AzTrials
AzTrials

LymphomaPhase 1NCT01871675

Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies

A Phase 1 study testing IPI-145, Rituximab and Bendamustine in people with Lymphoma and Chronic Lymphocytic Leukemia, run by SCRI Development Innovations, LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IPI-145, Rituximab and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
4 sitesUnited States
Study dates
May 2013to Jun 2016
Phase
Phase 1
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

  • Dose Escalation Phase
  • Arm 1 and Arm 2: Limited to subjects diagnosed with low grade CD-20 positive B-Cell NHL with at least one prior anticancer treatment.
  • Dose Expansion Phase
  • Arm 1 Cohort A: Limited to subjects with CD-20 positive CLL with at least one prior anticancer treatment.
  • Arm 1 Cohort B: Limited to subjects with diagnosis of CD-20 positive NHL with at least one prior anticancer treatment.
  • Arm 2 Cohort A: Limited to subjects with CD-20 positive CLL with at least one prior anticancer treatment.
Show all 24Show fewer
  • Arm 2 Cohort B: Limited to subjects with diagnosis of CD-20 positive NHL with at least one prior anticancer treatment.
  • Disease status requirement:
  • CLL subjects: symptomatic disease that mandate treatment;
  • Indolent NHL subjects: symptomatic disease requiring treatment according to the clinical judgment of the investigator;
  • Other lymphoma subjects: disease requiring treatment according to the judgment of the investigator.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤2.
  • Subject must have measurable disease using the disease-specific response criteria for NHL or CLL
  • Age ≥ 18 years.
  • Subject has recovered from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions.
  • Adequate organ system function ≤2 weeks prior to Day 1, defined as follows:
  • Absolute neutrophil count (ANC) ≥1.0 x 109/L unless related to underlying CLL or indolent NHL bone marrow involvement, and then ANC ≥500 x 109/L permitted.
  • Platelets ≥100 x 109/L unless related to underlying CLL or indolent NHL bone marrow involvement, and then platelets ≥75 x 109/L permitted.
  • Subjects receiving IPI-145 plus rituximab with bone marrow involvement may enroll with platelets ≥40 x 109/L.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN and total bilirubin ≤1.5 times the upper limit of normal (ULN) (except for subjects with Gilbert's disease)
  • Serum creatinine ≤1.5 x ULN
  • Life expectancy of ≥12 weeks.
  • Women of child-bearing potential (WCBP) must have a negative serum or urine pregnancy test.
  • Ability to understand the nature of this study and give written informed consent.

Who cannot join

  • Prior allogeneic hematopoietic stem cell transplant (HSCT).
  • Prior autologous transplant or radioimmunotherapy ≤6 months prior to the first dose of trial treatment.
  • Subject has a high grade lymphoma such as Burkitt's, lymphoblastic or small non-cleaved cell lymphomas. Subjects with intermediate grade lymphoma (such as diffuse large B-cell lymphoma) are eligible.
  • Subjects with diffuse B-cell lymphoma must either not be eligible for autologous bone marrow transplant (BMT) or relapsed after autologous BMT.
  • More than three previous cytotoxic chemotherapy regimens for subjects treated on the arm containing bendamustine.
  • Subjects who have had a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies.
Show all 28Show fewer
  • Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), radiation therapy (other than whole brain irradiation [WBI]) surgery or ablative therapy or investigational drugs/devices ≤28 days before first dose of trial treatment.
  • Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 7 days before the first dose of trial treatment.
  • Tyrosine kinase inhibitor within 7 days prior to the first dose of trial treatment.
  • Subjects with overt leptomeningeal leukemia or central nervous system (CNS) lymphoma. Subjects must be free of CNS disease for a minimum of 2 months. Subjects with symptoms of CNS disease must have a negative diagnostic lumbar puncture prior to study enrollment.
  • Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
  • Baseline QTcF >480 ms. Note: This criterion does not apply to subjects with a left bundle branch block.
  • Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:
  • Have been on a stable dose of anticoagulation for <1 month.
  • Have had a Grade 2, 3 or 4 hemorrhages in the last 30 days.
  • Are experiencing continued symptoms for their venous thromboembolic event.
  • Subjects with a history of liver disease as a result of alcohol abuse, chronic hepatitis, or other chronic liver disease (other than metastatic disease to the liver).
  • Subjects with positive HBsAg, HBcAb or HCV are excluded.
  • Subjects with a history of tuberculosis within the preceding two years.
  • Prior surgery affecting drug absorption or any gastrointestinal dysfunction that could alter drug absorption.
  • Subjects with a known hypersensitivity to bendamustine or rituximab.
  • Presence of active infection within 72 hours of treatment. Subjects with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications.
  • Known diagnosis of human immunodeficiency virus (HIV).
  • Concurrent administration of medications or foods that are strong or moderate inhibitors or inducers of CYP3A.
  • Women who are pregnant or lactating.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the subject to be enrolled.
  • Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • The Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Oklahoma University

