Prolymphocytic LeukemiaPhase 2NCT02285244
Sotrastaurin Acetate in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Prolymphocytic Leukemia, or Richter's Transformation
A Phase 2 study testing sotrastaurin acetate, pharmacological study and laboratory biomarker analysis in people with Prolymphocytic Leukemia and Recurrent Mantle Cell Lymphoma, run by James Blachly.
Trial summary
This phase II trial studies how well sotrastaurin acetate works in treating patients with chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or Richter's transformation that has returned or that does not respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolymphocytic Leukemia, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma
- What is being tested?
- sotrastaurin acetate, pharmacological study and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2015to 12 Mar 2015
- Phase
- Phase 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
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Life expectancy >= 2 months
- Appropriate histologic diagnosis (a) or (b):
- (a) Histologically documented diagnosis of intermediate or high risk CLL/SLL, B-PLL, and RT arising from CLL/SLL according to the 2008 guidelines, meeting criteria for active disease requiring treatment:
- Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
- Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
Show all 18Show fewer
- Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy
- Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
- Constitutional symptoms including any of the following:
- Unintentional weight loss of 10% or more within 6 mos.
- Significant fatigue limiting activity
- Fevers >= 100.5 degrees F for 2 weeks or more without evidence of infection
- Night sweats > 1 month without evidence of infection
- Need for cytoreduction prior to stem cell transplantation
- (b) Pathologically documented MCL [defined as either t(11;14) or overexpression of cyclin D1] for the MCL pilot study
- Relapsed after or refractory to at least one prior therapy
- Willingness to undergo all study-related evaluations and procedures
- Ability to understand and willingness to execute a written informed consent document
Who cannot join
- Prior therapy as follows:
- Major surgery within 2 weeks
- Corticosteroids greater than 20 mg/day prednisone (or equivalent) within 2 weeks unless used by inhalation or topical route, or unless necessary for premedication before iodinated contrast dye, or for autoimmune hemolytic anemia
- Cytotoxic chemotherapy or biologic therapy within 4 weeks, excepting BCR kinase inhibitors for which no wash out is required, or
- Nitrosoureas within the 6 weeks of the planned first dose of the study drug
- Failure to recover toxicity from prior chemo- or radiotherapy to grade 1
Show all 32Show fewer
- Known active leukemia or lymphoma of the central nervous system (CNS) requiring therapy
- Inadequate bone marrow function/hematopoietic reserve, except in the case of documented bone-marrow involvement: absolute neutrophil count (ANC) < 1 x 10^9/L
- Inadequate bone marrow function/hematopoietic reserve, except in the case of documented bone-marrow involvement: platelets < 30 x 10^9/L
- Serum total bilirubin > 2 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN, or > 5 x ULN if CLL/lymphoma is present in the liver
- Estimated glomerular filtration rate (GFR) < 30 mL/min
- Patients who are receiving treatment with medications that are known to be strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) and CYP3A4/5 substrates with QT prolongation risk that cannot be discontinued prior to study entry
- Clinically significant cardiac diseases, including any of the following:
- History or presence of ventricular tachyarrhythmia
- Presence of unstable/uncontrolled atrial fibrillation (with ventricular rate > 100 beats per minute [bpm]); patients with stable atrial fibrillation are eligible provided that they do not meet any of the other exclusion criteria
- Angina pectoris or acute myocardial infarction within 3 months of starting study drug
- New York Heart Association (NYHA) functional class III or IV heart failure
- Labile or uncontrolled hypertension
- History of another malignancy that limits survival to less than 2 years in the estimate of the investigator; basal and squamous cell cancers of the skin, or squamous cell carcinoma of the cervix in situ, which were completely resected or otherwise cured, or localized prostate cancer (Gleason < 5) are eligible
- Gastrointestinal dysfunction, including motility or malabsorption syndromes or inflammatory bowel disease which could limit absorption of AEB071
- Known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection with detectible viral nucleic acid in the blood; testing for these viruses is not a required part of screening
- Severe systemic infections requiring intravenous antibiotics within the two weeks prior to initiation of AEB071
- Lactating or pregnant
- Women of child-bearing potential or male partners of women of child-bearing potential who will not agree to use highly effective method of contraception throughout the entire study period and for a minimum of 5 terminal half-lives of AEB071 (approximately 36 hours) after the last dose of study drug; highly effective contraception methods include:
- Total abstinence or
- Male or female sterilization or
- Combination of any two of the following (a+b or a+c or b+c):
- a. Use of oral, injected or implanted hormonal methods of contraception
- b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
- Any other life-threatening illness or medical condition that, in the opinion of the investigator, could compromise the safety of the patient or interfere with analysis of study endpoints
About this study
Official title: A Phase 2 Feasibility Study of Sotrastaurin for Relapsed and Refractory CLL/SLL/PLL/RT
This phase II trial studies how well sotrastaurin acetate works in treating patients with chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or Richter's transformation that has returned or that does not respond to treatment. Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the objective clinical response rate of AEB071 (sotrastaurin acetate) treatment in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL)/Richter's transformation (RT).
