LeukemiaPhase 2NCT00022126
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
A Phase 2 study testing asparaginase, cyclophosphamide and cyclosporine in people with Leukemia, run by Children's Oncology Group at 51 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Leukemia
- What is being tested?
- asparaginase, cyclophosphamide and cyclosporine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 51 sitesin 3 countries
- Study dates
- Nov 2002to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
- CNS or testicular disease allowed
- No L3 sIg+ ALL or acute myelogenous leukemia
- At least 36 weeks gestation for congenital ALL
PATIENT CHARACTERISTICS:
Age:
- Under 366 days at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar puncture results known
- No chronic steroid treatment for other disease
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent cytotoxic therapy
Trial locations and contacts
51 sites in 3 countries.
51 sites in 3 countries
United States47 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0914
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
University of Chicago Cancer Research Center
Chicago, Illinois, 60601
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
Children's Medical Center - Dayton
Dayton, Ohio, 45404
Children's Hospital of Denver
Denver, Colorado, 80218-1088
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
Children's Mercy Hospital
Kansas City, Missouri, 64108
Loma Linda University Medical Center
Loma Linda, California, 92354
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Children's Hospital Central California
Madera, California, 93638-8762
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Mount Sinai School of Medicine
New York, New York, 10029
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Children's Hospital of Oakland
Oakland, California, 94609-1809
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Children's Hospitals and Clinics - Minnesota
Saint Paul, Minnesota, 55102
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Methodist Cancer Center
San Antonio, Texas, 78229-3902
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Deaconess Medical Center
Spokane, Washington, 99210-0248
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
CCOP - Scott and White Hospital
Temple, Texas, 76508
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19899
Australia2 sites
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Princess Margaret Hospital for Children
Perth, Western Australia, 6006
Canada2 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia.
- Determine the event-free survival of patients treated with this regimen.
- Determine the clinical prognostic features associated with outcome in these patients.
- Compare the biologic characteristics of the leukemia cells with outcome in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14; daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt CNS disease).
Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15.
Patients who do not receive bone marrow transplantation (BMT) proceed to interim maintenance #1 when blood counts recover. Patients receive methotrexate IT on days 1, 11, 22, and 32; methotrexate IV and vincristine IV on days 1, 11, 22, 32, and 43; and pegaspargase IM on days 2 and 23.
When blood counts recover, patients receive delayed intensification #1 comprising vincristine IV on days 1, 8, 15, 43, and 50; doxorubicin IV on days 1, 8, and 15; oral dexamethasone 3 times daily on days 1-7 and 15-21; pegaspargase IM on days 4 and 43; cyclophosphamide IV on day 29; methotrexate IT on days 29 and 36; oral thioguanine on days 29-42; and cytarabine IV or SC on days 30-33 and 37-40.
When blood counts recover, patients receive interim maintenance #2 comprising vincristine as in interim maintenance #1; methotrexate IT on day 1 and IV on days 1, 11, 22, 32, and 41; and pegaspargase IM on days 2 and 23.
When blood counts recover, patients receive delayed intensification #2 comprising vincristine, doxorubicin, dexamethasone, pegaspargase, cyclophosphamide, cytarabine, and thioguanine as in intensification #1. Patients also receive methotrexate IT on days 1 and 29.
When blood counts recover, patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; vincristine IV on days 1, 29, and 57; oral dexamethasone 3 times daily on days 1-5, 29-33, and 57-61; and oral mercaptopurine daily. Treatment repeats every 84 days for 6 courses.
Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance #1 and #2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification #1 and #2.
After augmented consolidation therapy, patients meeting the following criteria may receive BMT in place of chemotherapy:
- In remission
- Exhibiting chromosome translocation involving 11q23 or Ph+{(9;22)}
- Available HLA-A, B, DR genotypic identical relative donor
- No uncontrolled infection
- Adequate organ function Within 3-4 weeks of consolidation therapy, patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5; cyclophosphamide IV over 30 minutes on days -7 and -6; and methylprednisolone IV twice daily on days -2 to 0. Patients also undergo total body irradiation twice daily on days -3 to 0. Patients receive allogeneic BMT on day 0. Patients also receive cyclosporine IV every 12 hours beginning on day -1, switching to oral when possible, and continuing until day 60. Patients then taper cyclosporine over the next 60-120 days.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1-2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients will be accrued for this study within 2 years.
- Conditions
- Leukemia
- Being tested
- asparaginase, cyclophosphamide, cyclosporine, cytarabine, daunorubicin hydrochloride
- Keywords
- untreated childhood acute lymphoblastic leukemia, L1 childhood acute lymphoblastic leukemia, L2 childhood acute lymphoblastic leukemia, acute undifferentiated leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asparaginaseDrug
cyclophosphamideDrug
cyclosporineDrug
cytarabineDrug
daunorubicin hydrochlorideDrug
dexamethasoneDrug
mercaptopurineDrug
methotrexateDrug
pegaspargaseDrug
thioguanineDrug
allogeneic bone marrow transplantationProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Modified Augmented BFM Therapy | Experimental | Not described Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cyclosporine; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: methylprednisolone; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Procedure: allogeneic bone marrow transplantation; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group
Secondary outcomes (2)
Grade 3 or 4 non-hematologic toxicity rates
Event-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2002
- Primary completionJan 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul S. Gaynon, MD, Study chair, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022126
- Sponsor's protocol ID
- AALL01P1
- Other IDs
- COG-AALL01P1, CDR0000068787
- Status last verified
- Feb 2014
- First submitted
- 10 Aug 2001
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00022126
- Acronym / sponsor ID
- AALL01P1
- Conditions
- Leukemia
- Keywords
- untreated childhood acute lymphoblastic leukemia, L1 childhood acute lymphoblastic leukemia, L2 childhood acute lymphoblastic leukemia, acute undifferentiated leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia.
- Determine the event-free survival of patients treated with this regimen.
- Determine the clinical prognostic features associated with outcome in these patients.
- Compare the biologic characteristics of the leukemia cells with outcome in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14; daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt CNS disease).
Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15.
Patients who do not receive bone marrow transplantation (BMT) proceed to interim maintenance #1 when blood counts recover. Patients receive methotrexate IT on days 1, 11, 22, and 32; methotrexate IV and vincristine IV on days 1, 11, 22, 32, and 43; and pegaspargase IM on days 2 and 23.
When blood counts recover, patients receive delayed intensification #1 comprising vincristine IV on days 1, 8, 15, 43, and 50; doxorubicin IV on days 1, 8, and 15; oral dexamethasone 3 times daily on days 1-7 and 15-21; pegaspargase IM on days 4 and 43; cyclophosphamide IV on day 29; methotrexate IT on days 29 and 36; oral thioguanine on days 29-42; and cytarabine IV or SC on days 30-33 and 37-40.
When blood counts recover, patients receive interim maintenance #2 comprising vincristine as in interim maintenance #1; methotrexate IT on day 1 and IV on days 1, 11, 22, 32, and 41; and pegaspargase IM on days 2 and 23.
When blood counts recover, patients receive delayed intensification #2 comprising vincristine, doxorubicin, dexamethasone, pegaspargase, cyclophosphamide, cytarabine, and thioguanine as in intensification #1. Patients also receive methotrexate IT on days 1 and 29.
When blood counts recover, patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; vincristine IV on days 1, 29, and 57; oral dexamethasone 3 times daily on days 1-5, 29-33, and 57-61; and oral mercaptopurine daily. Treatment repeats every 84 days for 6 courses.
Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance #1 and #2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification #1 and #2.
After augmented consolidation therapy, patients meeting the following criteria may receive BMT in place of chemotherapy:
- In remission
- Exhibiting chromosome translocation involving 11q23 or Ph+{(9;22)}
- Available HLA-A, B, DR genotypic identical relative donor
- No uncontrolled infection
- Adequate organ function Within 3-4 weeks of consolidation therapy, patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5; cyclophosphamide IV over 30 minutes on days -7 and -6; and methylprednisolone IV twice daily on days -2 to 0. Patients also undergo total body irradiation twice daily on days -3 to 0. Patients receive allogeneic BMT on day 0. Patients also receive cyclosporine IV every 12 hours beginning on day -1, switching to oral when possible, and continuing until day 60. Patients then taper cyclosporine over the next 60-120 days.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1-2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Augmented BFM Therapy | Experimental | Drug: asparaginase, Drug: cyclophosphamide, Drug: cyclosporine, Drug: cytarabine, Drug: daunorubicin hydrochloride, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: mercaptopurine, Drug: methotrexate, Drug: methylprednisolone, Drug: pegaspargase, Drug: thioguanine, Drug: vincristine sulfate, Procedure: allogeneic bone marrow transplantation, Radiation: radiation therapy |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| asparaginase | Drug | Modified Augmented BFM Therapy |
| cyclophosphamide | Drug | Modified Augmented BFM Therapy |
| cyclosporine | Drug | Modified Augmented BFM Therapy |
| cytarabine | Drug | Modified Augmented BFM Therapy |
| daunorubicin hydrochloride | Drug | Modified Augmented BFM Therapy |
| dexamethasone | Drug | Modified Augmented BFM Therapy |
| doxorubicin hydrochloride | Drug | Modified Augmented BFM Therapy |
| mercaptopurine | Drug | Modified Augmented BFM Therapy |
| methotrexate | Drug | Modified Augmented BFM Therapy |
| methylprednisolone | Drug | Modified Augmented BFM Therapy |
| pegaspargase | Drug | Modified Augmented BFM Therapy |
| thioguanine | Drug | Modified Augmented BFM Therapy |
| vincristine sulfate | Drug | Modified Augmented BFM Therapy |
| allogeneic bone marrow transplantation | Procedure or surgery | Modified Augmented BFM Therapy |
| radiation therapy | Radiation | Modified Augmented BFM Therapy |
Primary outcome
Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group
2 secondary outcomes
Grade 3 or 4 non-hematologic toxicity rates
Event-free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
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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.
Paul S. Gaynon, MD study chair
Children's Hospital Los Angeles
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing asparaginase, cyclophosphamide and cyclosporine in people with Leukemia, run by Children's Oncology Group at 51 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Australia, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2014.