Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00866307 |
| Other study ID # |
AALL08P1 |
| Secondary ID |
NCI-2009-01169CD |
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
February 23, 2009 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Children's Oncology Group |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This pilot clinical trial studies the side effects of pegaspargase when given together with
combination chemotherapy in treating patients with newly diagnosed high-risk acute
lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of
the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop
the growth of cancer cells, either by killing the cells, by stopping them from dividing, or
by stopping them from spreading. Giving more than one drug (combination chemotherapy)
together with pegaspargase may kill more cancer cells.
Description:
PRIMARY OBJECTIVES:
I. To demonstrate that biweekly intravenous (IV) pegaspargase beginning with Consolidation
and ending with completion of delayed intensification (DI) in combination with hemi-augmented
BFM therapy (hABFM) is feasible and safe in children with high risk (HR) acute lymphoblastic
leukemia (ALL).
OUTLINE: Patients are stratified according to risk assignment (high-risk [HR]-average [day 29
minimal residual disease (MRD) < 0.01%] vs HR-high [MRD >= 0.01%, presence of central nervous
system [CNS]3 leukemia, testicular disease, myeloid/mixed lineage leukemia [MLL]
rearrangement, hypodiploidy, or steroid therapy within the past month]). Patients are
assigned to 1 of 2 treatment groups.*
(Note: *Amendment 2 [4-22-2011] requires changes in the regimens. See the changes below,
after Maintenance therapy.)
INDUCTION THERAPY: All patients receive cytarabine intrathecally (IT) on day 1; vincristine
sulfate IV on days 1, 8, 15, and 22; prednisone IV or orally (PO) twice daily (BID) on days
1-28; daunorubicin hydrochloride IV over 15 minutes on days 1, 8, 15, and 22; methotrexate IT
on days 8 and 29*; and pegaspargase IV over 1-2 hours on day 4.
(Note: *Patients with CNS3 disease [white blood cells [(WBC)] >= 5/uL and positive for blasts
on cytospin] also receive methotrexate IT on days 15 and 22.)
CONSOLIDATION THERAPY (begins on day 36 of induction therapy):
GROUP A (HR-AVERAGE): Patients receive cyclophosphamide IV over 1 hour on days 1 and 29;
cytarabine IV over 15 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39;
mercaptopurine PO once daily (QD) on days 1-14 and 29-42; vincristine sulfate IV on days 15,
22, 43, and 50; methotrexate IT on days 1, 8, 15*, and 22*; and pegaspargase IV over 1-2
hours on days 15 and 43.
GROUP B (HR-HIGH): Patients receive cyclophosphamide, cytarabine, mercaptopurine, vincristine
sulfate, and methotrexate as in Group A. Beginning on day 1, patients also receive
pegaspargase IV over 1-2 hours every 2 weeks. Patients with CNS3 disease undergo cranial
radiotherapy QD for 10 days and patients with testicular disease undergo testicular
radiotherapy QD for 12 days, beginning on day 1 of consolidation.
(Note: *Patients with CNS3 disease [WBC >= 5/uL and positive for blasts on cytospin] do not
receive methotrexate IT on days 15 and 22.)
Interim maintenance (IM) therapy (begins on day 57 of consolidation):
GROUP A: Patients receive vincristine sulfate IV on days 1, 11, 21, 31, and 41; methotrexate
IV over 10-15 minutes on days 1, 11, 21, 31, and 41; methotrexate IT on days 1 and 31; and
pegaspargase IV over 1-2 hours on days 2 and 22.
GROUP B: Patients receive vincristine sulfate and methotrexate as in Group A. Beginning on
day 1, patients also receive pegaspargase IV over 1-2 hours every 2 weeks.
DI therapy (begins on day 57 of IM):
GROUP A: Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone
IV or PO BID on days 1-7 and 15-21; doxorubicin hydrochloride IV over 15 minutes on days 1,
8, and 15; cyclophosphamide IV over 1 hour on day 29; cytarabine IV over 15 minutes or SC on
days 29-32 and 36-39; thioguanine PO on days 29-42; methotrexate IT on days 1, 29, and 36;
and pegaspargase IV over 1-2 hours on days 4 and 43.
GROUP B: Patients receive vincristine sulfate, dexamethasone, doxorubicin hydrochloride,
cyclophosphamide, cytarabine, thioguanine, and methotrexate as in Group A. Beginning on day
1, patients also receive pegaspargase IV over 1-2 hours every 2 weeks.
MAINTENANCE THERAPY (MT; begins on day 57 of DI): All patients receive vincristine sulfate IV
on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO on
days 1-84; methotrexate IT on day 1; and methotrexate PO BID on days 8, 15, 22, 29*, 36, 43,
50, 57, 64, 71, and 78.
In both groups, MT repeats every 12 weeks until total duration of therapy is 2 years from the
start of IM for female patients and 3 years from the start of IM for male patients. Patients
in Group B who did not undergo radiotherapy to the brain during consolidation therapy undergo
prophylactic cranial radiotherapy (CR) daily for 8 days.
([Note: *Patients in Group A also receive methotrexate IT on day 29 of courses 1-4 [no oral
methotrexate]).
REVISED MT (RMT): The regimen is the same as standard MT, but 2 of the doses of IT
methotrexate are omitted (day 29 of courses 3 and 4).
