NCT00542828TerminatedPhase 2
A Phase II Study of the Efficacy of Rabbit Anti-thymocyte Globulin (rATG) in Patients With Low and Intermediate-1 Risk Myelodysplastic Syndrome
Genzyme, a Sanofi Company7 sites in 4 countries16 target enrollmentStarted: October 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 16
- Locations
- 7
- Primary Endpoint
- Number of Participants Who Achieved Hematologic Improvement (HI)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Thymoglobulin
Experimental
Intervention: Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG) (Biological)
Outcomes
Primary Outcomes
Number of Participants Who Achieved Hematologic Improvement (HI)
Time Frame: 12 months
This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a \>=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been \<11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of \>=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.
Secondary Outcomes
- Duration of Disease Remission(36 months)
- Number of Participants With a Marrow Remission(36 months)
- Number of Participants With Duration of HI(36 months)
- Number of Participants Who Achieved Disease Remission(36 months)
- Number of Participants With Transformation to Acute Myeloid Leukemia(36 months)
- Number of Participants With a Cytogenetic Response(36 months)
- Number of Participants Who Achieved Transfusion Independence(36 months)
- Number of Participants With Duration of Transfusion Independence(36 months)
- Number of Participants With a Relapse Following HI(36 months)
- Number of Participants With a Relapse Following Overall Remission(36 months)
- Number of Participants With Progression-free Survival(36 months)
Investigators
Study Sites (7)
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