Acute Lymphocytic LeukemiaPhase 2NCT00176462

CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

A Phase 2 study testing aminopterin, L-asparaginase and cyclophosphamide in people with Acute Lymphocytic Leukemia, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 1 year to 30 years
Conditions the study is for: Acute Lymphocytic Leukemia
What is being tested?: aminopterin, L-asparaginase and cyclophosphamide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: Feb 2001to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 30 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)
Patients with overt CNS (central nervous system) or testicular disease are eligible
Informed consent according to institutional and FDA guidelines.
Adequate organ function is required.
HIV seropositive patients will not be excluded from this study.
Patients greater than 1 year of age and less than 29.99 years of age are eligible.

Who cannot join

Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible.
All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction <40%, total bilirubin >2, serum creatinine >2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin >2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Acute Lymphocytic Leukemia
Being tested: aminopterin, L-asparaginase, cyclophosphamide, cytarabine, daunomycin
Keywords: Acute Lymphocytic Leukemia, Leukemia
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aminopterinDrug
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
L-asparaginaseDrug
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
cyclophosphamideDrug
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
cytarabineDrug
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
daunomycinDrug
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
dexamethasoneDrug
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
6-mercaptopurineDrug
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
methotrexateDrug
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
6-thioguanineDrug
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
vincristineDrug
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
Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)Drug
LeucovorinDrug

Study groups in NCT00176462
Study group	Role	What they receive
Arm 1 Standard Risk	Experimental	6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin Receives: Drug: L-asparaginase; Drug: daunomycin; Drug: dexamethasone; Drug: 6-mercaptopurine; Drug: methotrexate; Drug: vincristine; Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone); Drug: Leucovorin
Arm 2 High Risk	Experimental	6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 years

Secondary outcomes (1)

To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2001Sep 2008

First posted15 Sep 2005 (estimated)
Study startFeb 2001
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00176462
Sponsor's protocol ID: 020101
Other IDs: 0220003389, P30CA072720
Status last verified: May 2014
First submitted: 12 Sep 2005
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Lymphocytic Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT00176462
Acronym / sponsor ID: 020101
Conditions: Acute Lymphocytic Leukemia
Keywords: Acute Lymphocytic Leukemia, Leukemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2001
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 9 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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:

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1 Standard Risk	Experimental	Drug: L-asparaginase, Drug: daunomycin, Drug: dexamethasone, Drug: 6-mercaptopurine, Drug: methotrexate, Drug: vincristine, Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone), Drug: Leucovorin6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
Arm 2 High Risk	Experimental	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: Leucovorin6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C

Who may qualify

Ages: 1 year to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)
Patients with overt CNS (central nervous system) or testicular disease are eligible
Informed consent according to institutional and FDA guidelines.
Adequate organ function is required.
HIV seropositive patients will not be excluded from this study.

Key exclusion criteria (2 listed)

Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible.
All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction <40%, total bilirubin >2, serum creatinine >2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin >2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aminopterinTherapy 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	Drug	Arm 2 High Risk
L-asparaginaseTherapy 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	Drug	Arm 1 Standard Risk, Arm 2 High Risk
cyclophosphamideTherapy 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	Drug	Arm 2 High Risk
cytarabineTherapy 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	Drug	Arm 2 High Risk
daunomycinTherapy 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	Drug	Arm 1 Standard Risk, Arm 2 High Risk
dexamethasoneTherapy 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	Drug	Arm 1 Standard Risk, Arm 2 High Risk
6-mercaptopurineTherapy 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	Drug	Arm 1 Standard Risk, Arm 2 High Risk
methotrexateTherapy 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	Drug	Arm 1 Standard Risk
6-thioguanineTherapy 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	Drug	Arm 2 High Risk
vincristineTherapy 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	Drug	Arm 1 Standard Risk, Arm 2 High Risk
Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)	Drug	Arm 1 Standard Risk, Arm 2 High Risk
Leucovorin	Drug	Arm 1 Standard Risk, Arm 2 High Risk

Primary outcome

Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years
Time frame: 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.

1 secondary outcome

To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis
Time frame: 5 years

Results and safety

Results posted to the registry on 9 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 Standard Risk	21	20
Arm 2 High Risk	39	34

Primary outcome: Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years

Time frame: 5 years. Number. Unit: percentage of participants

Measure	Arm 2 High Risk n = 37
Value	64.9

Population analysed: Number of high risk ALL patients treated.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 years, 6 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 Standard Risk	20 of 21 (95.2%)	21 of 21 (100%)	Not reported
Arm 2 High Risk	36 of 39 (92.3%)	39 of 39 (100%)	Not reported

Limitations and caveats (from the sponsor): Antifolate therapy was non-randomly assigned, therefore, we do not have a statistical basis to compare the toxicity observed among patients on the standard risk and high risk treatment arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barton Kamen, MD principal investigator

Rutgers, The State University of New Jersey

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aminopterin, L-asparaginase and cyclophosphamide in people with Acute Lymphocytic Leukemia, run by Rutgers, The State University of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00176462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.