A Phase II Study of Efficacy of Rabbit Antithymocyte Globulin (rATG) in patients with Low and Itermediate-1 Risk Mylodysplastic Syndrome - Genzyme ThymoHEMO1206: Phase II study of Thymoglobulin in MDS patients

• Conditions: ow And Intermediate-1 Risk Myelodysplastic Syndrome in adult patients 70 years or younger; MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2007-002532-28-DE
• Lead Sponsor: Genzyme Europe BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1.Provides signed written informed consent.

2.Has pathologically confirmed MDS with a low or intermediate-1 risk score as assessed by IPSS at the time of MDS diagnosis and at time of screening.

3.Has received no more than 1 prior treatment for MDS (excluding steroids, transfusions, antibiotics and other supportive care therapies) and has recovered to = Grade 1 or baseline non-hematological toxicities related to the prior treatment, which is restricted to the following modalities (administered in an investigational or non-investigational setting):

oHematopoietic growth factors, either alone or in combination, 4 weeks prior to the first infusion of rATG.
?For patients for whom erythropoiesis stimulating agents (ESAs) are available therapies for MDS (country specific), the Investigator must determine that the patient either did not respond to a trial of an ESA or did not meet the criteria predictive of an intermediate or high response to ESA. See Appendix D for the erythropoietin (EPO) predictive model.
oAzacitidine, = 4 weeks prior to the first infusion of rATG;
oDecitabine, = 4 weeks prior to the first infusion of rATG;
oLenalidomide, = 4 weeks prior to the first infusion of rATG;
oThalidomide, = 4 weeks prior to the first infusion of rATG

4.Exhibited at least 1 of the following hematologic cytopenias as determined from at least 2 time points over a period of = 1-week.
oAnemia (hemoglobin <11 g/dL)
oNeutropenia (ANC <0.5 x 10*9 /L)
oThrombocytopenia (platelets <20 x10*9 /L).

5.Have documentation of any prior transfusion requirements for the preceding 8 weeks and total duration of any ongoing RBC transfusion dependence.

6.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

7.Be =18 and =70 years of age at the time of signing the informed consent document (ICD). Up to 50% of the patients enrolled in the study may be between the ages of 61 and 70

8.Is able to adhere to study visit schedule and all other protocol requirements,excluding unforeseeable events impacting the visit schedule that do not impact the patient’s safety or the scientific soundness of the data.

9.Is 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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Is pregnant or lactating.

2.Has had prior treatment with any ATG.

3.•Has received any immunomodulatory or immunosuppressing agents (excluding steroids) <12 weeks prior to the first infusion of rATG, with the exception of the MDS treatments allowed in Inclusion Criterion #2

4.Has had a prior HSCT and/or other organ transplant.

5.Has had a prior allergic reaction to rabbit proteins or excipients.

6.Has 1 of the following subtypes of MDS:
•refractory anemia with ringed sideroblasts (RARS), according to WHO classification, or
•chronic myelomonocytic leukemia CMML if WBC count >13 x 10*9 /L, or
•other MDS types of the MDS/myeloproliferative diseases (MPD) group according to WHO classification.

7.Has MDS associated with a 5q chromosomal deletion based upon local bone marrow cytogenetic analysis, unless the patient received prior lenalidomide treatment.

8.Has MDS presumed secondary to exposure to chemicals or treatment with radiotherapy or chemotherapy.

9.Received any investigational agents within 4 weeks prior to the first infusion of rATG, except for the allowable investigational agents outlined in Inclusion Criterion #3.

10.Has a serum creatinine >1.5 x upper limit of normal (ULN).

11.Received any treatment with non-steroidal anti-inflammatory drugs (NSAID) within 14 days prior to start of study treatment.

12.Has aspartate transaminase (AST) and alanine transaminase (ALT) >2.5 x ULN.

13.Has serum total bilirubin >1.5 ULN except for unconjugated hyperbilirubinemia related to the patient’s MDS.

14.Is known to be human immunodeficiency virus (HIV) positive.

15.Has any prior diagnosis of malignancy other than MDS, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions:
•Patients with treated basal-cell skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed,
•Patients with organ-confined prostate cancer, with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values, are also eligible for this study, if hormonal therapy has been initiated or a radical prostatectomy has been performed.

16.Any serious medical condition (other than MDS) that would limit survival to <2 years.

17.Active acute or chronic infection, including active cytomegaloviremia (CMV) infection with positive immunoglobulin M (IgM) titers, and/or CMV-DNA-PCR positive copy numbers, or deep tissue infection.

18.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 will prevent the patient from signing the ICD, or will place the patient at unacceptable risk if he/she participates in the study, or that would limit compliance with study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified