NCT00004208

Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care

Extracted Fields (from Registry)
Protocol IDNCT00004208
Registration Date2003-01-27
Statuscompleted
SponsorSwiss Cancer Institute
CountrySwitzerland
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2000-08-01
Last Patient Out2011-10-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
Field OPENAI
gpt-4o
Thinking: o3
3090ms / 8468 tok 		GLM
glm-5.1
5930ms / 8647 tok 		CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
4793ms / 9898 tok 		Review
rct_type parallel RCT parallel RCT parallel RCT OK
cancer_status Cancer Cancer Cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient outpatient → mixed → mixed
shaky reasoning
✗ No consensus Initial: outpatient Requery: mixed — The trial involves an outpatient arm for supportive care and an inpatient component for the administration of ATG over 8-12 hours for 5 consecutive days, indicating both inpatient and outpatient settings. Thinking: mixed — The ATG+CSA arm involves multi‐day inpatient infusions, while the control arm is explicitly managed as outpatients, so the trial delivers interventions in both settings.
 mixed mixed → inpatient
shaky reasoning
✗ No consensus Initial: mixed Requery: inpatient — The ATG treatment requires administration over 8-12 hours for 5 consecutive days, which strongly implies that patients are admitted to the hospital during the intervention.
 outpatient outpatient → mixed → outpatient
shaky reasoning
✗ No consensus Initial: outpatient Requery: mixed — The study explicitly includes both inpatient treatment (ATG infusions given over 8-12 hours for 5 consecutive days, which typically requires hospitalization) and outpatient treatment (the supportive care arm is explicitly described as treating patients as outpatients). Thinking: outpatient — While ATG infusion requires 8-12 hours daily for 5 days, the trial does not explicitly state patients are admitted, and Arm B explicitly mentions outpatient treatment.
setting_place hospital other → hospital → hospital
shaky reasoning
✓ Unanimous Initial: other Requery: hospital — The intervention involves administering ATG over 8-12 hours for 5 consecutive days, which likely requires inpatient care in a hospital setting. Thinking: hospital — ATG infusions lasting 8–12 h daily for five days require inpatient administration and monitoring, so the intervention is delivered on a hospital ward.
 hospital hospital
shaky reasoning
✓ Unanimous Initial: hospital
 hospital other → other → hospital
shaky reasoning
✓ Unanimous Initial: other Requery: other — The supportive care arm explicitly states patients will be treated as outpatients, and the overall study design appears to involve outpatient treatment for both arms despite being conducted at a medical center. Thinking: hospital — The ATG + CSA intervention requires intravenous administration over 8-12 hours for 5 consecutive days, which necessitates inpatient hospitalization for treatment delivery.
 OK
feasibility fully powered RCT fully powered RCT fully powered RCT OK
intervention_pharmacologic yes yes yes OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no no OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The trial compares a drug (ATG + CSA) with supportive care setting, not palliative care as an intervention.
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention being tested is a pharmacologic treatment (ATG + CSA immunosuppression), with supportive/palliative care serving only as the control arm, not the experimental intervention itself.
 no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — This is a pharmacologic trial comparing immunosuppressive drugs (ATG + CSA) versus supportive care in MDS patients, not testing palliative care consultation or services as the intervention.
 OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom no no no OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub off label use controlled substances → immunotherapy → off label use
shaky reasoning
✓ Unanimous Initial: controlled substances Requery: immunotherapy — The trial uses antithymocyte globulin (ATG), which is an immunosuppressive agent, indicating the use of immunotherapy. Thinking: off label use — ATG and cyclosporine are FDA-approved immunosuppressive drugs being tested here for the non-approved indication of myelodysplastic syndrome.
 off label use other → other
shaky reasoning
✓ Unanimous Initial: other Requery: other — The pharmacologic intervention uses Antithymocyte Globulin (ATG) and Cyclosporine (CSA), which are immunosuppressive agents used off-label for Myelodysplastic Syndrome, fitting the 'other' category as they are not chemotherapeutic or standard immunotherapies for cancer.
 off label use other → immunotherapy → off label use
shaky reasoning
✓ Unanimous Initial: other Requery: immunotherapy — The trial uses Antithymocyte Globulin (ATG), which is a polyclonal antibody preparation used for immunosuppression, classifying it as immunotherapy. Thinking: off label use — ATG and cyclosporine are FDA-approved immunosuppressive drugs being used for myelodysplastic syndrome, which is not their approved indication.
 OK
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