CCG 1961

Phase III Randomized Study of Treatment Based on Response to Induction Chemotherapy in Patients With Higher Risk Childhood Acute Lymphocytic Leukemia: Standard Versus Augmented Berlin-Frankfurt-Munster Regimen With Standard Versus Prolonged Intensification For Rapid Early Responders and Doxorubicin Versus Idarubicin and Cyclophosphamide With Delayed Intensification For Slow Early Responders

Note: this outline was patched together from the NCI online protocol and input from parents of kids with ALL. It is summarized here for our convenience, so that we can quickly compare our protocols. We do not guarantee the accuracy of this outline - it is not an official document. You can contact your child's oncologist and ask for the complete protocol document if you are interested in the details of your child's protocol.

CCG 1961 on the cancer.gov site.


(For abbreviations, see the bottom of this page.)

Treatment for high risk ALL, defined as presenting features of at least one of the following:

Note the following stipulations:

Protocol initiated, # patients: 10/96 (?), 1520 patients over 4 years

Specific Aims:

Also:

4 arms of treatment:

Patients on regimen C and D will also receive a new form of the drug L-asparaginase know as PEG asparaginase which permits a simpler treatment schedule.

SERs in remission on day 28 are randomized to 2 intensive treatments, one of which uses idarubicin instead of doxorubicin.

NOTE: delint = delayed intensification


CCG1961A

This treatment is considered "standard BFM for high-risk ALL"


CCG1961B

increased duration, standard intensity


CCG1961C


CCG1961D (RER)


CCG1961D (SER)

(note: another SER arm D substitutes idarubicin and uses it and cytoxin on a slightly different schedule)

(note: if PEG asp is not available, E asp can be substituted IM on a MWF schedule x 6 doses)


Notes:

Separates out RER from SER; SER have more intense regimen, similar to D but with 9 weeks consolidation and with radiation

C and D are more intense in that they use PEG asparaginase more often, methotrexate IV 5 times in interim maintenance instead of methotrexate PO, vincristine IV in interim maintenance

Skipping radiation for RERs who have no CNS involvement

Skipping mid week of dexamethasone to decrease aseptic bone necrosis noted on CCG 1882

No prior treatment for ALL is allowed on this trial.

 


Abbreviations:

WBC is white blood cell count. The WBC for a healthy child is 5,000-10,000/microliter

FAB is "French-American-British", a designation of the histology of the leukemic cell type. L1 and L2 are considered more favorable prognostically than L3.

CNS is central nervous system. The presence of leukemic cells in the central nervous system is monitored throughout the treatment.

RER Rapid early response. Day 7 marrow showing < 25% blasts (M1 or M2) defines rapid early responders (RER).

VPLD - vincristine-prednisone-L-asparaginase-daunorubicin treatment.

SER Slow early response, defined as > 25% marrow blasts (M3) at day 7.

delint Delayed intensification.

BFM (The Berlin-Frankfurt-Munster (BFM) 76/79 trial of acute lymphoblastic leukemia (ALL) in children produced impressive disease-free survival (DFS) rates with a protocol that began with 8 weeks of intensive therapy, followed by 8 weeks of maintenance therapy, and then another 6 weeks of intensive treatment)

M1, M2, M3 marrow:

M2 means the marrow has between 5% and 25% leukemic blasts.
M3 means there are more than 25% leukemic blasts.
M1 means less than 5% blasts and is the usual definition of a "remission"
marrow.

EFS Event free survival.

The following acronyms are used:

ARA-C Cytarabine, NSC-63878
ASP Asparaginase (E. coli), NSC-109229
CTX Cyclophosphamide, NSC-26271
DM Dexamethasone, NSC-34521
DNR Daunorubicin, NSC-82151
DOX Doxorubicin, NSC-123127
HC Hydrocortisone, NSC-10483
MP Mercaptopurine, NSC-755
MTX Methotrexate, NSC-740
PEG-ASP Pegaspargase, NSC-624239
PRED Prednisone, NSC-10023
TG Thioguanine, NSC-752
TIT Triple Intrathecal Therapy (IT MTX/IT ARA-C/IT HC)
VCR Vincristine, NSC-67574

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Last Updated 4/06

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