SECONDARY OBJECTIVES:
- To determine the feasibility and tolerability of long-term administration of a fixed dose of AEB071 in patients with relapsed or refractory CLL/SLL/PLL.
II. To examine select downstream pharmacodynamic effects in this population of patients after receiving AEB071 including assessment of the wingless-type MMTV integration site family (WNT) signaling pathway.
III. To determine the feasibility and tolerability of AEB071 treatment in patients with relapsed or refractory mantle cell lymphoma (MCL) as well as to gain preliminary data regarding efficacy in this patient population.
TERTIARY OBJECTIVES:
- Determine the proportion of patients with select germline and somatic deoxyribonucleic acid (DNA) alterations, including in the B-cell receptor (BCR) pathway.
II. Determine how mutational and transcriptional status in key genes affects response to this therapy and may have affected response to prior therapies.
OUTLINE:
Patients receive sotrastaurin acetate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then at least every 3 months thereafter.
- Conditions
- Prolymphocytic Leukemia, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Richter Syndrome
- Being tested
- sotrastaurin acetate, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Leukemia, Prolymphocytic, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sotrastaurin acetateDrug
Also called AEB 071, AEB071
Given PO
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (sotrastaurin acetate) | Experimental | Patients receive sotrastaurin acetate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: sotrastaurin acetate; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of CLL/SLL/PLL/RT patients who achieve an objective clinical response, estimated by the number of complete, partial, or partial responses with lymphocytosis divided by the total number of evaluable patients
Categories of response for CLL and PLL patients defined according to criteria published by the International Workshop on CLL. Response for SLL/RT patients will be according to revised response criteria for malignant lymphoma. The objective response rate for all evaluable patients in the phase II study will be calculated with an exact 95% binomial confidence interval (assuming that the number of patients who respond is binomially distributed).
Measured: Up to 9 months
Secondary outcomes (18)
Response duration
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: From the time at which criteria for CR, PR, or PR with lymphocytosis is first assessed until the date at which recurrent or progressive disease or death due to disease is documented, assessed up to 3 years
Progression free survival (PFS)
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Time from the first dose of the study drug until disease progression or death from any cause, assessed up to 3 years
Overall survival (OS)
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Time from the first dose of the study drug until death, assessed up to 3 years
Rate of objective clinical response (CR, PR) (optional PLCG2 enriched cohort, if activated)
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Up to 3 years
Response duration (optional PLCG2 enriched cohort, if activated)
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: From the time at which criteria for CR, PR, or PR with lymphocytosis is first assessed until the date at which recurrent or progressive disease or death due to disease is documented, assessed up to 3 years
PFS (optional PLCG2 enriched cohort, if activated)
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Time from the first dose of the study drug until disease progression or death from any cause, assessed up to 3 years
OS (optional PLCG2 enriched cohort, if activated)
For CLL and PLL patients, defined according to the criteria published by the International Workshop on CLL with the modification outlined by Cheson et al. For SLL/RT patients, responses will be according to revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Time from the first dose of the study drug until death, assessed up to 3 years
Rate of objective clinical response (CR, PR) (MCL cohort)
Responses are defined according the revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Up to 3 years
Response duration (MCL cohort)
Responses are defined according the revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: From the time at which criteria for CR, PR, or PR with lymphocytosis is first assessed until the date at which recurrent or progressive disease or death due to disease is documented, assessed up to 3 years
PFS (MCL cohort)
Responses are defined according the revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Time from the first dose of the study drug until disease progression or death from any cause, assessed up to 3 years
OS (MCL cohort)
Responses are defined according the revised response criteria for malignant lymphoma. Summarized using standard Kaplan-Meier methods.
Measured: Time from the first dose of the study drug until death, assessed up to 3 years
Incidence of adverse events (AEs), assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria
For each disease group, frequency and severity of adverse events will be collected and summarized by descriptive statistics.
Measured: Up to 30 days post-treatment
Frequency of AEs requiring dose reduction or drug discontinuation
Number of patients who require dose modifications and/or dose delays will be assessed.
Measured: Up to 30 days post-treatment
Number of courses completed
Number of courses started/completed and the reasons for going off-treatment will be assessed.
Measured: Up to 30 days post-treatment
Pharmacodynamic modulation of the downstream targets of the BCR (including LCP1) after sotrastaurin acetate treatment
Markers will be summarized univariately in a quantitative manner and also summarized by clinical outcome group graphically to assess potential patterns and relationships. Changes in BCR signaling over time may be evaluated quantitatively using repeated measures models and graphically with individual time plots or box plots.
Measured: Baseline to up to course 1 day 29
Pharmacodynamic modulation of the downstream targets of nuclear transcription factor kappa-B after sotrastaurin acetate treatment
Markers will be summarized univariately in a quantitative manner and also summarized by clinical outcome group graphically to assess potential patterns and relationships.
Measured: Baseline to up to course 1 day 29
Pharmacodynamic modulation of downstream targets of WNT/beta-catenin pathway
Markers will be summarized univariately in a quantitative manner and also summarized by clinical outcome group graphically to assess potential patterns and relationships.
Measured: Baseline to up to course 1 day 29
Genomic features associated with response by deep sequencing panel targeted at recurrent mutations in CLL
Markers will be summarized univariately in a quantitative manner and also summarized by clinical outcome group graphically to assess potential patterns and relationships.
Measured: Up to course 1 day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start12 Mar 2015
- Primary completion12 Mar 2015
- Study completion12 Mar 2015
Why it stopped: Decision made by the Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Blachly
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, James Blachly, Ohio State University Comprehensive Cancer Center
- Investigators
- James Blachly, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285244
- Sponsor's protocol ID
- OSU-14026
- Other IDs
- NCI-2014-02002, COEB071XUS01T
- Status last verified
- Apr 2017
- First submitted
- 4 Nov 2014
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Feasibility Study of Sotrastaurin for Relapsed and Refractory CLL/SLL/PLL/RT
- ClinicalTrials.gov ID
- NCT02285244
- Acronym / sponsor ID
- OSU-14026
- Conditions
- Prolymphocytic Leukemia, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Richter Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision made by the Principal Investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- James BlachlyUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 12 Mar 2015 (actual)
- Study completion
- 12 Mar 2015 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well sotrastaurin acetate works in treating patients with chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or Richter's transformation that has returned or that does not respond to treatment. Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To determine the objective clinical response rate of AEB071 (sotrastaurin acetate) treatment in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL)/Richter's transformation (RT).
SECONDARY OBJECTIVES:
- To determine the feasibility and tolerability of long-term administration of a fixed dose of AEB071 in patients with relapsed or refractory CLL/SLL/PLL.
II. To examine select downstream pharmacodynamic effects in this population of patients after receiving AEB071 including assessment of the wingless-type MMTV integration site family (WNT) signaling pathway.
III. To determine the feasibility and tolerability of AEB071 treatment in patients with relapsed or refractory mantle cell lymphoma (MCL) as well as to gain preliminary data regarding efficacy in this patient population.
TERTIARY OBJECTIVES:
- Determine the proportion of patients with select germline and somatic deoxyribonucleic acid (DNA) alterations, including in the B-cell receptor (BCR) pathway.
II. Determine how mutational and transcriptional status in key genes affects response to this therapy and may have affected response to prior therapies.
