Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

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Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neoplasm, Residual

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Neoplastic Processes

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

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Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Cytarabine

Fludarabine

Fludarabine phosphate

Methotrexate

Vidarabine

Clofarabine

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Folinic Acid

Folate

Vitamin B9

A maximum of two courses of the following regimen will be administered.

* Clofarabine: 20 mg/m2/day intravenously (IV) over 2 hours (given at hours 0 to 2) on days 1 through 5.
* Cytarabine intravenous: 1 gram/m2/day intravenously (IV) over 2 hours to be given 4 hours after the initiation of clofarabine on days 1 through 5.
* Methotrexate: to be given intrathecally (IT) to all acute lymphoblastic leukemia (ALL) patients on day 1 at the dose defined by age.
* Intrathecal (IT) cytarabine: is optional for acute myelogenous leukemia (AML) patients.

20 mg/m2/day intravenously (IV) over 2 hours (given at hours 0 to 2) on days 1 through 5.

1 gram/m2/day intravenously (IV) over 2 hours to be given 4 hours after the initiation of clofarabine on days 1 through 5.

Cytarabine intravenous

Methotrexate to be given intrathecally (IT) to all acute lymphoblastic leukemia (ALL) patients on day 1 at the dose defined by age below:

* 8 mg for patients age 1-1.99
* 10 mg for patients age 2-2.99
* 12 mg for patients 3-8.99 years of age
* 15 mg for patients \>9 years of age

Intrathecal (IT) cytarabine is optional for acute myelogenous leukemia (AML) patients.

If intrathecal cytarabine is to be given, it must be given at least 72 hours but not more than 7 days prior to the initiation of intravenous cytarabine.

Dose should be given according to age as defined below:

* 30 mg for patients age 1-1.99
* 50 mg for patients age 2-2.99
* 70 mg for patients \>3 years of age

Intrathecal (IT) Cytarabine

Blythe Thomson, MD

This study will test the ability of clofarabine + cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen will be evaluated in addition to toxicity experienced by patients who proceed to stem cell transplant. Overall length of remission will also be collected.

Recent studies have demonstrated that even low levels of minimum residual disease (MRD) (\>0.01% abnormal blasts) after aggressive re-induction therapy indicate a relatively poor outcome in relapsed acute lymphoblastic leukemia (ALL) patients, including those who proceed to allogeneic stem cell transplant (alloSCT). A similarly poor prognosis was seen in pediatric acute myelogenous leukemia patients with sub-morphologic disease prior to alloSCT. Studies to identify therapies that can eliminate persistent leukemia, have low toxicity profiles and can serve as a bridge to transplant are needed.

This study will test the ability of clofarabine + cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia and acute lymphoblastic leukemia patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen will be evaluated in addition to toxicity experienced by patients who proceed to stem cell transplant. Overall length of remission will also be collected.

Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Clofarabine With Cytarabine for MRD Positive Leukemia

To be assessed in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. Patient's bone marrow will be evaluated for the amount of minimal residual disease (MRD) present after treatment on courses 1 and 2.

Treatment related toxicities that preclude proceeding to HSCT by day 56 of the treatment course.

After the patient completes therapy on this protocol, data will continue to be collected regarding whether the patient proceeded to HCT. Toxicity and adverse event information will be collected.

Genzyme, a Sanofi Company

Therapeutic Advances in Childhood Leukemia Consortium

The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.

Clofarabine, Cytarabine, Methotrexate

See detailed description in Interventions section.

Single Arm

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study only enrolled two patients and closed early due to low accrual.

Peggy Romano, BA, CCRP

Study was closed prematurely and none of the patients treated were eligible for analysis of disease response.

Minimal Residual Disease (MRD)

All patients treated on Treatment Course 1.

Number of Patients With Dose-Limiting Toxicity (DLT)

None of the patients treated on Treatment Course 1 proceeded to HCT. 1 patient upon completion of Treatment Course 1 proceeded with Bone Marrow Transplant and 1 patient was removed early from protocol treatment during Course 1 due to progressive disease.

Occurrence of Toxicity During Hematopoietic Cell Transplant (HCT) for Patients Who Achieve Remission and Proceed to Transplant

Treatment Course 1

Treatment Course 2

Amino Acids

Dasatinib

Idarubicin

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tyrosine

Study participants #1 - #6 receive dose level 1 of dasatinib (60/mg/m2/day) in addition to the standard treatment, for up to 2 courses. Each treatment course is 29 days.

