Leukemia and Myeloproliferative Disorders
Myelodysplastic Syndrome (MDS)
1
| 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. Patient 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. |
2
| Disease Status and/or Stage | MDS at Intermediate-1 Risk |
|---|---|
| Protocol Title | A Single-Arm, Open-Label Study of the Efficacy and Safety of Lenalidomide in Combination with Cyclosporine A in Red Blood Cell Transfusion-Dependent Patients with Myelodysplastic Syndrome |
| PI | Eric Feldman , MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Diagnosis of low or intermediate-1 risk IPSS (MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33. Red blood cell (RBC) transfusion-dependent anemia as having received 2 or more units of RBCs within 8 weeks on the first day of study treatment. |
| Treatment Overview | All eligible patients will initially receive Revlimid® (lenalidomide) as single agent for 4 weeks. On Day 1 Cycle 2, cyclosporine A will be sequentially added and eligible patients will continue therapy for 12 additional weeks (16 weeks total). After completing 16 weeks of therapy, responding patients will continue the combination until evidence of disease progression or intolerable side effects occur. |
3
| Disease Status and/or Stage | Relapsed/Refractory MDS at Intermediate 2 or High Risk Score |
|---|---|
| Protocol Title | A Phase IIa, Open-label, Randomized Dose Confirmation Study of Oral Clofarabine in Previously Treated Adult Patients with Myelodysplastic Syndromes (MDS) |
| PI | Gail J. Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Adults 18 years or greater who have received at least one but no more than two prior treatment regimens for MDS. Must have received either 5-azacytidine or decitabine. Patients must not have been refractory to more than one prior treatment regimen. |
| Treatment Overview | Patients will be randomly assigned to one of two clofarabine doses: 35 mg or 55 mg administered orally for 5 days -- may be repeated every 4-8 weeks Frequent clinic visits will be required for monitoring. Treatment may be continued as long as the patient continues to benefit but may not exceed 8 cycles. |
4
| Disease Status and/or Stage | Low or Intermediate 1- Risk Myelodysplastic Syndromes (MDS) |
|---|---|
| Protocol Title | A Phase I, Open-Label, Dose-Escalation Study of CC-11006 in Subjects with Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) |
| PI | Gail J. Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients must have tried and failed one or more conventional first-time treatments for MDS with anemia including Revlimid, recombinant erythropoietins, 5-azacitidine, decitibine or other associated therapies. |
| Treatment Overview | Cohorts of 3 subjects will receive escalating doses of CC-11006 until the Maximum Tolerated Dose is determined. Dosing will begin at the 10 mg/day dose-level. Subjects may participate in this study for up to 24 months depending on response to the study drug. |
5
| Disease Status and/or Stage | Low or Intermediate 1- Risk Myelodysplastic Syndromes (MDS) |
|---|---|
| Protocol Title | A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) |
| PI | Gail J. Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | IPSS low or intermediate-1 risk MDS who have never received any disease-modifying treatment for MDS |
| Treatment Overview | Subjects will be randomized in a 2:1 allocation to receive romiplostim or placebo weekly via subcutaneous injection during a 26-week test treatment period and subsequent 24-week extended treatment period. |
6
| Disease Status and/or Stage | Low or Intermediate Risk Myelodysplastic Syndromes (MDS) |
|---|---|
| Protocol Title | A Randomized, Double Blind, Placebo Contolled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects with Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents |
| PI | Gail J. Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Subjects must have a diagnosis of low, intermediate 1- or intermediate 2-risk MDS and plan to receive decitabine according to the approved label for at least 4 cycles. |
| Treatment Overview | Subjects will be randomized to receive either the study drug, AMG531 or placebo. After 4 cycles of treatment, subjects may be unblinded and if appropriate, those subjects receiving placebo may begin treatment with AMG531. |
7
| 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. |
8
| 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: March 20, 2009 |
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