell transplantation (HSCT)\] in patients who are ineligible for subsequent HSCT.
• Resistance to at least two lines of treatment. Line of treatment is understood as initial treatment y salvage therapy after the first relapse (that may include HSCT).
• Older adult patients (aged \>65 years) for whom standard therapies are not clinically advisable.
• In patients with Ph+ ALL, failure after receiving at least two treatments with different TKIs (tyrosine kinase inhibitors): imatinib, dasatinib or ponatinib, in patients who are ineligible for subsequent HSCT.
• ECOG between 0 and 2.
• Aspartate transaminase (AST) and alanine aminotransferase (ALT) values \< two times the upper limit of normal (ULN) and total bilirubin 2 mg/dL.
• Creatinine \<2 mg/dL
• More than 10% blasts in bone marrow in the two weeks prior to the start of the trial.
• Women of childbearing potential: must agree to practice abstinence (abstain from having heterosexual sexual relations/contact) or to use one highly effective birth control method (failure rate less than 1%) during the treatment period and for at least 28 day after the last dose of Idelalisib .
• A woman is considered able to conceive if she is menstruating, is not post-menopausal (≥12 consecutive months without menstruation for no cause other than menopause) and who has not undergone surgical sterilization (removal of ovaries or uterus).
• Examples of birth control methods with a \<1% yearly failure rate include bilateral tubal ligation, vasectomy, proper use of hormonal contraceptives that prevent ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• The feasibility of sexual abstinence should be evaluated with respect to the duration of the trial and the patient's normal lifestyle preferences. Periodic abstinence (for example, the calendar method, ovulation, symptothermal or post-ovulation methods) and the withdrawal method are not acceptable birth control methods.
• Male patients: must agree to practice abstinence (abstain from heterosexual sexual relations) or use birth control methods, and agree to not donate sperm, as defined below:

You may not qualify if:

• Isolated central nervous system relapse.
• Patients planning to undergo HSCT.
• Grade II-IV active diarrhea.
• Grade II-IV active liver toxicity.
• Previous treatment with other PI3K/mTOR inhibitors.
• Taking any other experimental drug at the time of entering the trial. Patients who have completed a 4-week washout period will be permitted to enrol in the trial.
• Taking any antineoplastic drugs at the time of entering the trial (an exception is made for patients being treated with hydroxyurea or glucocorticoids. Use of these drugs is allowed up to 24 hours before initiating treatment with Idelalisib ).
• Patients being treated with moderate or potent CYP3A4 inhibitors or inducers.
• Patients with Stevens-Johnson Syndrome and toxic epidermal necrolysis.
• Patients with active chronic hepatitis, including viral hepatitis.
• Patients with HIV.
• Medical history of pneumonitis or any baseline lung disorder that, in the investigator's opinion, might worsen the patient's prognosis in the event of opportunistic pneumonia

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (12)

Hospital ICO Badalona

Badalona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Vall d'Hebrón

Barcelona, Spain

Location

Hospital ICO Hospitalet

L'Hospitalet de Llobregat, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

H. Virgen de la Victoria

Málaga, Spain

Location

H. Morales Meseguer

Murcia, Spain

Location

Hospital Clinico de Salamanca

Salamanca, Spain

Location

Hospital Marques de Valdecilla

Santander, Spain

Location

H. Universitario Virgen de Rocío

Seville, Spain

Location

Hospital Clínico Valencia

Valencia, Spain

Location

Hospital Universitario y Politécnico la Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: July 1, 2018
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

ES (12)