Treatment course 1 consists of:

* Fludarabine at a dose of 30mg/m2, intravenously once daily on days 1-5
* Cytarabine at a dose of 2000mg/m2, intravenously once daily on days 1-5
* Idarubicin at a dose of 8mg/m2, intravenously once daily on days 3-5
* Intrathecal cytarabine on day 1 according to standard age specific dosing guidelines
* Dasatinib orally, once daily on days 6-29

Participants achieving a response of standard disease or better are eligible for course 2 consisting of dasatinib with fludarabine and cytarabine alone.

Study participants # 7 - # 12 receive dose level 2 of dasatinib (80/mg/m2/day) in addition to the standard treatment (up to 2 courses), if the participants receiving Dose Level 1 did not experience intolerable side effects. Each treatment course is 29 days.

Treatment course 1 consists of:

* Fludarabine at a dose of 30mg/m2, intravenously once daily on days 1-5
* Cytarabine at a dose of 2000mg/m2, intravenously once daily on days 1-5
* Idarubicin at a dose of 8mg/m2, intravenously once daily on days 3-5
* Intrathecal cytarabine on day 1 according to standard age specific dosing guidelines
* Dasatinib orally, once daily on days 6-29

Participants achieving a response of standard disease or better are eligible for course 2 consisting of dasatinib with fludarabine and cytarabine alone.

Study participants # 13 - # 18 receive dose level 3 of dasatinib (100/mg/m2/day) in addition to the standard treatment (up to 2 courses), if the participants receiving Dose Level 2 did not experience intolerable side effects. Each treatment course is 29 days.

Treatment course 1 consists of:

* Fludarabine at a dose of 30mg/m2, intravenously once daily on days 1-5
* Cytarabine at a dose of 2000mg/m2, intravenously once daily on days 1-5
* Idarubicin at a dose of 8mg/m2, intravenously once daily on days 3-5
* Intrathecal cytarabine on day 1 according to standard age specific dosing guidelines
* Dasatinib orally, once daily on days 6-29

Participants achieving a response of standard disease or better are eligible for course 2 consisting of dasatinib with fludarabine and cytarabine alone.

Administered orally on a once daily schedule based on the dose level assigned to the patient at enrollment (60, 80, or 100mg/m2/day). Patients may adjust the time they take dasatinib as long as they take the drug approximately every 24 hours

30 mg/m2/dose, intravenous infusion over 30 minutes, once daily, on days 1 to 5, total 5 doses

Participants with body weight less than 12Kg, the fludarabine dose will be corrected as follows: \[weight (Kg) x dose (per m2)\] divided by 30

2000 mg/m2/dose intravenous infusion over 1 to 3 hours, starting 4 hours after the beginning of fludarabine, once daily, on days 1 to 5, total 5 doses

Participants with body weight less than 12Kg, the cytarabine dose will be corrected as follows: \[weight (Kg) x dose (per m2)\] divided by 30

8mg/m2/dose intravenous infusion over 15 minutes, once daily, on days 3 to 5, total 3 doses

Participants with body weight less than 12Kg, the idarubicin dose will be corrected as follows: \[weight (Kg) x dose (per m2)\] divided by 30

Given intrathecally to all participants on day 1 of course 1 and 2. Omit on day 1 of course 1 if participant received IT therapy within 7 days prior to study enrollment. Intrathecal chemotherapy may be given during the end of course 1 disease evaluation (spinal fluid and bone marrow aspiration) and may be repeated every 7 days with bone marrow evaluations per institutional preference.

Cytarabine dose defined by age:

* 30 mg for patients age 1 - 1.99
* 50 mg for patients age 2 - 2.99
* 70 mg for patients ≥3 years of age

The participant may receive intrathecal triple therapy (ITT) if persistent blasts are present in the cerebral spinal fluid (CSF) based on the treating physician's clinical judgment.

Intrathecal (IT) cytarabine

Melinda Pauly, MD

This study will examine the appropriate dose and side effects of dasatinib, when it is given with the standard of care chemotherapy for children and adolescents with Acute Myeloid Leukemia (AML).

This Phase I study is for children and adolescents who have acute myelogenous leukemia (AML) that has come back (relapsed) or has become resistant (refractory) to standard therapies. Researchers want to know if a drug called dasatinib is safe when used together with standard chemotherapy in treating patients who have relapsed or have resistant AML. Their leukemia has a particular genetic mutation, called core-binding factor.

This type of leukemia has an increase of a cancer promoting protein called c-KIT. Dasatinib can target this protein in laboratory experiments. Laboratory and other studies suggest that dasatinib may prevent acute myeloid leukemia cells from growing and may lead to the destruction of leukemia cells.

