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To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ruxolitinib, vincristine, prednisone | Experimental | Open label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Dose escalation up to 80 mg administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish optimal dose of ruxolitinib | Determine maximum tolerated dose (MTD) of ruxolitinib | Upon completion of a 28 day treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety by assessing toxicities | Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting. | Upon completion of a 28 day treatment cycle |
| Overall response |
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Inclusion Criteria:
Subjects with early T-precursor ALL, with any of the following:
Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
Greater than 5% blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Ji, MD | Contact | 86-18980605802 | jieji@scu.edu.cn | |
| Ting Liu, MD | Contact | 86-28-85422370 | liuting@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jie Ji, MD | West Chinia Hospital, Sichuan University | Principal Investigator |
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| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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Open label dosing cohorts will evaluate oral ruxolinitib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).
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| Vincristine | Drug | 1.4 mg/m2 i.v. weekly for 4 weeks |
|
|
| Prednisone | Drug | 1 mg/kg orally 5 consecutive days per week for 4 weeks. |
|
|
| At the end of Cycle 2 (each cycle is 60 days) |
| Complete response | At the end of Cycle 2 (each cycle is 60 days) |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |