Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Talazoparib
- drug: Topotecan
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute
undifferentiated leukemia or mixed phenotype acute leukemia), specified as either
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or
relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics
Inc.
2. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic
blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of
the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to
diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
3. Rising MRD > 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by
Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if
there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral
blood
3. > 60 days has passed since hematopoietic stem cell transplant.
4. Patients who have undergone previous allogeneic stem cell transplantation who are
otherwise eligible must also be without evidence of any active graft versus host
disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior
to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg)
or equivalent other steroid dose is allowable.
5. A minimum of 14 days has passed since completion of myelosuppressive therapy or
gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or
non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100
mg/m2).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects > 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea
or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria:
1. Patients receiving or planning to receive ANY concurrent cancer therapy, including
chemotherapy, radiation therapy, immunotherapy or biologic therapy.
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia
(JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed
consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Brodsky
(650)721-4087
I'm interested
Psoriasis Clinical Trials
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Talazoparib
- drug: Topotecan
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute
undifferentiated leukemia or mixed phenotype acute leukemia), specified as either
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or
relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics
Inc.
2. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic
blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of
the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to
diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
3. Rising MRD > 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by
Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if
there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral
blood
3. > 60 days has passed since hematopoietic stem cell transplant.
4. Patients who have undergone previous allogeneic stem cell transplantation who are
otherwise eligible must also be without evidence of any active graft versus host
disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior
to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg)
or equivalent other steroid dose is allowable.
5. A minimum of 14 days has passed since completion of myelosuppressive therapy or
gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or
non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100
mg/m2).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects > 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea
or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria:
1. Patients receiving or planning to receive ANY concurrent cancer therapy, including
chemotherapy, radiation therapy, immunotherapy or biologic therapy.
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia
(JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed
consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Brodsky
(650)721-4087
I'm interested
Dermatology Clinical Trials
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Talazoparib
- drug: Topotecan
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute
undifferentiated leukemia or mixed phenotype acute leukemia), specified as either
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or
relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics
Inc.
2. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic
blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of
the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to
diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
3. Rising MRD > 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by
Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if
there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral
blood
3. > 60 days has passed since hematopoietic stem cell transplant.
4. Patients who have undergone previous allogeneic stem cell transplantation who are
otherwise eligible must also be without evidence of any active graft versus host
disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior
to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg)
or equivalent other steroid dose is allowable.
5. A minimum of 14 days has passed since completion of myelosuppressive therapy or
gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or
non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100
mg/m2).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects > 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea
or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria:
1. Patients receiving or planning to receive ANY concurrent cancer therapy, including
chemotherapy, radiation therapy, immunotherapy or biologic therapy.
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia
(JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed
consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Brodsky
(650)721-4087
I'm interested
Pediatric Dermatology Clinical Trials
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Talazoparib
- drug: Topotecan
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute
undifferentiated leukemia or mixed phenotype acute leukemia), specified as either
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or
relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics
Inc.
2. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic
blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of
the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to
diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
3. Rising MRD > 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by
Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if
there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral
blood
3. > 60 days has passed since hematopoietic stem cell transplant.
4. Patients who have undergone previous allogeneic stem cell transplantation who are
otherwise eligible must also be without evidence of any active graft versus host
disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior
to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg)
or equivalent other steroid dose is allowable.
5. A minimum of 14 days has passed since completion of myelosuppressive therapy or
gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or
non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100
mg/m2).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects > 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea
or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria:
1. Patients receiving or planning to receive ANY concurrent cancer therapy, including
chemotherapy, radiation therapy, immunotherapy or biologic therapy.
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia
(JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed
consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Brodsky
(650)721-4087
I'm interested
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Talazoparib
- drug: Topotecan
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute
undifferentiated leukemia or mixed phenotype acute leukemia), specified as either
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or
relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics
Inc.
2. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic
blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of
the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to
diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
3. Rising MRD > 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by
Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if
there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral
blood
3. > 60 days has passed since hematopoietic stem cell transplant.
4. Patients who have undergone previous allogeneic stem cell transplantation who are
otherwise eligible must also be without evidence of any active graft versus host
disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior
to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg)
or equivalent other steroid dose is allowable.
5. A minimum of 14 days has passed since completion of myelosuppressive therapy or
gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or
non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100
mg/m2).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects > 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea
or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria:
1. Patients receiving or planning to receive ANY concurrent cancer therapy, including
chemotherapy, radiation therapy, immunotherapy or biologic therapy.
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia
(JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed
consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Brodsky
(650)721-4087
I'm interested
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Talazoparib
- drug: Topotecan
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute
undifferentiated leukemia or mixed phenotype acute leukemia), specified as either
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or
relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics
Inc.
2. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic
blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of
the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to
diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
3. Rising MRD > 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by
Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if
there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral
blood
3. > 60 days has passed since hematopoietic stem cell transplant.
4. Patients who have undergone previous allogeneic stem cell transplantation who are
otherwise eligible must also be without evidence of any active graft versus host
disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior
to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg)
or equivalent other steroid dose is allowable.
5. A minimum of 14 days has passed since completion of myelosuppressive therapy or
gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or
non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100
mg/m2).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects > 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea
or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria:
1. Patients receiving or planning to receive ANY concurrent cancer therapy, including
chemotherapy, radiation therapy, immunotherapy or biologic therapy.
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia
(JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed
consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Brodsky
(650)721-4087
I'm interested