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Acute Lymphoblastic LeukemiaPhase 1/2NCT03742323

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

A Phase 1/2 study testing Idelalisib in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 12 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Idelalisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
12 sitesSpain
Study dates
1 Jul 2018to 2 Jun 2020
Phase
Phase 1/2
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

  • 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.
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  • 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:
  • With female partners of childbearing capacity or pregnant female partner, men must practice total abstinence or use a condom plus one additional birth control method which, combined, have a failure rate of <1% per year during the treatment period, and for at least 4 months after the last dose of Idelalisib to avoid exposure to the fetus. Men must not donate sperm during this same time period.
  • The feasibility of sexual abstinence should be evaluated with respect to the duration of the trial and the patient's lifestyle preferences. Periodic abstinence and the withdrawal method are not acceptable birth control methods.

Who cannot join

  • Isolated central nervous system relapse.
  • Patients planning to undergo HSCT.
  • Any active systemic fungal, bacterial, or viral infection at the time of inclusion in the study.
  • Grade II-IV active diarrhea.
  • Grade II-IV active liver toxicity.
  • Previous treatment with other PI3K/mTOR inhibitors.
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites

  • Hospital ICO Badalona

    Badalona

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Vall d'Hebrón

    Barcelona

  • Hospital ICO Hospitalet

    L'Hospitalet de Llobregat

  • Hospital 12 de Octubre

    Madrid

  • H. Virgen de la Victoria

    Málaga

  • H. Morales Meseguer

    Murcia

  • Hospital Clinico de Salamanca

    Salamanca

  • Hospital Marques de Valdecilla

    Santander

  • H. Universitario Virgen de Rocío

    Seville

  • Hospital Clínico Valencia

    Valencia

  • Hospital Universitario y Politécnico la Fe

    Valencia

Other trials in Spain

About this study

Official title: Phase I-II Unmasked, Non-randomized Study Evaluating the Role of Idelalisib in Patients With Acute Lymphoblastic Leukemia (ALL) That is Relapsing or Refractory to Other Treatments, and in Older Patients With ALL for Whom Conventional Treatments Are Not Recommended

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.

Read the detailed description

Phase I-II multi-site, exploratory, interventional, unmasked, non-randomized, single arm clinical trial. A single drug will be administered in four different, increasing doses to four consecutive cohorts.

The first phase of the study will focus on determining the most effective and tolerated dose of the study drug. The second phase will follow patients to the end to evaluate the safety of the drug.

The dose escalation will be decided by the Study Coordinator, who will evaluate and assess each cohort. Once the cohort of 6 patients is complete, the Coordinator will evaluate patients and, based on the tolerability and efficacy obtained, will decide whether to proceed with the dose escalation, or whether to end the trial The study will remain open until the overall number of participants is achieved; §progressive dose increases (PI) will be discontinued if dose-limiting toxicity (DLT) is observed in more than two patients in the previous cohort, *PI of the dose will only continue (for the third cohort) if at least two patients in the first two cohorts achieve the overall response rate (ORR), that is, complete response (CR) at four weeks from initiation of treatment; the study will only move on to the fourth cohort if CR is achieved in at least one of the six patients in the third cohort at four weeks from initiation of treatment; *microscopy/cytofluorometry; **complete blood count, microscopy, biochemistry; ***as long as there is no relapse, treatment will continue after the end of the study (planned for 24 months after the start of recruitment); AE, adverse events

Being tested
Idelalisib
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IdelalisibDrug

    Also called CAL-101

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

Study groups in NCT03742323
Study groupRoleWhat they receive
IdelalisibExperimentalNot described
Receives: Drug: Idelalisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months

  2. Response duration

    Time to response duration

    Measured: 6 months

Secondary outcomes (4)

  1. Overall Response Rate in subgroups

    Determine ORR in distinct subgroups of ALL (Ph+ and Ph-).

    Measured: 6 months

  2. Determine progression free survival (PFS).

    Time to progression

    Measured: 6 months

  3. Determine overall survival (OS).

    Time of overall survival

    Measured: 24 months

  4. Percentage of Adverse Events

    Safety

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start1 Jul 2018
  3. Primary completion2 Jun 2020
  4. Study completion2 Jun 2020

Why it stopped: Because of low recruitment

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742323
Sponsor's protocol ID
REALIB-LLA-2017
Status last verified
Sep 2021
First submitted
13 Nov 2018
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Idelalisib in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 12 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 17 inclusion and 13 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: stopped early, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: Because of low recruitment). Results are not available in the source record.

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?

Overall Response Rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742323.

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 5 Sep 2021.

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