Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136084
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2005-08-24
Brief Title:
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia
Detailed Description:
The study compares the effectiveness of two doses of cytarabine combined with set doses of daunomycin and etoposide as an initial course of chemotherapy to eliminate minimal residual disease Subsequent therapy is tailored according to cytogenetic risk features assessments of minimal residual disease and availability of a suitable donor for bone marrow transplant Patients with higher risk disease features are given more intense therapy For higher risk groups transplant is given to patients with suitable donors
Secondary objectives include
To assess the prognostic value of biological markers in childhood Acute Myeloid leukemia AML
To compare the amounts of leukemia cells in the blood and bone marrow to study minimal residual diseaseMRD
To relate non-invasive cardiac evaluation with health-related quality of life in AML patients treated with cardiotoxic therapy during and following therapy
Detailed Description of Treatment Plan Induction I Patients will be randomly assigned to receive induction therapy that consists of daunomycin etoposide and high-dose or low-dose cytarabine
High-Dose Cytarabine HDAC arm
Cytarabine 3 gmm2 IV days 1 3 5 Daunomycin 50 mgm2 IV days 2 4 6 Etoposide 100 mgm2 IV days 2-6
Low-Dose CytarabineLDAC arm
Cytarabine 100 mgm2 IV days 1-10 20 doses Daunomycin 50 mgm2 IV days 2 4 6 Etoposide 100 mgm2 IV days 2-6
Induction II
Patients who have 1 MRD after Induction I will receive daunomycin cytarabine etoposide ADE
Daunomycin 50 mgm2 IV days 1 3 5 Cytarabine 100 mgm2 IV 1-8 16 doses Etoposide 100 mgm2 IV days 1-5
Patients who have 1 MRD after Induction I will receive daunomycin cytarabine etoposide ADE gemtuzumab ozogamicin
Daunomycin 50 mgm2 IV days 1 3 5 Cytarabine 100 mgm2IV days 1-8 16 doses Etoposide 100 mgm2 IV on days 1-5 Gemtuzumab ozogamicin GO 3 mgm2 IV on day 1
Consolidation I Chemotherapy course 3
The chemotherapy administered in course 3 will be based on the participants response and cytogeneticmorphologic subgroup
MRD patients except those who received ADE GO Gemtuzumab ozogamicin 6 mgm2 IV on day 1
MRD patients who had No responseNR to induction I
These patients should proceed to Stem Cell Transplant SCT as soon as possible In cases where SCT is delayed eg during searches for unrelated donors these patients should receive chemotherapy according to their cytogenetic or morphologic subtype until the time of SCT
MRD- patients ie patients who were MRD- after ADE or after GO will receive risk-based intensification RBI
t911 and inv16 Cytarabine 500 mgm2day by continuous infusion for 120 hours Cladribine 2CDA 9 mgm2 IV over 30 minutes daily for 5 days
Amend 8 M4M5 without t911 or inv16 CE Cytarabine 3 gmm2 IV q12h x 6 doses days 1-3 by continuous infusion for 3 hours Etoposide 125 mgm2 IV on days 2-5 by continuous infusion for at least one hour
t821 and others HAM Cytarabine 3 gm2 IV x 6 doses days 1-3 Mitoxantrone 10 mgm2 IV days 3-4
Standard-risk patients with matched related donors and high-risk patients will proceed to stem cell transplant per institutional practice
Consolidation II Chemotherapy course 4
Cytarabine 3 gmm2 IV q12 hours on days 1 2 8 9 8 doses L-Asparaginase 6000 Unitsm2 IM 3 hours after 4th and 8th doses of cytarabine
Consolidation III Chemotherapy course 5 Mitoxantrone 10 mgm2 IV days 1-3 Cytarabine 1 gmm2 IV over 2 hours q12 hours on days 1-3 6 doses
Patients who are in first remission are eligible to be enrolled on the St Jude protocols NKAML protocol and receive Natural Killer NK cell therapy instead of Consolidation III or after Consolidation III At the discretion of their primary physician these patients will be offered the option of enrolling on NKAML
Some patients with biphenotypic leukemia respond poorly to AML-directed therapy but respond quite well to lymphoid-directed therapy Patients with such markers who have no response to induction I or who fail to achieve complete response CR after induction II will therefore receive lymphoid directed induction therapy Other biphenotypic patients will continue to receive AML-directed therapy as described above
All patients will undergo lumbar puncture and receive an age-appropriate dose of intrathecal IT cytarabine at the time of diagnosis
Patients without Central Nervous System disease CNSie less than 5 leukocytes per microliter of CSF colony-stimulating factor will receive one dose of intrathecal IT methotrexate hydrocortisone and cytarabine MHA with each course of chemotherapy beginning with induction II