The main goal of this study is to find a safe dose of dasatinib and to find out the side effects of dasatinib when it is given in combination with standard chemotherapy to children and adolescents. Similar studies are currently being done in adult patients. Dasatinib has been proven safe and effective in the treatment of other types of leukemia, both by itself and in combination with standard chemotherapy. It is not, however, FDA-approved for use in children.

Three to six participants will receive the starting dose of the drug. If the side effects are not too severe, the next group of participants will take the study drug at a higher dose level. Up to two dose levels of the study drug will be tested. Dasatinib is given by mouth once daily on days 6 to 29 of each 42-day cycle. Participants may receive two cycles in this study.

In addition to dasatinib, participants receive chemotherapy intravenously (IV) with fludarabine, cytarabine, idarubicin, as well as in the spinal fluid (intrathecal or IT chemotherapy). Intrathecal chemotherapy includes cytarabine at the start of each cycle. These drugs are part of standard AML treatment. If at the time of study entry a subject has leukemia cells in their spinal fluid (CNS leukemia), they may receive additional intrathecal chemotherapy with cytarabine, methotrexate, and hydrocortisone (IT triples) during each cycle.

Required research tests include pharmacokinetic (PK) and pharmacodynamics (PD) blood draws (about 1 teaspoon each time) during cycle 1. Optional research tests include extra marrow (about 1 teaspoon each time) for genetic testing and banking of marrow (1 teaspoon) for future studies about cancer.

Primary Objectives of this study are:

* To evaluate the safety of combining dasatinib with reinduction chemotherapy comprised of idarubicin, fludarabine and cytarabine (Ida - FLU/Ara) in children with relapsed or refractory core binding factor acute myeloid leukemia (CBF AML)
* To characterize the toxicity profile of this combination in pediatric patients with relapsed or refractory CBF AML

Secondary Objectives of this study are:

* To estimate the response rates to the combination chemotherapy in the context of a Phase I study, in children with AML in first or greater relapse or refractory to induction chemotherapy
* To determine the genotype of c-KIT exons 8 and 17 and correlate with response rate
* To characterize c-KIT expression of bone marrow blasts at study entry and at the end of course 1 of therapy and describe any correlation with response to therapy

Exploratory Objectives are:

* To investigate descriptively the pharmacodynamic modulation of c-KIT target, Stat3, in a cell line by patient-derived plasma
* To perform RNA sequencing on bone marrow samples at study entry in order to describe the prevalence of mutations in AML associated genes, including c-KIT, and correlate descriptively with progression free survival
* To collect biology specimens at study entry and completion of therapy for future biology studies

Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia

Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia: A Phase I Study (AflacLL1401)

The number of adverse events throughout the duration of the study will be collected to assess the safety of dasatinib.

The number of dose limiting toxicities (DLT) as defined by grade 3 or higher non-hematologic adverse events persisting for great than 48 hours without resolution to a grade 2 or less, grade 2 pleural effusion that persists longer than 1 week, failure to recover an absolute neutrophil count (ANC) of greater than 500/µL, and platelet count of greater than 50,000/µL. Dose level toxicities will be assessed in the first course only.

The MTD will be the highest dose at which 1 or fewer of six patients experience dose-limiting toxicities (DLT).

A single bone marrow aspiration/biopsy will be performed to assess remission status between day 29 and 43. The exact time point of the bone marrow aspiration/biopsy is dependent on blood count recovery (absolute neutrophil count of greater than 500). Day 43 is the last day remission status must be assessed.

The effect of dasatinib on c-KIT expression will be measured by phosphorylation of Stat3 in a core binding factor acute myeloid leukemia (CBF AML) cell line treated with patient plasma.

Emory University

Acute Disease

Disease Attributes

Childhood Acute Lymphoblastic Leukemia

Anti-Inflammatory Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Azacitidine

Participants with Acute Myeloid Leukemia (AML)

Intervention:

* Azacytidine (Dose Level 1 @ 75 mg/m2/day)
* Fludarabine 30 mg/m2/dose
* Cytarabine 2000 mg/m2/dose
* Intrathecal (IT) Cytarabine

Patients with Acute Lymphocytic Leukemia

Intervention:

* Azacytidine (Dose Level 1 @ 75 mg/m2/day)
* Fludarabine 30 mg/m2/dose
* Cytarabine 2000 mg/m2/dose
* Intrathecal Methotrexate (IT MTX)

Dose assigned at study entry (75 mg/m2/day). Given subcutaneously, once daily on days 1 to 5, for a total of 5 doses.

Azacytidine

30 mg/m2/dose, intravenous infusion over 30 minutes, once daily, on days 6 to 10, total 5 doses

2000 mg/m2/dose intravenous infusion over 3 hours, starting 4 hours after the beginning of fludarabine, once daily, on days 6 to 10, total 5 doses.

Intrathecally to AML patients on day 1 of course 1 and 2.

* Omit on day 1 of course 1 if patient received IT therapy within 7 days prior to study enrollment
* IT therapy may be given during the end of course 1 disease evaluation and repeated every 7 days
* For patients with CNS disease, IT cytarabine can be given weekly until the CSF is clear. Two additional doses of IT cytarabine should be given weekly after the initial CSF clearing. It is permitted to change to intrathecal triple therapy (ITT) if persistent blasts are present in the CSF based on the treating physician's clinical judgment. Cytarabine dose defined by age:
* 30 mg for patients age 1-1.99
* 50 mg for patients age 2-2.99
* 70 mg for patients \>3 years of age

ITT Dosing:

Age (yrs) - Dose Methotrexate (MTX), Hydrocortisone (HC), Cytarabine (ARAC):

1. - 1.99 MTX: 8 mg, HC: 15 mg, ARAC: 30 mg
2. - 2.99 MTX: 10 mg, HC: 25 mg, ARAC: 50 mg

   * 3 - MTX: 12 mg, HC: 35 mg, ARAC: 70 mg

* Intrathecally to patients with ALL on day 1 of course 1 and 2.
* Omit IT MTX on Day 1 of course 1 if patient received IT therapy within 7 days prior to study enrollment
* IT therapy may be given during the end of course 1 disease evaluation and repeated every 7 days
* For patients with CNS 2 or 3 disease, IT MTX can be given weekly until the CSF is clear. Two additional doses of IT MTX should be given weekly after the initial clearing of the CSF. It is permitted to change to ITT if persistent blasts are present in the CSF. Methotrexate dose defined by age
* 8 mg for patients age 1-1.99
* 10 mg for patients age 2-2.99
* 12 mg for patients 3-8.99 years of age
* 15 mg for patients \>9 years of age

Triple IT Therapy Dosing:

Age (yrs): Dose Methotrexate (MTX), Hydrocortisone (HC), Cytarabine (ARAC):

1. - 1.99 MTX: 8 mg, HC: 8 mg, ARAC: 16 mg
2. - 2.99 MTX: 10 mg, HC: 10 mg, ARAC: 20 mg
3. - 8.99 MTX: 12 mg, HC: 12 mg, ARAC: 24 mg

   * 9 MTX: 15 mg, HC: 15 mg, ARAC: 30 mg

Intrathecal Methotrexate (IT MTX)

Weili Sun, MD, PhD

This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.

Growing evidence indicates that aberrant DNA hypermethylation is associated with leukemia development, drug resistance, and relapse. It has been shown that pretreating leukemia cells with AZA or decitabine could partially reverse the aberrant DNA methylation, restore the expression of tumor suppressor gene important for apoptosis, and sensitize cells to subsequent killing by cytotoxic agent. Since cytarabine and decitabine share the same mechanisms of resistance, we use AZA to test the novel epigenetic "priming" approach. This is a phase I clinical study with expansion phase, using hypomethylating agent, 5-azacytidine (AZA), in sequential with chemotherapy to evaluate whether epigenetic "priming" can reverse aberrant DNA methylation, overcome drug resistance, and increase response in relapsed/refractory AML.

The chemotherapy regimen to be used in this study is fludarabine and cytarabine. This regimen has substantial activity in leukemia and has been widely used in treating pediatric patients with relapsed/refractory AML and ALL in the past several decades. In BFM relapsed AML 2001/01 study, FLAG (fludarabine, cytarabine and G-CSF) chemotherapy regimen showed significant activity in AML with 4 year OS around 36%. Since the use of G-CSF in conjunction with fludarabine/cytarabine didn't improve the overall survival of patient in a randomized trial, only fludarabine and cytarabine will be used in this study to decrease the incidence of leukocytosis related complications. This regimen is very similar to the chemotherapy regimen proposed for the next relapsed AML trial within the Children's Oncology Group (COG). If this trial proves to be safe and active, it will provide the foundation and smooth transition to larger statistically powered nationwide phase II clinical trials by COG.

