A Phase 2 interventional study of aminopterin and L-asparaginase in Acute Lymphocytic Leukemia, sponsored by Rutgers, The State University of New Jersey. Completed at 2 sites in United States. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.
Outline of Therapy:
Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years.
Therapy will be divided into five phases:
Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow).
Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse.
Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times.
Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks.
Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis.
Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 60 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
Drug: L-asparaginase · Drug: daunomycin · Drug: dexamethasone · Drug: 6-mercaptopurine · Drug: methotrexate · Drug: vincristine · Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone) · Drug: Leucovorin
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
Drug: aminopterin · Drug: L-asparaginase · Drug: cyclophosphamide · Drug: cytarabine · Drug: daunomycin · Drug: dexamethasone · Drug: 6-mercaptopurine · Drug: 6-thioguanine · Drug: vincristine · Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone) · Drug: Leucovorin
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years
This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
Time frame: 5 years
To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis
Time frame: 5 years
59 patients with ALL were enrolled between March, 2001 and September, 2005 at the Cancer Institute of New Jersey (outpatient clinical research facility) and 1 patient was enrolled at Jersey Shore University Medical Center (a community hospital).
| Milestone | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| Started | 21 | 39 |
| Completed | 20 | 34 |
| Not completed | 1 | 5 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Milestone | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| Started | 20 | 34 |
| Completed | 20 | 29 |
| Not completed | 0 | 5 |
| Withdrew: Patient moved to another state | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Not documented | 0 | 1 |
| Milestone | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| Started | 20 | 29 |
| Completed | 20 | 29 |
| Not completed | 0 | 0 |
| Milestone | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| Started | 20 | 29 |
| Completed | 19 | 26 |
| Not completed | 1 | 3 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 3 |
| Milestone | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| Started | 19 | 26 |
| Completed | 19 | 26 |
| Not completed | 0 | 0 |
This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
| percentage of participants | Arm 2 High Risk |
|---|---|
| Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years | 64.9 |
No measurements were reported for this outcome.
Collected over 7 years, 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 Standard Risk | — | 20/21 (95.2%) | 21/21 (100%) |
| Arm 2 High Risk | — | 36/39 (92.3%) | 39/39 (100%) |
| Event | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| Febrile neutropeniaInfections and infestations | 16/21 | 17/39 |
| PlateletsBlood and lymphatic system disorders | 5/21 | 5/39 |
| Infection without neutropeniaInfections and infestations | 3/21 | 1/39 |
| Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 3/21 | 2/39 |
| Muscle weakness (not due to neuropathy)Musculoskeletal and connective tissue disorders | 0/21 | 5/39 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/21 | 1/39 |
| Infection with unknown ANCInfections and infestations | 1/21 | 3/39 |
| DehydrationGastrointestinal disorders | 0/21 | 3/39 |
| AnorexiaGeneral disorders | 0/21 | 3/39 |
| HemoglobinBlood and lymphatic system disorders | 1/21 | 3/39 |
| Event | Arm 1 Standard Risk | Arm 2 High Risk |
|---|---|---|
| FeverGeneral disorders | 12/21 | 15/39 |
| VomitingGastrointestinal disorders | 2/21 | 7/39 |
| Headache - Pain-HeadGeneral disorders | 0/21 | 7/39 |
| Allergic reaction/hypersensitivityImmune system disorders | 3/21 | 0/39 |
| Other ToxicityGeneral disorders | 3/21 | 5/39 |
| DehydrationGastrointestinal disorders | 1/21 | 5/39 |
| Infection with unknown ANCInfections and infestations | 1/21 | 4/39 |
| Abdominal pain or crampingGastrointestinal disorders | 1/21 | 4/39 |
| Stomatitis / pharyngitisGastrointestinal disorders | 1/21 | 4/39 |
| HemoglobinBlood and lymphatic system disorders | 2/21 | 0/39 |
| Age, Categorical(Participants) | Arm 1 Standard Risk | Arm 2 High Risk | Total |
|---|---|---|---|
| <=18 years | 21 | 30 | 51 |
| Between 18 and 65 years | 0 | 9 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm 1 Standard Risk | Arm 2 High Risk | Total |
|---|---|---|---|
| Mean | 3.71 ± 1.77 | 16 ± 9.8 | 11.7 ± 9.89 |
| Sex: Female, Male(Participants) | Arm 1 Standard Risk | Arm 2 High Risk | Total |
|---|---|---|---|
| Female | 11 | 18 | 29 |
| Male | 10 | 21 | 31 |
| Region of Enrollment(participants) | Arm 1 Standard Risk | Arm 2 High Risk | Total |
|---|---|---|---|
| United States | 21 | 39 | 60 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey