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Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
This study has been completed.
Sponsor:
St. Jude Children's Research Hospital
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00136084
First received: August 24, 2005
Last updated: November 2, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Leukemia, Myelocytic, Acute | Drug: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone Drug: Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia |
Resource links provided by NLM:
Genetics Home Reference related topics:
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
Drug Information available for:
Cytarabine
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
Myelodysplastic Syndromes
Acute Erythroid Leukemia
Di Guglielmo's Syndrome
U.S. FDA Resources
Further study details as provided by St. Jude Children's Research Hospital:
Primary Outcome Measures:
- Minimal Residual Disease (MRD). [ Time Frame: Day 22 MRD measurement ]Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%).
Secondary Outcome Measures:
- Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) [ Time Frame: Consolidation I ]To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)
- Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO [ Time Frame: Induction II ]To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.
- Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. [ Time Frame: Induction II ]To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy
- To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy [ Time Frame: Five Year ]Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up
- To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy [ Time Frame: Measurements were assessed in Induction I chemotherapy ]Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.
- Relationship of Inhibition of DNA Synthesis and Clinical Response [ Time Frame: Measurements were assessed in Induction I chemotherapy ]Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.
| Enrollment: | 238 |
| Study Start Date: | August 2002 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HDAC (High-Dose Cytarabine)
Since limited characters are allowed in this passage, please see detailed Description for HDAC.
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Drug: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone
Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
|
|
Experimental: LDAC (Low-Dose Cytarabine)
Since limited characters are allowed in this passage, please see detailed Description for LDAC.
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Drug: Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine
Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of acute myeloid leukemia by immunophenotyping, morphology, and cytochemical staining; myelodysplasia; or biphenotypic leukemia.
- Age less than or equal to 21 years at time of study entry.
- No prior therapy for this malignancy (patients with secondary AML following treatment of primary malignancy are eligible) except for one dose of intrathecal therapy.
- Negative pregnancy test
- Patient does not have Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Exclusion Criteria:
- Positive pregnancy test
- Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136084
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136084
Locations
| United States, California | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94304 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Children's Hospital of Michigan (Wayne State University) | |
| Detroit, Michigan, United States, 48201 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Jeffrey Rubnitz, M.D., PhD | St. Jude Children's Research Hospital |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00136084 History of Changes |
| Other Study ID Numbers: |
AML02 5R01CA113482 ( U.S. NIH Grant/Contract ) |
| Study First Received: | August 24, 2005 |
| Results First Received: | March 5, 2010 |
| Last Updated: | November 2, 2012 |
Keywords provided by St. Jude Children's Research Hospital:
|
Leukemia,Erythroblastic, Acute Erythroblastic Leukemia, Acute Leukemia, Myeloid, Acute Myeloid Leukemia, Acute |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Dexamethasone Prednisone Gemtuzumab Cyclophosphamide Methotrexate |
Etoposide Cytarabine Vincristine Mitoxantrone Daunorubicin Asparaginase 6-Mercaptopurine Cladribine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids |
ClinicalTrials.gov processed this record on September 21, 2017