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This trial is a multicenter prospective, open, non-intervention clinical study. 200 patients with newly diagnosed adult ALL who underwent induction remission with the VDCLD regimen containing PLD and DNR, respectively,were plan to enrolled in this study to evaluate the CR rate and the level of myeloid leukemia stem cells in the first course of chemotherapy with two regimens; and to evaluate the safety of the two induction chemotherapy regimens.
Subjects will receive one of two treatment regimens:
Group A: intravenous drip of liposomal doxorubicin 36 mg/m2, d1、d15,1h; VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip,once every 28days.
Group B: intravenous drip of DNR45mg/m2,d d1~3,1h;VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip,once every 28days. The primary endpoint is complete remission after the first course treatment of induced remission chemotherapy, to evaluated the ratio of CR patients after the first course of chemotherapy with PLD and DNR VDCLD regimens.The secondary endpoint is to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VDCLD regimen containing PLD | PLD 36mg/㎡.d d1、d15,ivdrip,1h,VCR 1.4mg/㎡.d d1,d8,d15,d22 iv,CTX 800mg/㎡.d d1 ivdrip,L-asp 6000u/㎡.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip |
| |
| VDCLD regimen containing DNR | DNR 45mg/㎡.d d1~3,ivdrip,1h,VCR 1.4mg/㎡.d d1,d8,d15,d22 iv,CTX 800mg/㎡.d d1 ivdrip,L-asp 6000u/㎡.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLD | Drug | PLD36mg/m2.d d1、d15,ivdrip,1h,VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR | complete remission after the first course treatment of induced remission chemotherapy | From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| changes of myeloid leukemia stem cells | to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively. | From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical trial will evaluate patients with primary adult ALL who meet the aboving inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiandong nie, doctor | Contact | 0311-66575708 | niejd@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| zhigang yang, doctor | Affiliated Hospital of Guangdong Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Guangdong Medical University | Recruiting | Guangdong | Guangdong | 524001 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C041277 | 1-dodecylpyridoxal |
| C506643 | liposomal doxorubicin |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| DNR | Drug | DNR 45mg/m2.d d1~3,ivdrip,1h,VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip |
|
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |