Leukemia and Myeloproliferative Disorders
Acute Myeloid Leukemia (AML)
1
| Disease Status and/or Stage | Newly Diagnosed |
|---|---|
| Protocol Title | An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination with Arsenic Trioxide Compared with Low-Dose Cytarabine Alone for the Treatment of Elderly Patients with Acute Myeloid Leukemia |
| PI | Gail J. Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Adults at least 60 years of age, who are unwilling or unable to tolerate conventional induction chemotherapy, are eligible. The patient must NOT have had previous cytotoxic chemotherapy for AML or myelodysplastic syndrome (MDS). |
| Treatment Overview | Patients will be randomized to receive either cytarabine alone or arsenic trioxide in combination with cytarabine. Arsenic trioxide will be administered intravenously (IV) at a dose of 0.25 mg/kg and cytarabine will be administered at a dose of 10 mg/m2 subcutaneously. Patients may be on-study for up to 2 years. |
2
| Disease Status and/or Stage | CD33 positive AML, MDS, CMMoL or other myeloproliferative syndrome |
|---|---|
| Protocol Title | A Phase I, Multi-Dose Study of SGN-33 (anti-huCD33 mAb; HuM195; lintuzumab) in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome |
| PI | Gail Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients must have a diagnosis of MDS, AML, CMMoL, or other myeloproliferative syndrome with confirmation by flow cytometry of CD33 expression on the malignant cells. |
| Treatment Overview | This is a multi-dose study. Patients will receive different doses of the study drug depending upon when they join the study. SGN-33 will be administered by IV infusion on Days 1, 2, 8, 15, 22, and 29. Treatment will last approximately 5 weeks. Patients who respond to the study drug may receive 4 additional infusions every other week. |
3
| 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. |
4
| Disease Status and/or Stage | Acute Myeloid Leukemia in second or subsequent remission or in remission after primary induction |
|---|---|
| Protocol Title | E2902: A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML). Patients in Second or Subsequent Remission or in Remission after Primary Induction Failure or Patients over Age 60 in First Remission |
| PI | Eric Feldman, MD |
| Contact | Sandy Allen-Bard, RN 212-746-2134 |
| Key Eligibility | Patients must be in first remission following primary induction failure (patients must have received at least two chemotherapy induction regimens), be in second or subsequent remission, or patients >60 years old in first remission. Patients must be in CR or MP (molecular remission) by blood counts and bone marrow studies. Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) that they had AML. |
| Treatment Overview | Patients will be randomized to receive R115777 (Arm A) or not receive R115777 (Arm B - Observation) |
5
| Disease Status and/or Stage | Newly diagnosed OR previously treated. Subgroup associated with less-than-favorable risk. |
|---|---|
| Protocol Title | Phase I Study of Epigenetic Priming Using Decitabine with Induction Chemotherapy in Acute Myelogenous Leukemia. |
| PI | Joseph Scandura, M.D., Ph.D. |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Adults between 18 and 60 years old who meet criteria for less-than-favorable risk. Patients must have adequate cardiac and hepatic/renal function. |
| Treatment Overview | Subjects could be enrolled onto one of three decitabine dose levels (60 mg/m2 delivered over three days, 100 mg/m2 delivered over five days, or 140 mg/m2 delivered over seven days) On the day following the final dose of decitabine, standard induction chemotherapy will begin. Participation in this study may last for up to 3 months. |
6
| Disease Status and/or Stage | Untreated AML or Advanced MDS |
|---|---|
| Protocol Title | A Phase I/II Evaluation of VNP4010M (Laromustine), a Sulfonylhydrazine Alkylating Agent, combined with infusional Cytarabine in Elderly Patients with Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome. |
| PI | Ellen K. Ritchie, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Adults at least 60 years of age are eligible. No prior treatment for AML with myeloblative treatment. Patients may have prior treatment with a biologic therapy. Patients with MDS or AML that have evolved from MDS could have received prior low-dose cytotoxic therapy with agents such as azacytidine or low-dose Ara C. |
| Treatment Overview | Subjects will enter into one of 5 cohorts for treatment with VNP40101M (Laromustine) 200 mg/m2 (cohort -1), 300 mg/m2 (cohort 1), 400 mg/m2 (cohort 2), 500 mg/m2 (cohort 3), or 600 mg/m2 IV on day 1 over 30-60 minutes. Laromustine will be administered in combination with Ara C at 100 mg/m2/day as a continuous infusion daily for 7 days. If response to study drug occurs, the subject may be followed for 5 years past treatment. |
7
| Disease Status and/or Stage | Advanced Myelofibrosis or Transformed to AML |
|---|---|
| Protocol Title | Prospective Pilot Trial of Arsenic Trioxide (Trisenox) in Combination with Cytosine Arabinoside (Cytarabine) in Patients with Advanced or Transformed Myelofibrosis |
| PI | Gail Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients at least 18 years of age with a documented history of myelofibrosis or myelofibrosis transformed to acute myeloid leukemia. Patients must not have had prior cytotoxic chemotherpy for AML or MDS. |
| Treatment Overview | Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously twice daily from days 1-14. Triseonx will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of Trisenox. Patients may continue to receive study treatment for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated. |
8
| Disease Status and/or Stage | Relapsed or Refractory AML |
|---|---|
| Protocol Title | A Phase Ib Open Label, Multicenter, Dose Escalating Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of SNS-595 Injection in Combination with Cytarabine in Patients with Relapsed or Refractory AML |
| PI | Gail Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients with relapsed or refractory AML who have been treated with one to three induction/reinduction AML regimens. |
| Treatment Overview | Patients receive SNS-595 Injection on Days 1 and 4 in combination with a 5 day continuous IV infusion of cytarabine, followed by weekly observations until hematologic recovery. Patients may receive up to four (4) 28-day cycles. |
9
| 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. |
| 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). |
Last updated: July 30, 2008 |
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