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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00074763 |
Purpose
Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Procedure: Platelet Transfusion |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets |
| Enrollment: | 4 |
| Study Start Date: | November 2003 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Platelet Transfusion
ThromboSol-preserved autologous platelet transfusion or Standard platelet transfusion
|
Procedure: Platelet Transfusion
All receive both platelets frozen with Thrombosol and fresh random platelets (FRP), order received is randomized, i.e. receive either FRP then Thrombosol or Thrombosol then FRP.
|
Platelets are an important component of blood. Transfusions with platelets help to control bleeding in thrombocytopenic patients. Using the standard blood banking procedures, platelets can only be stored for up to 5 days. This is to help decrease the risk of contamination with bacteria. Currently, it is not possible to use cryopreserved (frozen) platelets because the platelets are damaged during the freezing process. Therefore, long-term banking of platelets or autologous donation (storing your own platelets to be given back to you at a later time) has not been possible. ThromboSol is a new solution that was designed to allow platelets to be frozen without damaging them. The use of ThromboSol may allow for long-term banking of platelets and/or autologous donations.
During a period of cancer remission and when you have enough platelets in your blood, you will undergo an apheresis procedure to collect platelets. This procedure is similar to donating plasma to a blood bank. You will have up to 6 apheresis procedures (on different days) to collect up to 6 units of autologous platelets that can be transfused back to you. The platelets that are collected will be frozen with ThromboSol and stored so that they may be given back to you if your platelet count drops below a certain level. The frozen platelets can be stored for up to 18 months.
When your platelet count drops below a certain level, you will be scheduled to have a platelet transfusion as part of your standard care.
Before the transfusion you will have blood drawn (around 1-2 teaspoons) to check on the number of platelets in your blood. You will then be randomly assigned (as in the toss of a coin) to either receive the standard platelet transfusion or a ThromboSol-preserved autologous platelet transfusion. After the transfusion, you will have additional blood drawn (around 1-2 teaspoons) to check on the number of platelets in your blood. These procedures will be repeated each time you require a platelet transfusion. However, you will not be randomly assigned again. Each time you receive an additional platelet transfusion, you will be assigned the group different from the one before. The type of transfusions will be alternated. For instance, if you were randomly assigned to receive the frozen platelets for your first transfusion, you will receive the standard transfusion next, then back to the frozen for the third transfusion.
If you develop side effects to the ThromboSol-preserved autologous platelet transfusion or the number of platelets in your blood does not increase after an infusion with the preserved platelets, you will be taken off the study and given a standard platelet transfusion.
This is an investigational study. Up to 54 participants will take part in this study. All will be enrolled at UTMDACC.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1) 1.- Patients in remission with ALL, CLL, AML, CML, MDS will be allowed to participate in this program if their platelet count is >150K, and the hemoglobin level is at least 8.0g/dl. The patient will receive their autologous platelets cryopreserved in ThromboSol or the fresh random platelets (FRP) whenever the need for such transfusions is determined to be clinically indicated by their physician(s).
Exclusion Criteria:
1) Patients with detectable circulating malignant cells or ongoing marrow involvement by the tumor will not be eligible.
Contacts and Locations| United States, Texas | |
| UT M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Benjamin Lichtiger, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Benjamin Lichtiger, MD, PhD, BS, BA, MBA / Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00074763 History of Changes |
| Other Study ID Numbers: | ID03-0088 |
| Study First Received: | December 19, 2003 |
| Last Updated: | October 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia Lymphoma ALL CLL AML CML MDS Remission |
Hematologic Disorder Transfusion Thrombosol Autologous Platelet Transfusion Platelet Transfusion Single donor platelet apheresis Cryopreservation Thrombocytopenia |
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
