Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04803123|
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : July 1, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Acute Lymphocytic||Drug: Copanlisib||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||June 21, 2021|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
Patients must receive at least one dose of copanlisib prior to standard therapy to be evaluable.
- Evaluate the effect of copanlisib exposure on alpha-6 integrin expression levels in leukemic blasts using flow cytometry. [ Time Frame: 1 year ]
- Evaluate the effect of copanlisib exposure on proliferation of ALL blasts as determined by flow cytometric blast cell Ki-67 index. [ Time Frame: 1 year ]
- Evaluate the effect of copanlisib exposure on proliferation of ALL blasts as determined by peripheral blood hematologic parameters (CBC and WBC differential including blast percentage). [ Time Frame: 1 year ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Relapsed/refractory, Philadelphia chromosome positive or negative, B-cell, adult (≥ age 18) acute lymphoblastic leukemia (including bone marrow, extramedullary, CNS disease, or all), with or without prior hematopoietic stem cell transplant.
Philadelphia chromosome positive patients prior to enrollment must have documented treatment failure to all FDA-approved for use in R/R ALL tyrosine kinase inhibitor (TKI) therapy, or have previously been deemed by their treating physician to not be a candidate for further TKI therapy.
- ECOG 0-3.
- CrCl ≥ 30 mL/minute.
- Bilirubin ≤ 1.5x upper limit of normal (ULN), AST/ALT ≤ 3x ULN.
- Any patients with known pulmonary disease (including COPD, asthma, ongoing tobacco use, pulmonary hypertension, pulmonary sarcoidosis, or other relevant pulmonary disease which severely limits their pulmonary function), require an assessment of lung capacity with pulmonary function testing prior to acceptance to the study, with a threshold acceptance of DLCO > 40% corrected.
- History of or concurrent condition of interstitial lung disease or autoimmune pneumonitis.
- Active pneumonia requiring treatment, including Pneumocystis jirovecci pneumonia (PJP).
- History of type 1 diabetes mellitus.
- Type 2 diabetes mellitus with HgbA1C ≥10% while on treatment for diabetes.
- Uncontrolled hypertension despite optimal medical management (per investigator's assessment).
- Untreated human immunodeficiency virus (HIV).
- Active replication of hepatitis B or active hepatitis C. Those with prior disease who are PCR negative at enrollment and meet liver function eligibility criterion are eligible.
- Cytomegalovirus (CMV) infection with positive PCR at baseline. CMV PCR test is considered positive if the result can be interpreted as a CMV viremia according to institutional standard.
- History of hematopoietic stem cell transplant with active GVHD requiring > 10 mg of prednisone daily or equivalent.
- History of calcineurin inhibitor use in the last 28 days prior to enrollment.
- Patients requiring immediate cytoreductive therapy. Exceptions for: patients whose peripheral blast counts are being controlled by single agent or combination therapy with steroids and/or hydroxyurea.
- Active concurrent malignancy requiring ongoing treatment. Exceptions for: resected breast cancer being treated with hormonal therapy only, prostate cancer treated with hormonal therapy not progressing within the past year, if subject has received definitive local therapy (i.e., surgical excision, external beam radiation, or other local therapy with curative intent), non-melanoma skin cancers, or carcinoma in situ.
- Active COVID-19 infection.
- Progressive and/or uncontrolled infections despite active treatment.
- Patients with residual toxicities related to prior treatment (including chemotherapy, immunotherapy, clinical trial, surgery, radiotherapy, or hematopoietic stem cell transplant) persistently > Grade 1 despite adequate treatment. Exceptions for: patients with residual toxicity related to prior treatment of ≤Grade 2 which is stable prior to enrollment and for which the natural history would not be expected to change over time; toxicity which cannot be reasonably excluded to be due to disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803123
|Contact: Dorothy Sipkins, MDfirstname.lastname@example.org|
|Contact: Prioty Islam||919 684 email@example.com|
|United States, North Carolina|
|Duke Cancer Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Dorothy Sipkins, MD 919-613-5010 firstname.lastname@example.org|
|Principal Investigator:||Dorothy Sipkins, MD||Duke University|
|Responsible Party:||Dorothy Sipkins, MD, PhD, Associate Professor of Medicine, Duke University|
|Other Study ID Numbers:||
|First Posted:||March 17, 2021 Key Record Dates|
|Last Update Posted:||July 1, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases