Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
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ClinicalTrials.gov Identifier: NCT00136084 |
Recruitment Status :
Completed
First Posted : August 26, 2005
Results First Posted : March 26, 2010
Last Update Posted : December 5, 2012
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Actual Enrollment : | 238 participants |
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 |
Study Start Date : | August 2002 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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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 |
- 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%).
- 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.

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136084
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 |
Principal Investigator: | Jeffrey Rubnitz, M.D., PhD | St. Jude Children's Research Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00136084 |
Other Study ID Numbers: |
AML02 5R01CA113482 ( U.S. NIH Grant/Contract ) |
First Posted: | August 26, 2005 Key Record Dates |
Results First Posted: | March 26, 2010 |
Last Update Posted: | December 5, 2012 |
Last Verified: | November 2012 |
Leukemia,Erythroblastic, Acute Erythroblastic Leukemia, Acute Leukemia, Myeloid, Acute Myeloid Leukemia, Acute |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cytarabine Dexamethasone Prednisone Cyclophosphamide Methotrexate |
Etoposide Vincristine Daunorubicin Asparaginase Mercaptopurine Mitoxantrone Cladribine Gemtuzumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |