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A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

Protocol: ECOG – EA9181

SCHEMA EA9181

Please Note:  Below is a partial list of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss the full list of eligibility.  Thank you!

Eligibility:

  1. Patient must be ≥ 18 and ≤ 75 years of age.
  2. Patient must have an ECOG performance status between 0-3.
  3. Patient must be newly diagnosed with B-ALL or is suspected to have ALL.
  4. Patient must not have a diagnosis of BCR/ABL T-ALL.
  5. Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of hydroxyurea or steroids of any kind with the aim to reduce disease burden prior to study registration to Step 1 are eligible.
  6. Patients who started any kind of TKI prior to study registration to Step 1 are allowed to proceed on the study if they received no more than 14 days of TKI.
  7. Patients with lymphoid blast crisis CML are not eligible.
  8. Patient must have a diagnosis of Ph+ ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center.
  9. Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible.
  10. Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.

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