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Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndrome (MDS)

Intervention: Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG) (Biological)

Phase: Phase 2

Status: Terminated

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic agents lenalidomide or thalidomide, or who have never been treated for MDS (i. e., treatment-naïve patients).

Clinical Details

Official title: A Phase II Study of the Efficacy of Rabbit Anti-thymocyte Globulin (rATG) in Patients With Low and Intermediate-1 Risk Myelodysplastic Syndrome

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Who Achieved Hematologic Improvement (HI)

Secondary outcome:

Number of Participants With Duration of HI

Number of Participants Who Achieved Disease Remission

Duration of Disease Remission

Number of Participants Who Achieved Transfusion Independence

Number of Participants With Duration of Transfusion Independence

Number of Participants With a Relapse Following HI

Number of Participants With a Relapse Following Overall Remission

Number of Participants With Progression-free Survival

Number of Participants With Transformation to Acute Myeloid Leukemia

Number of Participants With a Cytogenetic Response

Number of Participants With a Marrow Remission

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient provided signed written informed consent.

- Patient had pathologically confirmed low or intermediate-1 risk MDS at the time of

MDS diagnosis and at the time of screening.

- Patient had received no more than 1 prior treatment for MDS.

- Patient exhibited at least 1 hematologic cytopenia (anemia, neutropenia, or

thrombocytopenia) over a period of ≥1 week.

- Patient had documentation of any prior transfusion requirements.

- Patient had an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1,

or 2.

- Patient was ≥18 and ≤70 years of age at time of signing the informed consent document

(ICD).

- Patient was able to adhere to study visit schedule and all other protocol

requirements.

- Patient was willing to practice a medically approved method of birth control during

participation in the study (at least 12 months after the last infusion of rATG) (fertile male and female patients). Exclusion Criteria:

- Patient was pregnant or lactating.

- Patient has had prior treatment with any ATG.

- Patient has received any immunomodulatory or immunosuppressing agents (excluding

steroids) <12 weeks prior to the first infusion of rATG.

- Patient has had a prior hematopoietic stem cell transplantation and/or other organ

transplant.

- Patient has had a prior allergic reaction to rabbit proteins or excipients.

- Patient had any of the following subtypes of MDS: refractory anemia with ringed

sideroblasts (RARS); chronic myelomonocytic leukemia (CMML) if white blood counts >13x10^9/L; or other MDS/myeloproliferative diseases (MPD).

- Patient had MDS associated with a 5q chromosomal deletion unless the patient received

prior lenalidomide treatment <4 weeks prior to the first infusion of rATG.

- Patient had MDS presumed secondary to exposure to chemicals or treatment with

radiotherapy or chemotherapy.

- Patient received any investigational agents within 4 weeks prior to the first

infusion of rATG.

- Patient has any of the following abnormalities: serum creatinine >1. 5 x upper limit

of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) >2. 5 x ULN; or serum total bilirubin >1. 5 x ULN, except for unconjugated hyperbilirubinemia related to the patient's MDS.

- Patient received any treatment with non-steroidal anti-inflammatory drugs (NSAIDs)

within 14 days prior to the start of treatment.

- Patient was known to be human immunodeficiency virus (HIV) positive.

- Patient had any prior diagnosis of malignancy other than MDS, unless the patient had

been disease-free for at least 5 years following the completion of curative intent therapy.

- Patient had any serious medical condition (other than MDS) that would limit survival

to <2 years.

- Patient had active acute or chronic infection, including cytomegaloviremia (CMV)

infection or deep tissue infection.

- Patient had any other serious medical condition, uncontrolled illness (including, but

not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia), social condition, or psychiatric illness that would prevent the patient from signing the informed consent document (ICD), or would place the patient at unacceptable risk if he/she participated in the study, or that would limit compliance with study requirements.

Locations and Contacts

Hopital Avicenne/University, Paris 93009, France

St. Johannes-Hospital Duisburg, Duisburg 47166, Germany

Medizinische Hochschule Hannover, Hannover 30625, Germany

UMC St Radboud Centraal, Nijmegen 6525 GA, Netherlands

Royal Bournemouth Hospital, Bournemouth, England BH7 7DW, United Kingdom

St. James Hospital, Leeds, England LS9 7TF, United Kingdom

King's College Hospital, London, England SE5 9RS, United Kingdom

Additional Information

Starting date: October 2007
Last updated: March 17, 2015

Page last updated: August 20, 2015

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