- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00501826
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the complete remission (CR) rate and progression-free survival following treatment with hyperfractionated cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (hyper-CVAD) in combination with nelarabine in previously untreated patients with T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic lymphoma.
II. To determine the safety and overall survival of previously untreated patients with T-cell ALL and T-cell lymphoblastic lymphoma.
III. To determine the safety and efficacy of adding pegaspargase to the regimen.
IV. To determine the safety and efficacy of adding venetoclax to the regimen.
OUTLINE:
COURSES 1, 3, 5, and 7 (hyper-CVAD): Patients receive cyclophosphamide intravenously (IV) over 3 hours twice daily (BID) on day 1-3, doxorubicin IV over 24 hours on day 4, vincristine IV over 15-30 minutes on days 4 and 11, and dexamethasone IV or orally (PO) once daily (QD) on days 1-4 and 11-14.
COURSES 2, 4, 6, and 8 (methotrexate/cytarabine): Patients receive methotrexate IV over 24 hours on day 1 and cytarabine IV over 2 hours BID on days 2 and 3.
Patients also receive venetoclax PO QD on days 1-14 of each course. Courses of hyper-CVAD and methotrexate/cytarabine repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also receive nelarabine IV over 2 hours once daily (QD) for 5 days and pegaspargase IV over 2 hours on day 5 after completion of course 4 and after the completion of course 5 in the absence of disease progression or unacceptable toxicity.
MAINTENANCE COURSES 1-5, 8-17, and 20-30 (mercaptopurine, vincristine, methotrexate, and prednisone [POMP]): Patients receive mercaptopurine PO thrice daily (TID), methotrexate PO once weekly, vincristine sulfate IV on day 1, prednisone PO QD on days 1-5, and venetoclax PO QD on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
INTENSIFICATION COURSES 6 and 7: Patients receive nelarabine IV QD over 2 hours on days 1-5 and pegaspargase IV over 2 hours on day 5. Patients also receive venetoclax PO QD on days 1-14. Courses repeat every 21-35 days in the absence of disease progression or unacceptable toxicity.
INTENSIFICATION COURSES 18 and 19: Patients receive methotrexate IV over 2 hours on day 1, pegaspargase IV over 2 hours on day 2, and venetoclax PO QD on days 1-14 in the absence of disease progression or unacceptable toxicity.
POMP maintenance therapy continues for 30 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Farhad Ravandi-Kashani, MD
- Phone Number: 713-745-0394
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Farhad Ravandi-Kashani
- Phone Number: 713-745-0394
-
Principal Investigator:
- Farhad Ravandi-Kashani
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =< 2 courses are also eligible
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3
- Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN)
- Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable
Exclusion Criteria:
- Pregnant or nursing women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (nelarabine and combination chemotherapy)
See Detailed Description
|
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV or PO
Other Names:
Given IV and PO
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission rate
Time Frame: 3 years
|
The sample size will provide an estimate of relapse rate at 3 years with a 95% confidence interval of width +/- 10%.
|
3 years
|
Duration of remission
Time Frame: Up to 9 years
|
Duration of remission will be evaluated.
|
Up to 9 years
|
Progression-free survival
Time Frame: 3 years
|
Progression-free survival will be estimated.
|
3 years
|
Overall survival
Time Frame: 3 years
|
Overall survival will be estimated.
