Clinical trial · Interventional
IPI-145 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With IPI-145
NCT02028039CI-TRIAL-00013309withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follow-up Visit/Call | Behavioral | — | UNRESOLVED |
| IPI-145 | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IPI-145
- description
- IPI-145 given at dose of 75 mg orally twice daily for 4 weeks. Courses repeated about every 4 weeks (range 4-6 weeks).
- interventionNames
- Drug: IPI-145
- Behavioral: Follow-up Visit/Call
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 60 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 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. 3. Zubrod performance status 0-3. 4. 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. 5. 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). Exclusion Criteria: 1. Patient with active heart disease (NYHA class \>/= 3 as assessed by history and physical examination). 2. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 45% are excluded. 3. 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. 4. Prior allogeneic stem cell transplant in previous 3 months. 5. Peripheral lymphoblasts \> 50 x 109/L. 6. Pregnant and breast-feeding patients are excluded. 7. Patients with known hepatitis B or C are excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.