- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501615
An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia (MOXE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Expanded Access Type
- Individual Patients
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed HCL or HCL variant with a need for therapy based on at least one of the following criteria:
a neutrophils < 1.0x 109/L b platelets < 100 x 109/L c hemoglobin < 10 g/dL d symptomatic splenomegaly
- Pseudomonas-immunotoxin naïve
- At least 2 prior systemic therapies, including 2 courses of a PNA, or 1 course of either rituximab or BRAF inhibitor following a single prior course of PNA.
- Age ≥ 18 years.
- ECOG performance status ≤ 2
Adequate organ function as defined below:
- total bilirubin ≤ 1.5 mg/dL, unless consistent with Gilbert's (ratio between total and direct bilirubin > 5)
- AST and ALT ≤ 3x upper limit of normal (ULN)
- alkaline phosphatase < 2.5 ULN
- serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min as estimated by the Cockcroft-Gault equation
- Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) < 2.5 ULN, fibrinogen ≥ 0.5 lower limit of normal; if on warfarin, INR < 3.5, if on any other anticoagulation, PT < 2.5 x baseline
- Ability to understand and the willingness to sign a written informed consent document.
- Life expectancy ≥ 6 months.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception prior to study entry and for the duration of study participation, and must agree to continue using such precautions for 4 months after completion of moxetumomab pasudotox administration; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
Exclusion Criteria:
1. Have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to initiation of treatment. 2. Receiving any other investigational agents. 3. Known brain metastases 4. Retinal or choroidal detachment identified during the screening ophthalmologic evaluation. 5. Pregnant or breastfeeding females. . 6. Positive for Hepatitis B core antibody or surface antigen unless the patient is on Lamivudine or Entecavir and Hepatitis B Viral deoxyribonucleic acid (DNA) load is < 2000 IU/mL. 7. Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers. 8. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, Symptomatic congestive heart failure, unstable angina pectoris, uncontrolled hypertension, cardiac arrhythmia, malaria infection, or psychiatric illness/social situations that would limit compliance with study requirements. 9. Known human immunodeficiency virus (HIV)-positive patients unless taking appropriate anti-HIV medications with a CD4 count of > 200. 10.History of allogeneic bone marrow transplant. 11.History of both thromboembolism and known congenital hypercoagulable conditions. 12.Uncontrolled pulmonary infection, pulmonary edema 13.Oxygen saturation at rest < 88% measured by pulse oximetry or PaO2
- 55 mm Hg 14.Serum albumin < 2 g/dL 15.Radioimmunotherapy within 2 years prior to enrollment in the study. 16.Absolute neutrophil count (ANC) < 1.0 x 109/L, or platelet count < 50 x 109/L, unless judged by the investigator to be due to underlying disease A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if due to disease, based on the results of bone marrow studies. 17.Patients with < 50% of predicted forced expiratory volume or < 50% of predicted diffusing capacity for carbon monoxide, corrected for hemoglobin concentration and alveolar volume 18.History of thrombotic microangiopathy or thrombotic microangiopathy / HUS. 19.Corrected QT interval (Frederica) elevation > 500 msec (manually over-read by medically qualified person) based on at least two separate 12-lead ECGs. 20.High dose estrogen (defined as > 0.625 mg/day of an estrogen compound). 21.Clinical evidence of disseminated intravascular coagulation (Grade 3- 4).
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nai Shun (Nancy) Yao, MD, MedImmune LLC
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3143R00002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed/Refractory Hairy Cell Leukemia
-
Kite, A Gilead CompanyRecruitingRelapsed/Refractory Waldenstrom Macroglobulinemia | Relapsed/Refractory Richter Transformation | Relapsed/Refractory Burkitt Lymphoma | Relapsed/Refractory Hairy Cell LeukemiaUnited States, Spain, Germany, Italy, France, Netherlands, Switzerland, Austria
-
National Cancer Institute (NCI)Active, not recruitingHairy Cell Leukemia | Recurrent Hairy Cell Leukemia | Hairy Cell Leukemia VariantUnited States
-
Prelude TherapeuticsCompletedAdenoid Cystic Carcinoma | Refractory Chronic Myelomonocytic Leukemia | Relapsed/Refractory Acute Myeloid Leukemia | Relapsed/Refractory Mantle Cell Lymphoma | Relapsed/Refractory Diffuse Large B-cell Lymphoma | Relapsed/Refractory Advanced Solid Tumors | Relapsed/Refractory Myelodysplasia | Relapsed...United States
-
National Cancer Institute (NCI)RecruitingHairy Cell Leukemia | Hairy Cell Leukemia VariantUnited States
-
Memorial Sloan Kettering Cancer CenterYale University; Dana-Farber Cancer InstituteActive, not recruitingLeukemia | Leukemia, Hairy Cell | Hairy Cell LeukemiaUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Northwestern University; Northwell Health; Dana-Farber... and other collaboratorsActive, not recruitingHairy Cell LeukemiaUnited States
-
MedImmune LLCCambridge Antibody TechnologyCompletedHairy Cell LeukemiaUnited States, Poland
-
National Cancer Institute (NCI)TerminatedHairy Cell LeukemiaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHairy Cell Leukemia | Recurrent Hairy Cell LeukemiaUnited States
-
Stanford UniversityAmgen; Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumCompletedRefractory Leukemia | Refractory Solid Tumors | Relapsed Solid Tumors | Relapsed LeukemiaUnited States, Canada
Clinical Trials on Moxetumomab Pasudotox
-
MedImmune LLCCambridge Antibody TechnologyCompletedHairy Cell LeukemiaUnited States, Poland
-
MedImmune LLCCompletedLeukemia, Hairy CellItaly, Spain, United States, Belgium, Poland, Czechia, Germany, Serbia, United Kingdom, France, Israel, Ireland, Canada, Norway
-
MedImmune LLCNational Cancer Institute (NCI)CompletedNon-Hodgkin's Lymphoma | Acute Lymphoblastic LeukemiaUnited States, Canada
-
MedImmune LLCTerminatedB-Cell Pediatric ALLUnited States, Australia, France, Spain, Canada, Netherlands, United Kingdom, Italy
-
M.D. Anderson Cancer CenterMedImmune LLCTerminated
-
Center for International Blood and Marrow Transplant...MedImmune LLC; National Marrow Donor Program; Pediatric Blood and Marrow Transplant... and other collaboratorsTerminatedAcute Lymphoblastic Leukemia (ALL)United States
-
National Cancer Institute (NCI)Active, not recruitingHairy Cell LeukemiaUnited States