Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Philadelphia Chromosome

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity

Bristol-Myers Squibb

The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment.

Events for EFS are defined as ANY first one of the following:

* Lack of complete response in bone marrow
* Relapse at any site
* Development of second malignant neoplasm
* Death from any cause

Number of participants experiencing different types of all causality all grade adverse events

Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.

Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. \< 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.

MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%

A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.

Children's Oncology Group

EsPhALL

Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.

Dasatinib Cohort

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control

Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control

3-year Event-free Survival (EFS) Rate

Adverse Events (AEs)

Drug-related AEs

AEs leading to discontinuation

Serious Adverse Events (SAEs)

Deaths

Number of Participants Experiencing Adverse Events

3-year EFS Estimate

5-year EFS Estimate

Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)

End of Induction period Ia

End of Induction period Ib

End of Consolidation period

Complete Remission Rate

Percentage of Participants Negative for Minimal Residual Disease (MRD)

At Baseline

At Disease Progression or Relapse

All treated participants with available measurements

Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse

Treatment Phase

Follow-up Phase

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Imatinib Mesylate

Dasatinib 60 mg/m² tablet every day (QD) \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Dasatinib 80 mg/m² tablet QD \[with a maximum dose of 140 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 96 mg/m² PFOS QD \[with a maximum dose of 170 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Dasatinib 60 mg/m² tablet QD \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² PFOS QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.

Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.

Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.

Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.

Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.

The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on \>=20 Metaphases)

Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on \>=20 Metaphases)

Duration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases)

Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on \>=20 Metaphases)

Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases)

PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to \>20.0x10\^9/L; Platelet count rises to \>600x10\^9/L; appearance of extramedullary disease; appearance of \>5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by \>=30% from nadir -Death from any case during treatment

Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.

Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.

Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)

OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.

Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL \<= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to \< 0.1% or a 3-log reduction from baseline was considered an MMR.

Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.

Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.

Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL \<= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to \< 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.

Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.

Cohort 3a

Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.

Cohort 3b

Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.

Cohort 1

Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.

Cohort 2: BP-CML Only

Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.

Cohort 2: Ph+ ALL Only

Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.

Cohort 2

Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.

Cohort 3

Total

< 2 years

>= 2 to < 7 years

>= 7 to < 12 years

>= 12 to < 18 years

>= 18 years

Age, Customized

White

Black or African American

Asian

American Indian or Alaska Native

Other

Race/Ethnicity, Customized

Primary efficacy endpoint pre-specified only for participants treated in Cohort 1

Major Cytogenetic Response (MCyR) Rate

Primary efficacy endpoint pre-specified only for participants treated in Cohort 2

Complete Hematologic Response (CHR) Rate

Primary efficacy endpoint pre-specified only for participants treated in Cohort 3

Complete Cytogenetic Response (CCyR) Rate

Secondary efficacy endpoint pre-specified only for participants treated in Cohort 2

Major Cytogenetic Response (MCyR) Rate in Cohort 2

Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3

Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3

Complete (0%)

Partial (>0% - 35%)

Minor (>35% - 65%)

Minimal (>65% - 95%)

No Response (>95% - 100%)

Unable to Determine

Rate of Best Cytogenetic Response

Time to Major Cytogenetic Response (MCyR)

Duration of Major Cytogenetic Response (MCyR)

Time to Complete Cytogenetic Response (CCyR)

All treated participants who achieved CCyR

Duration of Complete Cytogenetic Response (CCyR)

Progression-Free Survival (PFS) Rate at 2 Years

Time to Complete Hematologic Response (CHR)

Duration of Complete Hemotologic Response (CHR)

All randomized treated participants with response of CCyR or CHR

Disease-Free Survival Rate at 2 Years

Overall Survival (OS) Rate at 2 Years

Major Molecular Response (MMR) Rate

Complete Molecular Response (CMR) Rate

12 months

24 months

Major Cytogenetic Response (MCyR) Rate up to 2 Years

Complete Cytogenetic Response (CCyR) Rate up to 2 Years

Major Molecular Response (MMR) Rate up to 2 Years

Complete Molecular Response (CMR) Rate up to 2 Years

On Treatment

Follow-Up

Neoplastic Processes

Nilotinib

Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.

Resistant or Intolerant to either imatinib or dasatinib

Resistant or intolerant to either imatinib or dasatinib - at the end no patients were enrolled in this arm.

Nilotinib supplied in 50mg, 150mg, and 200mg capsules. It was administered orally at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Dose administration was rounded to the nearest 50mg dose (to a maximum dose of 400mg).

nilotinib

Novartis Pharmaceuticals

To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).

The study was designed as a multi-center, open-label, non-controlled phase II study to assess efficacy, safety and PK parameters of 230 mg/m2 twice daily nilotinib in pediatric patients (1 to \<18 years old). The study population consisted of three cohorts of Ph+ CML pediatric patients:

* Cohort 1: Ph+ CML-CP patients resistant or intolerant to either imatinib or dasatinib
* Cohort 2: Ph+ CML-AP patients resistant or intolerant to either imatinib or dasatinib
* Cohort 3: Newly-diagnosed Ph+ CML-CP patients in first chronic phase A minimum number of 50 pediatric patients (from 1 to \<18 years) were enrolled in the study. Of them, at least 15 patients were Ph+ CML-CP patients resistant or intolerant to either imatinib or dasatinib, and at least 15 were newly-diagnosed Ph+ CML-CP patients in first chronic phase patients. There was no minimum number of patients required for Ph+ CML-AP patients resistant or intolerant to either imatinib or dasatinib.

Based on enrollment forecasts as of Jan 2015, and to reflect the agreements with the US FDA and the PDCO, the study remained open for enrollment until the targeted number of 50 patients with at least 15 newly diagnosed Ph+CML patients was achieved or until 31May2015, whichever was later.

Patients who completed the study were treated with nilotinib for a total of 66 cycles of 28 days unless the patient prematurely discontinued study treatment.

The primary analysis cut-off date was the date when all patients enrolled in the trial either completed their visit for treatment cycle 12 or had discontinued study treatment early (EoT/early discontinuation visit). These analyses were reported in the 12-cycle clinical study report (CSR). A 24-cycle analysis was done when all patients had either completed their 24-cycle treatment visit or had discontinued study treatment early.

At trial end, a final comprehensive CSR of all data collected during the trial was produced.

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

The summary of bone age and Dual-energy X-ray absorptiometry (DEXA) by cohort. Alteration of bone biochemical markers of hand and wrist X-Ray evaluation was observed in bone age standard deviation scores (SDS) and for bone mineral density for DEXA before and after treatment with nilotinib.

MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR at 6 cycles if the patient met the MMR criteria at the Cycle 6 Visit.

MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by 12 cycles if the patient met the MMR criteria at least once at any time between first study drug intake and Cycle 12 visit included.

Cytogenetic response is assessed as the percentage of Philadelphia positive (Ph+) metaphases in the bone marrow. Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as CCyR at 12 cycles if the patient met the CCyR criteria at the Cycle 12 Visit.

Major molecular response (MMR) was defined as BCR-ABL/ABL % ≤ 0.1% by IS as measured by RQ-PCR, confirmed by duplicate analysis of the same sample.

MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: \> 0.0032 to ≤ 0.01% is equal to a log reduction category of \>= 4 to \<4.5 -log reduction (MR4); BCR-ABL ratio by percentage: \<=0.0032% is equal to a log reduction category of \>= 4.5-log reduction (MMR4.5)

Time from first study drug intake to first MMR amongst imatinib or dasatinib resistant or intolerant patients with CML-CP computed only for patients who achieved MMR.

Time to MMR is the time from first study drug intake to first major molecular response computed only for participants who achieved MMR.

Duration of MMR is defined as the time between the date of the first MMR and the date of confirmed loss of MMR (i.e. the earliest of confirmed loss of MMR, CML-related death or progression to AP or BC). Participants without loss of MMR were censored at the last molecular assessment date.

* Complete cytogenetic response (CCyR) - 0% Ph+ metaphases
* Partial cytogenetic response (PCyR) - \>0 to 35% Ph+ metaphases
* Minor cytogenetic response (mCyR) - \>35 to 65% Ph+ metaphases
* Minimal - \>65 to 95% Ph+ metaphases
* None - \>95 to 100% Ph+ metaphases
* Major cytogenetic response (MCyR) - 0 to 35% Ph+ metaphases. A major response combines both complete and partial responses.

Complete cytogenetic response (CCyR) - 0% Ph+ metaphases No response - \>95 to 100% Ph+ metaphases

Cytogenetic response is assessed as the percentage of Philadelphia positive (Ph+) metaphases in the bone marrow. Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as having CCyR by 6 cycles (respectively 12 cycles) if the patient met the CCyR criteria at least once at any time between first study drug intake and cycle 6 (cycle 12 respectively) visit included.

Major cytogenetic response (MCyR) - 0 to 35% Ph+ metaphases. A major response combines both complete and partial responses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia	NCT01460160	Leukemia, Pedia...	Dasatinib	1 Year - 17 Years	Bristol-Myers Squibb
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib	NCT00777036	Leukemia	Dasatinib	1 Day - 18 Years	Bristol-Myers Squibb
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.	NCT01844765	Philadelphia Po...	nilotinib	1 Year - 17 Years	Novartis
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib	NCT00777036	Leukemia	Dasatinib	1 Day - 18 Years	Bristol-Myers Squibb

Spots Global Cancer Trial Database for leukemia, pediatric