An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia - MOXE

Study identifier:D3143R00002

ClinicalTrials.gov identifier:NCT03501615

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia

Medical condition

Relapsed/refractory hairy cell leukemia

Phase

N/A

Healthy volunteers

Study drug

Moxetumomab Pasudotox

Sex

All

Actual Enrollment

Study type

Expanded Access

Age

N/A

Date

Study Start Date: -

Primary Completion Date: -

Study Completion Date: -

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jun 2020 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1.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
2. Pseudomonas-immunotoxin naïve
3. 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.
4. Age ≥ 18 years.
5. ECOG performance status ≤ 2
6. Adequate organ function as defined below:
a. total bilirubin ≤ 1.5 mg/dL, unless consistent with Gilbert’s (ratio
between total and direct
bilirubin > 5)
b. AST and ALT ≤ 3x upper limit of normal (ULN)
c. alkaline phosphatase < 2.5 ULN
d. serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min
as estimated by the
Cockcroft-Gault equation
7. 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
8. Ability to understand and the willingness to sign a written informed
consent document.
9. Life expectancy ≥ 6 months.
10. 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).
-

No locations available

Arms	Assigned Interventions

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

Clinigen Group

MoxetumomabUSeap@clinigengroup.com

Investigators

Principal Investigator

Nai Shun (Nancy) Yao

MedImmune

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Trial Results Summaries