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CASE 4909   |   CC788
A Phase 1 Study of Bortezomib in Combination with MEC (Mitoxantrone, Etoposide, and Intermediate-Dose Cytarabine) for Relapsed/ Refractory Acute Myelogenous Leukemia (AML)

Leukemia, Acute Myeloid (AML)
Main Campus
Phase 1

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Primary Objective

  • To determine the DLT, MTD, and the recommended Phase 2 dose of bortezomib in combination with MEC in patients with relapsed/ refractory AML.

Secondary Objectives

  • To describe the non-dose limiting toxicities associated with bortezomib in combination with MEC in patients with relapsed/refractory AML.
  • To describe any preliminary evidence of clinical activity of this combination (CR rate) in relapsed/refractory AML.
  • To determine the median CD74 antigen expression in patients achieving a response versus those patients not achieving a response.

Inclusion Criteria
  1. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  2. Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception (ie., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse. Female subject is not lactating.
  3. Male subject, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
  4. Subjects with a prior diagnosis of AML (excluding acute promyelocytic leukemia) based on World Health Organization Classification who did not achieve Complete Response (CR) with their previous therapy or who have relapsed after achieving a Complete Response (CR) are eligible. Any number of relapses will be eligible. Patients must have >5% blasts in the bone marrow at the time of study enrollment.
  5. Age ≥ 18 and ≤ 70 years (Seventy years was chosen as a cut-off since the backbone regimen MEC is not well tolerated in patients > 70 years of age).
  6. No evidence of leptomeningeal disease. A lumbar puncture does not need to be performed unless there is clinical suspicion of leptomeningeal disease.
  7. Previous treatment related toxicities must have resolved to Grade 1 (excluding alopecia).
  8. Liver enzymes (AST and ALT) can not be greater than 2.5 times the upper limits of normal (ULN), and total bilirubin ≤ 1.5 x ULN within 14 days of enrollment.
  9. Renal function: Serum creatinine should be ≤ 1.5 x ULN within 14 days of enrollment.
  10. No serious or poorly controlled medical conditions that could be exacerbated by treatment or that would seriously complicate compliance with the protocol.
  11. ECOG performance status 0-3.
  12. No peripheral neuropathy ≥ Grade 2 within 14 days of trial enrollment.
  13. Echocardiogram or MUGAs scan demonstrating an ejection fraction ≥ 45%.
  14. Patients with secondary AML, and patients with a prior autologous and allogeneic bone marrow transplant are eligible.
  15. Patients with an allogeneic transplant must meet the following conditions: the transplant must have been performed more than 90 days before registration to this study, the patient must not have ≥ Grade 2 acute graft versus host disease (GvHD), or either moderate or severe limited chronic GvHD, or extensive chronic GvHD of any severity. The patient must be off all immunosuppression for at least 2 weeks.
  16. No uncontrolled infections.
  17. No history of hypersensitivity to boron or mannitol.
  18. No known history of HIV or active hepatitis B or C.
  19. No major surgery within 4 weeks prior to trial enrollment.

Exclusion Criteria
  1. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  2. Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
  3. Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  4. Patient has received any standard or investigational therapy for their leukemia within 14 days before enrollment (except for hydrea).
  5. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  6. Patients with prior malignancy are eligible. However, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment related toxicities must have resolved.
  7. Leptomeningeal/ central nervous system involvement with AML. A lumbar puncture does not need to be performed unless there is clinical suspicion.
  8. Patients who have had prior pulmonary radiation.

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