A Phase II Study Comparing Romiplostim with Observation for Chemotherapy-Induced Thrombocytopenia

Protocol
13-132
Full Title
A Randomized Open Label Phase II Study of Romiplostim Versus Observation for Chemotherapy Induced Thrombocytopenia
Phase
II
Purpose

Chemotherapy drugs for cancer often reduce the levels of healthy blood cells in the body, such as platelets, which are necessary for blood clotting. When platelet counts fall below a certain level, it is called thrombocytopenia. Patients whose platelet counts fall below 100,000 cannot receive chemotherapy until the count comes back up. Treatment may be delayed or the chemotherapy dose reduced, lowering its effectiveness against the cancer.

In this study, researchers want to see if the drug romiplostim (Nplate) is effective for increasing platelet counts in patients with thrombocytopenia due to chemotherapy. Romiplostim boosts platelet counts and is already approved for treating thrombocytopenia due to other causes.

Researchers will determine if weekly romiplostim injections are more effective for raising platelet counts than waiting for them to rise on their own, and to see if romiplostim enables patients to receive at least two more cycles of chemotherapy without developing thrombocytopenia. Patients will be randomly assigned to receive romiplostim injections, or undergo observation with no treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have thrombocytopenia as a result of chemotherapy for a non-hematologic cancer.
  • At least 2 weeks must have passed since the last dose of chemotherapy and entry into the study.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gerald Soff at 212-639-8108.

Disease(s)
Hematology: Hematologic Disorders
Solid Tumors