Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00521664
Other study ID # PEI 1224/01
Secondary ID
Status Completed
Phase Phase 3
First received August 27, 2007
Last updated May 18, 2011
Start date September 2004
Est. completion date September 2010

Study information

Verified date May 2011
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria:

AML project

- inclusion in studies of the DSIL or OSHO group for AML

- AML M3/M3v can be included only when in complete remission

- age 16 - 80 years

- written informed consent

Autologous project

- AMl and ALL patients in first or second remission

- low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma

- conditioning regime: TBI 8-12 Gy/Cy 120 or BEAM or BU/CY or Melphalan 140-200mg/m2 or a similarly intensive chemotherapy regime

- age 16 - 65 years

Exclusion Criteria:

AML project

- known refractoriness to platelet transfusion

- known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing

- known plasmatic coagulation disorder

- patient unable to give informed consent

Autologous project

- known refractoriness to platelet transfusion

- known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing

- known plasmatic coagulation disorder

- patient unable to give informed consent

- patients with pulmonal or cerebral lesions due to infection or neoplasm

- patients with al-amyloidosis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Prophylactic platelet transfusion
In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.
Therapeutic platelet transfusion
In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.

Locations

Country Name City State
Germany Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik Nürnberg

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) 2010 No
Secondary - incidence and duration of clinically relevant bleeding - numbers of red blood cell transfusion - side effects of transfusions - duration of thrombocytopenia below 10.000/µL and below 20.000/µL - duration of hospitalisation 2010 No
See also
  Status Clinical Trial Phase
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Terminated NCT00543972 - Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia Phase 1
Completed NCT05363488 - Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
Completed NCT01380756 - Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia Phase 1
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Terminated NCT00126893 - Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia Phase 1
Completed NCT03613727 - Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients Phase 2
Active, not recruiting NCT04714372 - FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia Phase 1
Recruiting NCT06235801 - A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia Phase 1/Phase 2
Completed NCT02763475 - NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents Phase 2
Terminated NCT01643603 - Dasatinib for Immune Modulation After Donor Stem Cell Transplant for Hematologic Malignancies Phase 1
Completed NCT00497991 - Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia Phase 1
Withdrawn NCT05309018 - Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML
Not yet recruiting NCT05787951 - Frequency and Risk Factors of Acute Myeloid Leukemia
Completed NCT04628338 - IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation Early Phase 1
Completed NCT02719821 - Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation N/A
Active, not recruiting NCT00111345 - Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents Phase 2/Phase 3
Completed NCT00114764 - Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML) Phase 2
Recruiting NCT05871008 - Integrated Actionable Aging Assessment for Cancer Patients Pilot N/A
Recruiting NCT03638206 - Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies Phase 1/Phase 2

External Links