    Oklahoma City, Oklahoma, 73104

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: An Open-label, Phase Ib Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Select Subjects With Lymphoma or Chronic Lymphocytic Leukemia

The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.

Read the detailed description

This trial consists of two parallel arms. For each treatment arm, a 3+3 dose escalation design will be applied in 3-6 subject cohorts until the maximum tolerated dose of IPI-145 when given with rituximab (Arm 1) or in combination with rituximab and bendamustine (Arm 2) is determined. Treatment arm selection will be chosen by the investigator and will depend on the agents previously administered to the subject. Once the MTD has been determined, the arms will move on to a dose expansion phase. During the dose expansion phase, each treatment arm will enroll to population specific cohorts to assess efficacy. All subjects must have had at least one prior anticancer treatment. The dose expansion cohorts are:

Arm 1: Cohort A - CLL: Cohort B - CD20+ NHL

Arm 2: Cohort A - CLL: Cohort B - CD20+ NHL

Being tested
IPI-145, Rituximab, Bendamustine
Keywords
Lymphoma, Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, T-cell Lymphoma, Rituxan, Bendamustine, Hematologic Malignancy, Relapsed, Refractory
Medical subject headings
Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Hematologic Neoplasms, Recurrence

What participants receive

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

Study groups in NCT01871675
Study groupRoleWhat they receive
Arm 1: IPI-145 plus RituximabExperimentalIPI-145 will be administered orally, twice daily, in 28-day (4-week) cycles, on a continuous basis at the maximum tolerated dose of 25 mg twice-daily (BID), as determined in the dose escalation phase. Twelve (12) cycles of IPI-145 will be administered. Patients who benefit from treatment may continue on study for additional cycles until toxicity or progressive disease. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Day 1 once weekly during a 28 day cycle; 2 cycles of rituximab will be administered.
Receives: Drug: IPI-145; Drug: Rituximab
Arm 2: IPI-145 plus Rituximab/BendamustineExperimentalIPI-145 will be administered orally, twice daily, in 28 day cycles, on a continuous basis, until disease progression, unacceptable toxicity or patient refusal. The maximum tolerated dose of IPI-145 will be 25 mg twice-daily (BID) as determined in the dose escalation phase. Twelve (12) cycles of IPI-145 will be administered. Patients who benefit from treatment may continue on study for additional cycles until toxicity or progressive disease. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Day 1 once weekly of each 28 day cycle. A maximum of 6 cycles of rituximab will be given. Bendamustine 90 mg/m2 IV will be administered on Days 1 and 2, of each 28 day cycle. Rituximab should be administered prior to bendamustine.
Receives: Drug: IPI-145; Drug: Rituximab; Drug: Bendamustine

What is being measured

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

  1. The number of adverse events, serious adverse events, and dose limiting toxicities as a measure of safety and tolerability

    The maximum tolerated dose of IPI-145 defined as the optimal dose at which ≤1 of 6 patients experiences a DLT assessed by NCI CTCAE v4.0.

    Measured: up to 12 months

Secondary outcomes (1)

  1. Antitumor activity

    Preliminary information on antitumor activity of IPI-145 when combined with rituximab, or bendamustine/rituximab as measured by objective response rate, progression free survival and overall survival data

    Measured: Up to 5 years

Timeline

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

  1. First posted7 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871675
Sponsor's protocol ID
SCRI HEMREF 34
Status last verified
Jul 2016
First submitted
31 May 2013
Last updated
11 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IPI-145, Rituximab and Bendamustine in people with Lymphoma and Chronic Lymphocytic Leukemia, run by SCRI Development Innovations, LLC at 4 sites in United States.

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 24 inclusion and 28 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: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The number of adverse events, serious adverse events, and dose limiting toxicities as a measure of safety and tolerability (time frame: up to 12 months). 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 NCT01871675.

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 11 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in