Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01256398
First received: December 7, 2010
Last updated: September 12, 2016
Last verified: July 2016
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Purpose
This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 Untreated Adult Acute Lymphoblastic Leukemia |
Biological: Alemtuzumab Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Procedure: Autologous Hematopoietic Stem Cell Transplantation Drug: Cyclophosphamide Drug: Cytarabine Drug: Dasatinib Drug: Daunorubicin Hydrochloride Drug: Dexamethasone Drug: Etoposide Phosphate Biological: Filgrastim Drug: Fludarabine Phosphate Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Drug: Melphalan Drug: Mercaptopurine Drug: Methotrexate Biological: Pegfilgrastim Other: Pharmacological Study Drug: Tacrolimus Drug: Vincristine Sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Mechlorethamine
Mechlorethamine hydrochloride
Methotrexate
Folic acid
Phenylalanine
Cytarabine
Melphalan
Calcium Gluconate
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Melphalan hydrochloride
Sulfate ion
Methotrexate sodium
Daunorubicin
Fludarabine
Daunorubicin hydrochloride
Etoposide
Dexamethasone acetate
Levoleucovorin
Fludarabine phosphate
Tacrolimus
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Pegfilgrastim
Alemtuzumab
Dasatinib
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- DFS defined from the date of first induction complete response (CR) to relapse or death due to any cause [ Time Frame: At 3 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
Secondary Outcome Measures:
- DFS [ Time Frame: From the date of first induction CR to relapse, or death due to any cause, with patients last known to be alive and disease-free censored at the date of last contact, assessed up to 10 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
- Feasibility of maintenance therapy in this patient population (restricted to those patients achieving a CR) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Proportions will be estimated based on the combined and individual cohorts.
- OS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
- Probability of being BCR-ABL negative in the bone marrow and peripheral blood at the completion of the CNS prophylaxis course (restricted to those patients achieving a CR) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Proportions will be estimated based on the combined and individual cohorts.
- Response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (chemotherapy, transplant)
See Detailed Description
|
Biological: Alemtuzumab
Given IV
Other Names:
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo peripheral blood allogeneic HCT
Other Names:
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo peripheral blood autologous HCT
Other Name: Autologous Stem Cell Transplantation
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine
Given IV
Other Names:
Drug: Dasatinib
Given PO
Other Names:
Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
Drug: Dexamethasone
Given PO or IV
Other Names:
Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos
Biological: Filgrastim
Given SC
Other Names:
Drug: Fludarabine Phosphate
Given IV
Other Names:
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Undergo peripheral blood autologous or allogeneic HCT
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Leucovorin Calcium
Given IV or PO
Other Names:
Drug: Melphalan
Given IV
Other Names:
Drug: Mercaptopurine
Given PO
Other Names:
Drug: Methotrexate
Given IT, IV, or PO
Other Names:
Biological: Pegfilgrastim
Given SC
Other Names:
Other: Pharmacological Study
Correlative studies
Drug: Tacrolimus
Given IV or PO
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unequivocal histologic diagnosis of ALL
- Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive status by molecular analysis (Q-PCR or fluorescent in situ hybridization [FISH]) in a Cruise Lines International Association (CLIA)-approved laboratory
- No prior therapy except up to one week of corticosteroids and/or hydroxyurea to enable time for the detection of t(9;22)(q34;q11) or BCR/ABL
- Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
- Left ventricular ejection fraction >= lower limit of institutional normal
- No myocardial infarction within 6 months
- No ventricular tachyarrhythmia within 6 months
- No major conduction abnormality (unless a cardiac pacemaker is present)
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: NCT01256398
Show 102 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256398
Show 102 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Matthew Wieduwilt | Alliance for Clinical Trials in Oncology |
More Information
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01256398 History of Changes |
| Other Study ID Numbers: | NCI-2011-02621 NCI-2011-02621 CDR0000690286 CALGB 10701/CTSU C10701 CALGB-10701 CALGB-10701 U10CA180821 U10CA031946 |
| Study First Received: | December 7, 2010 |
| Last Updated: | September 12, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Fludarabine Alemtuzumab Fludarabine phosphate |
Etoposide phosphate Cyclophosphamide Methotrexate Etoposide Cytarabine Vincristine Dasatinib Melphalan 6-Mercaptopurine Daunorubicin Mechlorethamine Nitrogen Mustard Compounds Tacrolimus Antibodies Immunoglobulins |
ClinicalTrials.gov processed this record on September 23, 2016