Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

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Brief Title

Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Official Title

a Phase i/Iia, Open Label, Uncontrolled Study to Evaluate the Safety and Efficacy of Astarabine (BST-236) as Single Agent in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) Disease

Brief Summary

      A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of
      Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid
      Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease
    

Detailed Description

      This is prospective, Phase I/IIa, open-label, uncontrolled, single-center, single arm study
      to evaluate the safety and efficacy of Astarabine given intravenously (I.V.) in escalated
      doses for 6 days for cycle in patients with relapsed or refractory AML or ALL who are more
      than 18 years of age. Patients will be screened for eligibility based on existing records
      and/or specific laboratory examinations performed for the screening process.

      Patients will be gradually enrolled into 4 subsequent cohorts of escalating drug doses:

      Cohort # Astarabine Dose Number of Patients

        1. 0.5 gr/m2 (0.3 age>50) 3

        2. 1.5 gr/m2 (0.8age>50) 3

        3. 3.0 gr/m2 (1.5 age>50) 3

        4. 4.5 gr/m2 (2.3 age>50) 6

        5. 4.5 gr/m2 (no age limit) 3 up to 6

        6. 6 gr/m2 (no age limit) 3 up to 6

      Maximal tolerated dose (MTD) will be defined in case 2 subjects will experience a dose
      limiting toxicity (DLT)
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximal tolerated dose (MTD)

Secondary Outcome

 safety and tolerability expressed by any grade adverse events (AEs)

Condition

Acute Myeloid Leukemia

Intervention

Astarabine (BST-236)

Study Arms / Comparison Groups

 Astarabine
Description:  Astarabine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

September 2015

Completion Date

September 20, 2017

Primary Completion Date

September 20, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. A. Relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia
             (ALL), based on World Health Organization Classification; Patients must have
             morphological proof of AML or ALL with blasts in peripheral blood (PB) or 5% in bone
             marrow (BM) within 2 weeks prior to study registration.

             I. Refractory disease will be considered failure to either respond to induction
             chemotherapy and/or salvage therapy.

             II. 2nd relapse III. Relapse following autologous or allogeneic stem cell
             transplantation. B. patients which at the physician discretion are not eligible for
             standard chemotherapy, whether induction or consolidation, due to age or significant
             co-morbidities

          2. Age ≥18 years.

          3. Ability to understand and willingness to sign the written informed consent document.

          4. Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment and use adequate contraception (hormonal or barrier
             method of birth control; abstinence) prior to study entry and for the duration of
             study participation. Should woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately.

          5. Male subject agrees to use an acceptable method for contraception for the duration of
             the study.

          6. Eastern cooperative oncology group (ECOG) performance status ≤ 2

          7. Hydroxyurea is permitted to control high white blood cells (WBC) count prior to study
             entry.

          8. Previous treatment related toxicities must have resolved to less than Grade 2
             (excluding alopecia).

        Exclusion Criteria:

          1. Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, serious
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements. l. Myocardial infarction within 6 months prior to
             enrollment or has New York Heart Association (NYHA) Class III or IV heart failure,
             uncontrolled angina, uncontrolled hypertension, severe uncontrolled ventricular
             arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction
             system abnormalities. Prior to study entry, any ECG abnormality at screening has to be
             documented by the investigator as not medically relevant.

          2. Patients with compromised pulmonary function who needs oxygen therapy.

          3. Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results.

          4. Patients who have had chemotherapy (except for hydroxyurea), biologic therapy,
             immunotherapy, or radiotherapy within 2 weeks of induction therapy or 4 weeks of
             consolidation or intensive therapy (6 weeks for nitrosoureas or mitomycin C) prior to
             entering the study or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier.

          5. Patients receiving any other investigational agents.

          6. Patients who have had any surgical procedure, excluding central venous catheter
             placement or other minor procedures (e.g. skin biopsy) within 14 days of Day 1.

          7. Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          8. Patients with prior malignancy are eligible; however, the patient must be in remission
             from the prior malignancy and have completed all chemotherapy and radiotherapy at
             least 6 months prior to registration and all treatment-related toxicities must have
             resolved.

          9. Leptomeningeal/ central nervous system involvement with AML; a lumbar puncture does
             not need to be performed unless there is clinical suspicion.

         10. Patients with active central nervous system disease or with granulocytic sarcoma as
             sole site of disease.

         11. Patients who have had prior pulmonary radiation.

         12. Liver enzymes (AST and alanine aminotransferase (ALT) more than 2.5 times the upper
             limits of normal (ULN), and total bilirubin more than 1.5 x ULN within 14 days of
             enrollment.

         13. Renal function: Serum creatinine more than 1.5 x ULN within 24 hours of enrollment.

         14. Existence of inter-current organ damage or medical condition that would prohibit or
             interfere with study drug therapy.

         15. If the patient has co-morbid medical illness, life expectancy attributed to this must
             be greater than 3 months.

         16. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Astarabine/Ara-C.

         17. Pregnant women are excluded from this study because Astarabine/Ara-C are agents with
             the potential for teratogenic or abortifacient effects. Because there is an unknown
             but potential risk for adverse events in nursing infants secondary to treatment of the
             mother with Astarabine, breastfeeding should be discontinued if the mother is treated
             with Astarabine.

         18. known history of Human immunodeficiency virus (HIV) or active hepatitis B or C

         19. Concurrent use of the following medications: Digoxin, Gentamycin, fluorocytosine,
             L-asparginase, any drugs or supplements that interfere with blood clotting can raise
             the risk of bleeding during treatment with Ara-C. These include: vitamin E,
             non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, warfarin, ticlopidine,
             clopidogrel.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tsila Zuckerman, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02544438

Organization ID

BST-PHASE1-01


Responsible Party

Sponsor

Study Sponsor

BioSight Ltd.


Study Sponsor

Tsila Zuckerman, MD, Principal Investigator, Rambam Health Care Campus


Verification Date

September 2017