Trial record 1 of 1 for:
aall1231
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
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| ClinicalTrials.gov Identifier: NCT02112916 |
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Recruitment Status :
Active, not recruiting
First Posted : April 14, 2014
Results First Posted : February 23, 2022
Last Update Posted : May 23, 2023
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Brief Summary:
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult T Acute Lymphoblastic Leukemia Ann Arbor Stage II Adult Lymphoblastic Lymphoma Ann Arbor Stage II Childhood Lymphoblastic Lymphoma Ann Arbor Stage III Adult Lymphoblastic Lymphoma Ann Arbor Stage III Childhood Lymphoblastic Lymphoma Ann Arbor Stage IV Adult Lymphoblastic Lymphoma Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma Childhood T Acute Lymphoblastic Leukemia | Drug: Bortezomib Drug: Cyclophosphamide Drug: Cytarabine Drug: Daunorubicin Drug: Daunorubicin Hydrochloride Drug: Dexamethasone Drug: Doxorubicin Drug: Doxorubicin Hydrochloride Drug: Etoposide Drug: Hydrocortisone Sodium Succinate Drug: Ifosfamide Drug: Leucovorin Calcium Drug: Mercaptopurine Drug: Methotrexate Drug: Pegaspargase Radiation: Radiation Therapy Drug: Thioguanine Drug: Vincristine Drug: Vincristine Sulfate | Phase 3 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 847 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy) |
| Actual Study Start Date : | September 30, 2014 |
| Actual Primary Completion Date : | March 31, 2020 |
| Estimated Study Completion Date : | September 22, 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Bortezomib
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm A (combination chemotherapy)
Patients receive combination chemotherapy without bortezomib. See Detailed Description.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Drug: Daunorubicin Given IV
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Drug: Hydrocortisone Sodium Succinate Given IT
Other Names:
Drug: Ifosfamide Given IV
Other Names:
Drug: Leucovorin Calcium Given PO or IV
Other Names:
Drug: Mercaptopurine Give PO
Other Names:
Drug: Methotrexate Given IT, IV, or PO
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm B (combination chemotherapy, bortezomib)
Patients receive combination chemotherapy with bortezomib (4 doses at 1.3 mg/m^2 during Induction and 4 doses at 1.3 mg/m^2 during Delayed Intensification). See Detailed Description.
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Drug: Bortezomib
Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Drug: Daunorubicin Given IV
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Drug: Hydrocortisone Sodium Succinate Given IT
Other Names:
Drug: Ifosfamide Given IV
Other Names:
Drug: Leucovorin Calcium Given PO or IV
Other Names:
Drug: Mercaptopurine Give PO
Other Names:
Drug: Methotrexate Given IT, IV, or PO
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Primary Outcome Measures :
- Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients [ Time Frame: 3 years ]EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups.
Secondary Outcome Measures :
- Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase [ Time Frame: 3 years from start of therapy by patient ]Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
- EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) [ Time Frame: 3 years ]EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact.
- Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) [ Time Frame: 3 years ]Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988
- EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 [ Time Frame: 3 years ]EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact.
- EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond [ Time Frame: 3 years ]EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond
Information from the National Library of Medicine
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| Ages Eligible for Study: | 1 Year to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
- All patients must be > 1 and < 31 years of age
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Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV
- Note: a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or > 25% in the bone marrow; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including terminal deoxynucleotidyl transferase (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory
- For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be accepted
- All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
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Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:
- Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility
- Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or
- Pretreatment with hydroxyurea; or
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600 cGy of chest irradiation, if medically necessary
- Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment
- Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
- Uncontrolled seizure disorder
- Diagnosis of Down syndrome (Trisomy 21)
- Patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
- Lactating females who plan to breastfeed
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
- Patient has hypersensitivity to bortezomib, boron, or mannitol
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112916
Locations
Show 212 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | David T Teachey | Children's Oncology Group |
Study Documents (Full-Text)
Documents provided by National Cancer Institute (NCI):
Documents provided by National Cancer Institute (NCI):
Study Protocol and Statistical Analysis Plan [PDF] May 29, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT02112916 |
| Other Study ID Numbers: |
NCI-2014-00712 NCI-2014-00712 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) s14-01925 AALL1231 ( Other Identifier: Children's Oncology Group ) AALL1231 ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 14, 2014 Key Record Dates |
| Results First Posted: | February 23, 2022 |
| Last Update Posted: | May 23, 2023 |
| Last Verified: | March 2023 |
Additional relevant MeSH terms:
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Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Calcium, Dietary Leucovorin Folic Acid |
Cytarabine Dexamethasone Dexamethasone acetate Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Cyclophosphamide Ifosfamide Isophosphamide mustard Doxorubicin Liposomal doxorubicin Methotrexate Etoposide Vincristine |