NCT02028039

Brief Summary

The goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

January 3, 2014

Last Update Submit

January 3, 2014

Conditions

Leukemia

Keywords

LeukemiaRefractory Acute Lymphoblastic LeukemiaALLBurkitt's lymphomaLymphoblastic lymphomaIPI-145

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Primary endpoint for efficacy is overall response rate (ORR) defined as complete remission (CR), complete remission without recovery of counts (CRi), or partial remission (PR). Overall response evaluated at the end of the first two cycles.

    60 days

Study Arms (1)

IPI-145

EXPERIMENTAL

IPI-145 given at dose of 75 mg orally twice daily for 4 weeks. Courses repeated about every 4 weeks (range 4-6 weeks).

Drug: IPI-145Behavioral: Follow-up Visit/Call

Interventions

IPI-145DRUG

75 mg orally twice daily for 4 weeks.

IPI-145
Follow-up Visit/CallBEHAVIORAL

Follow-up visit 30 days after last dose of study drug. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes.

IPI-145

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previously treated ALL (including Burkitt's lymphoma, lymphoblastic lymphoma) in relapse or primary refractory. Patients with ALL or B or T cell origin may be treated. Patients in first relapse will be eligible regardless of the first remission duration. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely.
  • Age 16 years or older. Pediatric patients (\<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
  • Zubrod performance status 0-3.
  • Adequate liver function (bilirubin \</= 1.5 mg/dL and SGPT or SGOT \</= 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (creatinine \</= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \</= 2.0 mg/dL and creatinine \</= 3 mg/dL.
  • Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as \> 1 year postmenopausal or surgically sterilized).

You may not qualify if:

  • Patient with active heart disease (NYHA class \>/= 3 as assessed by history and physical examination).
  • Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 45% are excluded.
  • Patients who receive other chemotherapy. Patients must have been off previous therapy for \>/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system \[CNS\] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the Principal Investigator.
  • Prior allogeneic stem cell transplant in previous 3 months.
  • Peripheral lymphoblasts \> 50 x 109/L.
  • Pregnant and breast-feeding patients are excluded.
  • Patients with known hepatitis B or C are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt Lymphoma

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Study Officials

  • Susan O'Brien, MD, BA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 6, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Last Updated

January 6, 2014

Record last verified: 2014-01