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Leukemia and Myeloproliferative Disorders

Acute Lymphocytic Leukemia (ALL)

1

Disease Status and/or Stage Refractory or Relapsed AML, ALL, or MDS
Protocol Title Phase I Study of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Patients with Advanced Hematologic Malignancies
PI Eric Feldman, MD
Contact Tania Curcio, RN
212-746-2571
Key Eligibility AML patients in 2nd or greater relapse OR in 1st relapse with initial CR lasting less than 6 months OR primiry refractory following 2 cycles of induction.

ALL (relapsed/refractory) patients or refractory T-ALL following nelarabine.

MDS with >10% blasts with at least 1 prior therapy that includes a hypomethylating agent
Treatment Overview The study drug, CPX-351 is administered intravenously over 90 minutes on days 1, 3, and 5 of the study. If no adverse events occur, dosing will repeat after day 14.

Patients can continue on study for up to 100 days as long as they are benefiting from the study drug and there are no intolerable side effects.

2

Disease Status and/or Stage Ph+ CML or Ph+ ALL
Protocol Title A Phase I/II Study of SKI-606 in Philadelphia Chromosome Positive Leukemias
PI Richard Silver, MD
Contact Tania Curcio, RN
212-746-2571
Key Eligibility Adults at least 18 years old whose disease is resistant to full-dose Imatinib or intolerant to any dose of Imatinib.
Treatment Overview

500 mg daily capsules of study drug (SKI-606)

Clinic visits for monitroing will occur weekly for the first 4 weeks, at weeks 8 and 12, and every 12 weeks thereafter.

Participation may last up to 52 weeks or until discontinuation of study drug.

3

Disease Status and/or Stage Any Stage of Cancer
Protocol Title Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis
Treatment Overview

All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)
 
Last updated: July 30, 2008
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