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 | Untreated AML |
|---|---|
| Protocol Title | Phase IIb Multicenter, Randomized, Open-label Trial of CPX (Cytarabine: Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients with Untreated AML 60-75 Years of Age |
| PI | Eric Feldman, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients between the ages of 60 and 75 years old and have documented pathological confirmation of AML. Patients must be untreated: only hydroxyurea is permitted. |
| Treatment Overview |
Patients will be randomized to one of two arms: Arm A: CPX-351 will be administered intravenously (100u/m2) on Days 1, 3, 5 Arm B: Standard "7 + 3" intensive therapy. Patients may receive a second induction regimen of either CPX-351 or"7+3" depending on which arm the patient was randomized to. Patients with documented CR are eligible for consolidation therapy. |
3
| Disease Status and/or Stage | First Relapse AML |
|---|---|
| Protocol Title | Phase IIB, Multicenter, Randomized, Open-Label Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection versis Intensive Salvage Therapy in Adult Patients 60 years or younger with AML in First Relapse Following an Initial Complete Response greater than 1 Month Duration |
| PI | Eric Feldman, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients need to be between the ages of 18 and 60 years old and have documented pathological confirmation of relapsed AML after initial complete remission of a greater than 1 month duration. |
| Treatment Overview |
Patients will be randomized to one of two arms: Arm A: CPX-351 will be administered intravenously (100u/m2) on Days 1, 3, 5 Arm B: Standard intensive salvage therapy. Patients may receive a second induction. The second CPX-351 induction is only administered on Days 1 and 3. For the control arm intensive salvage therapy is permitted and second inductions are to be administered according to local practice. Patients with documented CR are eligible for consolidation therapy. |
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
7| 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 | Relapsed or Refractory Hematologic Malignancies |
|---|---|
| Protocol Title | A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients with Select, Relapsed or Refractory Hematologic Malignancies |
| PI | Richard Furman , MD |
| Contact | Patricia Glynn, RN 212-746-6738 |
| Key Eligibility | CLL patients who are refractory to or relapsed after at least 2 prior therapies, including fludarabine, alone or in combination. Patients must be symptomatic. |
| Treatment Overview | The study drug should be taken twice a day. The patient should take the morning dose with water on an empty stomach; food can be consumed at least an hour after dosing. The evening dose should be taken with water approximately 12 hours after the morning dose and at least 2 hours after a Each patient will be assessed for clinical response after completing 1 cycle of 28 days of treatment. Treatment may continue for up to a total of 6 cycles. |
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 | Myelodysplastic Syndrome or Acute Myelogenous Leukemia |
|---|---|
| Protocol Title | A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplantation in Patients with Myelodysplastic Syndrome or Acute Myelogenous Leukemia. |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | The diagnosis of MDS or AML requiring chemotherapy prior to stem cell transplant. Donors must be related or unrelated who are genotypically or phenotypically matched by high resolution HLA typing. |
| Treatment Overview | Patients will be randomly assigned to a myeloablative conditioning regimen (Fludarabine, Busulfan, Cyclophosphamide) or a nonmyeloablative conditioning regimen (Fludarabine + TBI). The post transplant immunosuppression will include will receive Cyclesporine and Mycophenolate Mofetil for the nonmyeloablative patients, and Tacrolimus and methotrexate for the myeloablative patients. |
10
| 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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