OUTLINE:
Patients receive sotrastaurin acetate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then at least every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (sotrastaurin acetate) | Experimental | Drug: sotrastaurin acetate, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive sotrastaurin acetate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Life expectancy >= 2 months
- Appropriate histologic diagnosis (a) or (b):
- Relapsed after or refractory to at least one prior therapy
- Willingness to undergo all study-related evaluations and procedures
Key exclusion criteria (32 listed)
- Prior therapy as follows:
- Failure to recover toxicity from prior chemo- or radiotherapy to grade 1
- Known active leukemia or lymphoma of the central nervous system (CNS) requiring therapy
- Inadequate bone marrow function/hematopoietic reserve, except in the case of documented bone-marrow involvement: absolute neutrophil count (ANC) < 1 x 10^9/L
- Inadequate bone marrow function/hematopoietic reserve, except in the case of documented bone-marrow involvement: platelets < 30 x 10^9/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sotrastaurin acetateAlso: AEB 071, AEB071Given PO | Drug | Treatment (sotrastaurin acetate) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (sotrastaurin acetate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (sotrastaurin acetate) |
Primary outcome
Proportion of CLL/SLL/PLL/RT patients who achieve an objective clinical response, estimated by the number of complete, partial, or partial responses with lymphocytosis divided by the total number of evaluable patients
Time frame: Up to 9 months
Categories of response for CLL and PLL patients defined according to criteria published by the International Workshop on CLL. Response for SLL/RT patients will be according to revised response criteria for malignant lymphoma. The objective response rate for all evaluable patients in the phase II study will be calculated with an exact 95% binomial confidence interval (assuming that the number of patients who respond is binomially distributed).
18 secondary outcomes
Response duration
Time frame: From the time at which criteria for CR, PR, or PR with lymphocytosis is first assessed until the date at which recurrent or progressive disease or death due to disease is documented, assessed up to 3 years
Progression free survival (PFS)
Time frame: Time from the first dose of the study drug until disease progression or death from any cause, assessed up to 3 years
Overall survival (OS)
Time frame: Time from the first dose of the study drug until death, assessed up to 3 years
Rate of objective clinical response (CR, PR) (optional PLCG2 enriched cohort, if activated)
Time frame: Up to 3 years
Response duration (optional PLCG2 enriched cohort, if activated)
Time frame: From the time at which criteria for CR, PR, or PR with lymphocytosis is first assessed until the date at which recurrent or progressive disease or death due to disease is documented, assessed up to 3 years
PFS (optional PLCG2 enriched cohort, if activated)
Time frame: Time from the first dose of the study drug until disease progression or death from any cause, assessed up to 3 years
OS (optional PLCG2 enriched cohort, if activated)
Time frame: Time from the first dose of the study drug until death, assessed up to 3 years
Rate of objective clinical response (CR, PR) (MCL cohort)
Time frame: Up to 3 years
Response duration (MCL cohort)
Time frame: From the time at which criteria for CR, PR, or PR with lymphocytosis is first assessed until the date at which recurrent or progressive disease or death due to disease is documented, assessed up to 3 years
PFS (MCL cohort)
Time frame: Time from the first dose of the study drug until disease progression or death from any cause, assessed up to 3 years
OS (MCL cohort)
Time frame: Time from the first dose of the study drug until death, assessed up to 3 years
Incidence of adverse events (AEs), assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria
Time frame: Up to 30 days post-treatment
Frequency of AEs requiring dose reduction or drug discontinuation
Time frame: Up to 30 days post-treatment
Number of courses completed
Time frame: Up to 30 days post-treatment
Pharmacodynamic modulation of the downstream targets of the BCR (including LCP1) after sotrastaurin acetate treatment
Time frame: Baseline to up to course 1 day 29
Pharmacodynamic modulation of the downstream targets of nuclear transcription factor kappa-B after sotrastaurin acetate treatment
Time frame: Baseline to up to course 1 day 29
Pharmacodynamic modulation of downstream targets of WNT/beta-catenin pathway
Time frame: Baseline to up to course 1 day 29
Genomic features associated with response by deep sequencing panel targeted at recurrent mutations in CLL
Time frame: Up to course 1 day 29
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Blachly, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sotrastaurin acetate, pharmacological study and laboratory biomarker analysis in people with Prolymphocytic Leukemia and Recurrent Mantle Cell Lymphoma, run by James Blachly.
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 18 inclusion and 32 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: withdrawn, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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 withdrawn before enrolling participants, so there are no results.
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?
Proportion of CLL/SLL/PLL/RT patients who achieve an objective clinical response, estimated by the number of complete, partial, or partial responses with lymphocytosis divided by the total number of evaluable patients (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2017.