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One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADE arm | Experimental | ADE arm Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADE Protocol | Drug | ADE chemotherapy Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete remission (CR) rate | To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR | Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival (EFS) and overall survival(OS) | To determineevent free survival(EFS) and overall survival(OS) | 2 year |
| toxicity of chemotherapy | To assess the toxicity of chemotherapy using CTCAE 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ARUN GARG, DM | Contact | 9968588792 | arungarg_aiims@yahoo.com |
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| Day 28 ± 7 of treatment |
| clonal evolution | To evaluate clonal evolution using cytogenetics &RT-PCR panel | Day 28 ± 7 of treatment |
| minimal residual disease (MRD) | To assess minimal residual disease (MRD) by using flow cytometry | Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier |
| cardiac function | To evaluate cardiac function using 2 Dimensional Echocardiography | Day 28 ± 7 of treatment |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C060154 | DAV regimen |
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