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Farhad Ravandi-Kashani, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Lymphoma
- Leukemia
- Lymphoma, Non-Hodgkin
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Cyclophosphamide
- Venetoclax
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Cytarabine
- Methotrexate
- Vincristine
- Asparaginase
- Mercaptopurine
- Cortisone
- Pegaspargase
- 6-methoxypurine arabinoside
Other Study ID Numbers
- 2006-0328 (Other Identifier: M D Anderson Cancer Center)
- NCI-2012-01518 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on T Acute Lymphoblastic Leukemia
-
National Cancer Institute (NCI)Active, not recruitingAcute Lymphoblastic Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Adult T Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | Adult L1 Acute Lymphoblastic Leukemia | Adult L2 Acute Lymphoblastic...United States
-
Fundamenta Therapeutics, Ltd.The First Affiliated Hospital of University of Science and Technology of...RecruitingT-Acute Lymphoblastic Leukemia | T-cell Non-Hodgkin Lymphoma | T-cell Acute Lymphoblastic LymphomaChina
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI)RecruitingRefractory T Acute Lymphoblastic Leukemia | Recurrent T Acute Lymphoblastic LeukemiaUnited States
-
Gruppo Italiano Malattie EMatologiche dell'AdultoRecruitingT-lymphoblastic Lymphoma | T Acute Lymphoblastic Leukemia | Early T Acute Lymphoblastic Leukemia | Etp AllItaly
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Refractory T Acute Lymphoblastic Leukemia | Recurrent T Acute Lymphoblastic LeukemiaUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); The Leukemia...TerminatedT-Acute Lymphoblastic Leukemia | Adult T Lymphoblastic LymphomaUnited States
-
Beijing GoBroad HospitalNot yet recruitingAcute Lymphoblastic Leukemia, in Relapse | Refractory Acute Lymphoblastic Leukemia | T-Cell Acute Lymphocytic Leukemia
-
Children's Oncology GroupNational Cancer Institute (NCI); ImmunoGen, Inc.WithdrawnRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Recurrent Mixed Phenotype Acute Leukemia | Refractory Mixed Phenotype Acute Leukemia | Refractory T Acute Lymphoblastic Leukemia | Recurrent...
-
Therapeutic Advances in Childhood Leukemia ConsortiumGlaxoSmithKline; NovartisTerminatedRelapsed T-Cell Acute Lymphoblastic Leukemia | Relapsed T-Cell Lymphoblastic LymphomaUnited States, France, Canada, Australia, Austria, Italy, Netherlands
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingAcute Lymphoblastic Leukemia | Acute Undifferentiated Leukemia | Childhood T Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand
Clinical Trials on Cytarabine
-
Sunesis PharmaceuticalsCompletedAcute Myeloid LeukemiaUnited States, Canada, Spain, Belgium, Korea, Republic of, Australia, France, Germany, Poland, New Zealand, United Kingdom, Czechia, Austria, Hungary, Italy
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Chronic Myelomonocytic Leukemia | Refractory Chronic Myelomonocytic Leukemia | Blasts More Than 5 Percent of Bone Marrow Nucleated Cells | Recurrent High Risk Myelodysplastic Syndrome | Refractory High Risk Myelodysplastic Syndrome | Blasts 10-19 Percent of Bone Marrow Nucleated Cells and other conditionsUnited States
-
Jianxiang WangUnknownAcute Myeloid LeukemiaChina
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)RecruitingRefractory Acute Myeloid Leukemia | Blasts More Than 5 Percent of Bone Marrow Nucleated Cells | Persistent DiseaseUnited States
-
M.D. Anderson Cancer CenterRecruitingRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAcute Myeloid Leukemia | Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Secondary Acute Myeloid LeukemiaUnited States
-
Roswell Park Cancer InstituteJazz PharmaceuticalsRecruitingAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Secondary Acute Myeloid Leukemia | Therapy-Related Acute Myeloid Leukemia | Acute Myeloid Leukemia With Myelodysplasia-Related ChangesUnited States
-
M.D. Anderson Cancer CenterRecruitingMyelodysplastic Syndrome | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Myeloproliferative Neoplasm | Acute Myeloid Leukemia With Gene MutationsUnited States
-
Institute of Hematology & Blood Diseases Hospital...Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Recurrent Myelodysplastic Syndrome | Refractory Acute Myeloid Leukemia | Refractory Myelodysplastic Syndrome | High Risk Myelodysplastic Syndrome | Blasts More Than 10 Percent of Bone Marrow Nucleated CellsUnited States