Patients with overt CNS leukemia more or equal to 5 leukocytes per l microliter of CSF and the presence of leukemic blast cells on CSF cytospin will receive weekly IT MHA therapy beginning 1 week after the initial dose of IT cytarabine and continuing until the CSF is free of blast cells minimum number of doses 4 These patients will then receive 4 additional doses of intrathecal therapy with methotrexate hydrocortisone and cytarabine IT MHA minimum total number of doses 8 at approximately 1-month intervals generally given with each subsequent course of chemotherapy
Secondary objectives include
To assess the prognostic value of biological markers in childhood Acute Myeloid leukemia AML
To compare the amounts of leukemia cells in the blood and bone marrow to study minimal residual diseaseMRD
To relate non-invasive cardiac evaluation with health-related quality of life in AML patients treated with cardiotoxic therapy during and following therapy
Detailed Description of Treatment Plan Induction I Patients will be randomly assigned to receive induction therapy that consists of daunomycin etoposide and high-dose or low-dose cytarabine
High-Dose Cytarabine HDAC arm
Cytarabine 3 gmm2 IV days 1 3 5 Daunomycin 50 mgm2 IV days 2 4 6 Etoposide 100 mgm2 IV days 2-6
Low-Dose CytarabineLDAC arm
Cytarabine 100 mgm2 IV days 1-10 20 doses Daunomycin 50 mgm2 IV days 2 4 6 Etoposide 100 mgm2 IV days 2-6
Induction II
Patients who have 1 MRD after Induction I will receive daunomycin cytarabine etoposide ADE
Daunomycin 50 mgm2 IV days 1 3 5 Cytarabine 100 mgm2 IV 1-8 16 doses Etoposide 100 mgm2 IV days 1-5
Patients who have 1 MRD after Induction I will receive daunomycin cytarabine etoposide ADE gemtuzumab ozogamicin
Daunomycin 50 mgm2 IV days 1 3 5 Cytarabine 100 mgm2IV days 1-8 16 doses Etoposide 100 mgm2 IV on days 1-5 Gemtuzumab ozogamicin GO 3 mgm2 IV on day 1
Consolidation I Chemotherapy course 3
The chemotherapy administered in course 3 will be based on the participants response and cytogeneticmorphologic subgroup
MRD patients except those who received ADE GO Gemtuzumab ozogamicin 6 mgm2 IV on day 1
MRD patients who had No responseNR to induction I
These patients should proceed to Stem Cell Transplant SCT as soon as possible In cases where SCT is delayed eg during searches for unrelated donors these patients should receive chemotherapy according to their cytogenetic or morphologic subtype until the time of SCT
MRD- patients ie patients who were MRD- after ADE or after GO will receive risk-based intensification RBI
t911 and inv16 Cytarabine 500 mgm2day by continuous infusion for 120 hours Cladribine 2CDA 9 mgm2 IV over 30 minutes daily for 5 days
Amend 8 M4M5 without t911 or inv16 CE Cytarabine 3 gmm2 IV q12h x 6 doses days 1-3 by continuous infusion for 3 hours Etoposide 125 mgm2 IV on days 2-5 by continuous infusion for at least one hour
t821 and others HAM Cytarabine 3 gm2 IV x 6 doses days 1-3 Mitoxantrone 10 mgm2 IV days 3-4
Standard-risk patients with matched related donors and high-risk patients will proceed to stem cell transplant per institutional practice
Consolidation II Chemotherapy course 4
Cytarabine 3 gmm2 IV q12 hours on days 1 2 8 9 8 doses L-Asparaginase 6000 Unitsm2 IM 3 hours after 4th and 8th doses of cytarabine
Consolidation III Chemotherapy course 5 Mitoxantrone 10 mgm2 IV days 1-3 Cytarabine 1 gmm2 IV over 2 hours q12 hours on days 1-3 6 doses
Patients who are in first remission are eligible to be enrolled on the St Jude protocols NKAML protocol and receive Natural Killer NK cell therapy instead of Consolidation III or after Consolidation III At the discretion of their primary physician these patients will be offered the option of enrolling on NKAML
Some patients with biphenotypic leukemia respond poorly to AML-directed therapy but respond quite well to lymphoid-directed therapy Patients with such markers who have no response to induction I or who fail to achieve complete response CR after induction II will therefore receive lymphoid directed induction therapy Other biphenotypic patients will continue to receive AML-directed therapy as described above
All patients will undergo lumbar puncture and receive an age-appropriate dose of intrathecal IT cytarabine at the time of diagnosis
Patients without Central Nervous System disease CNSie less than 5 leukocytes per microliter of CSF colony-stimulating factor will receive one dose of intrathecal IT methotrexate hydrocortisone and cytarabine MHA with each course of chemotherapy beginning with induction II
Patients with overt CNS leukemia more or equal to 5 leukocytes per l microliter of CSF and the presence of leukemic blast cells on CSF cytospin will receive weekly IT MHA therapy beginning 1 week after the initial dose of IT cytarabine and continuing until the CSF is free of blast cells minimum number of doses 4 These patients will then receive 4 additional doses of intrathecal therapy with methotrexate hydrocortisone and cytarabine IT MHA minimum total number of doses 8 at approximately 1-month intervals generally given with each subsequent course of chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01CA113482 | NIH | None | httpsreporternihgovquickSearch5R01CA113482 |