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Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL

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ClinicalTrials.gov Identifier: NCT04803123
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Dorothy Sipkins, MD, PhD, Duke University

Brief Summary:
This study will provide an evaluation of biologic markers of leukemia cell response following a single dose of copanlisib prior to any salvage induction therapy in a projected cohort of 10 relapsed/refractory B-ALL patients.

Condition or disease Intervention/treatment Phase
Leukemia, Acute Lymphocytic Drug: Copanlisib Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Copanilisib Drug: Copanlisib
Patients must receive at least one dose of copanlisib prior to standard therapy to be evaluable.




Primary Outcome Measures :
  1. Evaluate the effect of copanlisib exposure on alpha-6 integrin expression levels in leukemic blasts using flow cytometry. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. ECOG 0-3.
  3. CrCl ≥ 30 mL/minute.
  4. Bilirubin ≤ 1.5x upper limit of normal (ULN), AST/ALT ≤ 3x ULN.
  5. 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.

Exclusion Criteria:

  1. History of or concurrent condition of interstitial lung disease or autoimmune pneumonitis.
  2. Active pneumonia requiring treatment, including Pneumocystis jirovecci pneumonia (PJP).
  3. History of type 1 diabetes mellitus.
  4. Type 2 diabetes mellitus with HgbA1C ≥10% while on treatment for diabetes.
  5. Uncontrolled hypertension despite optimal medical management (per investigator's assessment).
  6. Untreated human immunodeficiency virus (HIV).
  7. 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.
  8. 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.
  9. History of hematopoietic stem cell transplant with active GVHD requiring > 10 mg of prednisone daily or equivalent.
  10. History of calcineurin inhibitor use in the last 28 days prior to enrollment.
  11. 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.
  12. Pregnancy.
  13. 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.
  14. Active COVID-19 infection.
  15. Progressive and/or uncontrolled infections despite active treatment.
  16. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Dorothy Sipkins, MD 919-613-5010 dorothy.sipkins@duke.edu
Contact: Prioty Islam 919 684 8111 prioty.islam@duke.edu

Locations
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United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Dorothy Sipkins, MD    919-613-5010    dorothy.sipkins@duke.edu   
Sponsors and Collaborators
Dorothy Sipkins, MD, PhD
Bayer
Investigators
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Principal Investigator: Dorothy Sipkins, MD Duke University
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Responsible Party: Dorothy Sipkins, MD, PhD, Associate Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT04803123    
Other Study ID Numbers: Pro00105967
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases