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GSK Study ID 104864-201 Adverse Experiences (non-serious) - Adverse Experiences (non-Serious)

- 24.04.18 - 1 Formular, 3 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Identification Numbers, Adverse Experiences (non-Serious), Adverse Experiences (non-Serious)

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

GSK Study ID 104864-201 Response Assessment Study Conclusion - Response Assessment / Study Conclusion

- 24.04.18 - 1 Formular, 6 Itemgruppen, 22 Datenelemente, 1 Sprache

Itemgruppen: Identification Numbers, Response Assessment at the end of the Course, Study Status, Best Overall Response Assessment, Study Conclusion, Investigator`s Signature

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

GSK Study ID 104864-201 Pre-Next Course - Pre-Next Course

- 24.04.18 - 1 Formular, 6 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Identification Numbers, Serious Adverse Experiences, 12-Lead Electrocardiogram, Echocardiogram or Multiple Gated Acquisition Scanning (MUGA), If Yes for the obtained Ejection Fraction, Chest X-Ray

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

GSK Study ID 104864-201 Inclusion-Exclusion Criteria and Telephone Randomisation - Inclusion-Exclusion Criteria and Telephone Randomisation

- 24.04.18 - 1 Formular, 5 Itemgruppen, 32 Datenelemente, 1 Sprache

Itemgruppen: Identification Numbers, Inclusion Criteria, Exclusion Criteria, Telephone Randomisation, If Yes to Telephone Randomisation

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome

Medical History Registry myelodysplastic syndromes and therapy-related AML

- 31.12.17 - 1 Formular, 3 Itemgruppen, 23 Datenelemente, 2 Sprachen

Itemgruppen: Medical history, Toxic agent exposure, Familiy history of hematological malignacies or any other solid cancer

Medical History form REGISTRY OF MYELODYSPLASTIC SYNDROMES AND THERAPY-RELATED ACUTE MYELOID LEUKEMIA OBSERVATOIRE DES SYNDROMES MYELODYSPLASIQUES ET DES LEUCEMIES SECONDAIRES CHIMIO ET RADIO INDUITES DES CENTRES DU G.F.M. Groupe Francophone des Myélodysplasies Pr Pierre FENAUX, Paris

Patient Identification Registry myelodysplastic syndromes and therapy-related AML

- 29.12.17 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 2 Sprachen

Itemgruppe: PATIENT IDENTIFICATION

Patient Identification form REGISTRY OF MYELODYSPLASTIC SYNDROMES AND THERAPY-RELATED ACUTE MYELOID LEUKEMIA OBSERVATOIRE DES SYNDROMES MYELODYSPLASIQUES ET DES LEUCEMIES SECONDAIRES CHIMIO ET RADIO INDUITES DES CENTRES DU G.F.M. Groupe Francophone des Myélodysplasies Pr Pierre FENAUX, Paris

BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Follow up

- 26.11.17 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache

Itemgruppen: Follow up, investigator signature

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Adverse events

- 26.11.17 - 1 Formular, 2 Itemgruppen, 15 Datenelemente, 2 Sprachen

Itemgruppen: Adverse event, investigator signature

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Exclusion because of eligibility determination

- 26.11.17 - 1 Formular, 4 Itemgruppen, 8 Datenelemente, 1 Sprache

Itemgruppen: Eligibility determination, Inclusion Criteria, Exclusion criteria, investigator signature

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Withdrawal from study

- 26.11.17 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Withdrawal from study, investigator signature

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Regular end of Study

- 26.11.17 - 1 Formular, 6 Itemgruppen, 49 Datenelemente, 1 Sprache

Itemgruppen: Regular end of study, Physical examination, Haematology, Differential blood count, Bone marrow examination, investigator signature

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

Sixth cycle of therapy- BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344 - Sixth cycle of therapy

- 26.11.17 - 1 Formular, 10 Itemgruppen, 111 Datenelemente, 1 Sprache

Itemgruppen: Physical examination, Medication: AraC, AraC Protocol, Medication: BIBF 1120, BIBF 1120 protocol, Haematology, Differential blood count, Clinical chemistry, Bone marrow examination, investigator signature

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

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