A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients)

CR is defined as a bone marrow with \< 5% blast by morphology, no evidence of extramedullary disease, and recovery of peripheral counts (ANC ≥ 1000/μl and platelet counts ≥ 100,000/μl). CR with incomplete count recovery (CRi) was defined as CR without recovery of ANC and/or platelets. Partial response (PR) was defined as complete disappearance of circulating blasts and a decrease of at least 50% of blasts in the bone marrow. Progressive disease (PD) was defined as an increase of at least 25% in the absolute number of bone marrow or circulating blasts, development of new sites of extramedullary disease, or other laboratory or clinical evidence of progression of disease. Stable disease (SD) referred to patient who did not satisfy the criteria for either CR, CRi, PR or PD.

Gateway for Cancer Research

The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.

Any patients in the AML arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.

AML Cohort: 75 mg/m2/Day

Any patients in the ALL arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.

ALL Cohort: 75 mg/m2/Day

This arm is comprised of the AML and ALL participants that completed Dose Level 1 75 mg/m2/day

Dose Level 1 75 mg/m2/Day

Age, Continuous

CNS Negative (better outcome): absence of blasts on a cytospin preparation in cerebral spinal fluid (CSF) or clinical signs of CNS leukemia

CNS Positive (worse outcome): presence of any number of blasts on a cytospin preparation in CSF or clinical signs of CNS leukemia

Central Nervous System (CNS) Status

Measurement of bone marrow response

M2 (better outcome): Marrow has between 5% and 25% leukemic blasts M3 (worse outcome): Marrow has more than 25% leukemic blasts

Bone Marrow Status (at study entry)

# Prior treatment regimens

Prior Hematopoetic Stem Cell Transplantation (HSCT)

White blood cell (WBC) Count

Peripheral blasts

Bone marrow blasts

Number that completed therapy and were analyzed

Roy Leong, BA, CCRP

# of patients with DLT

# of patients without DLT

# of patients not evaluable

Evaluable Participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)

Dose 75 mg/m2/Day Azacytidine Diagnosed With AML

Evaluable ALL participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)

Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

Participants with Acute Myeloid Leukemia (AML) who are evaluable for response.

A patient will be considered evaluable for response if: (1) the patient is eligible; (2) the patient receives all or part of protocol therapy; and (3) the patient is under follow-up for a sufficient period to evaluate the disease at the end of the course 2 or meets the definition of progressive disease. A patient who dies as a result of toxicity after receiving all or part of protocol therapy will be considered a non-responder.

Intervention:

* Azacytidine (Dose Level 1 @ 75 mg/m\^2/day)
* Fludarabine 30 mg/m\^2/dose
* Cytarabine 2000 mg/m\^2/dose
* Intrathecal (IT) Cytarabine

Dose 75 mg/m2/Day for AML Patients

Participants with Acute Lymphoblastic Leukemia (ALL) who are evaluable for response.

A patient will be considered evaluable for response if: (1) the patient is eligible; (2) the patient receives all or part of protocol therapy; and (3) the patient is under follow-up for a sufficient period to evaluate the disease at the end of the course 2 or meets the definition of progressive disease. A patient who dies as a result of toxicity after receiving all or part of protocol therapy will be considered a non-responder.

Intervention:

* Azacytidine (Dose Level 1 @ 75 mg/m\^2/day)
* Fludarabine 30 mg/m\^2/dose
* Cytarabine 2000 mg/m\^2/dose
* Intrathecal (IT) Methotrexate

Dose 75 mg/m2/Dose Azacytidine for ALL Patients

Disease Response Rate After Treatment

* Azacytidine (Dose Level @ 75 mg/m2/day),all patients will start at Dose Level 1. If 2 DLTs are observed within the first 6 patients enrolled, dose will be reduced to Dose Level 0 @ 50 mg/m2/day
* Fludarabine 30 mg/m2/dose
* Cytarabine 2000 mg/m2/dose
* Intrathecal (IT) Cytarabine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia	NCT01158885	Minimal Residua... Leukemia, Lymph... Leukemia, Myelo...	Clofarabine Cytarabine intr... Methotrexate Intrathecal (IT...	1 Year - 21 Years	Therapeutic Advances in Childhood Leukemia Consortium
Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia	NCT02680951	Acute Myeloid L...	Dasatinib Fludarabine Cytarabine Idarubicin Intrathecal (IT...	1 Year - 21 Years	Emory University
A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML	NCT01861002	Lymphoblastic L... Myelogenous Leu...	Azacytidine Fludarabine Cytarabine Intrathecal (IT... Intrathecal Met...	1 Year - 21 Years	Therapeutic Advances in Childhood Leukemia Consortium

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