RECENT CLINICAL TRIALS IN ACUTE LYMPHOCYTIC LEUKEMIA BY THE CANCER AND LEUKEMIA GROUP B

2000 ◽  
Vol 14 (6) ◽  
pp. 1367-1379 ◽  
Author(s):  
Richard A. Larson
Keyword(s):  
Clinical Trials ◽  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Group B ◽  
Leukemia Group

HOPES FOR TOMORROW VERSUS REALITIES OF TODAY: THERAPY AND PROGNOSIS IN ACUTE LYMPHOCYTIC LEUKEMIA OF CHILDHOOD

PEDIATRICS ◽  
1970 ◽  
Vol 45 (2) ◽  
pp. 191-193
Author(s):  
James F. Holland
Keyword(s):  
Acute Leukemia ◽  
Acute Lymphocytic Leukemia ◽  
Childhood Leukemia ◽  
Lymphocytic Leukemia ◽  
Current Therapy ◽  
Therapeutic Approaches ◽  
Institutional Level ◽  
Clinical Investigations ◽  
Group B ◽  
Leukemia Group

The inability of Drs. Stein, Ablin, Kushner and Zoger, in their Letter to the Editor1, to "see what good can come of exaggerating the effectiveness of current therapy" for childhood leukemia is not surprising. They imply that others have such distorted vision that they see castles where only hovels stand. The implication of Dr. Stein and his colleagues, were it true, would be damning. I believe that faulty logic, poor data, sketchy analysis, and embellished accounts in the popular press over which the interviewed exercises no editorial control led these correspondents to improper conclusions. In the design of clinical investigations to explore potentially improved therapeutic approaches to acute lymphocytic leukemia, the Acute Leukemia Group B has structured from two to five regimens into concurrent comparisons on a multi-institutional level.

The effects of postinduction intensification treatment with cytarabine and daunorubicin in adult acute lymphocytic leukemia: a prospective randomized clinical trial by Cancer and Leukemia Group B.

1991 ◽  
Vol 9 (11) ◽  
pp. 2002-2015 ◽  
Author(s):  
R R Ellison ◽  
R Mick ◽  
J Cuttner ◽  
C A Schiffer ◽  
R T Silver ◽  
...  
Keyword(s):  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Leukemic Cells ◽  
Prospective Randomized Clinical Trial ◽  
Cns Prophylaxis ◽  
Adult Acute Lymphocytic Leukemia ◽  
Receive Treatment ◽  
Group B ◽  
To Receive ◽  
Leukemia Group

Cancer and Leukemia Group B undertook a randomized trial of intensification treatment in adults aged 15 to 79 years with acute lymphocytic leukemia (ALL) in complete remission (CR). Daunorubicin (DNR), prednisone, vincristine (VCR), intrathecal (IT) methotrexate (MTX), and asparaginase produced 177 CRs in 277 patients. One hundred fifty-one patients were randomly assigned to receive treatment as follows: 74 received intensive cytarabine and DNR, and 77 received cycles of mercaptopurine (6-MP) and MTX, followed by 6MP, MTX, VCR, and prednisone for 3 years in all. One hundred twelve patients received CNS prophylaxis. Intensification produced major myelosuppression but did not improve remission duration (median, 21 months). Of the 151 patients with CRs who entered the intensification phase, 29% remain in continuous CR (43 to 117 months); in 19 patients, CRs have lasted for longer than 7 years. No relapses occurred after 60 months. Median survival from the time of randomization was 30 months. Those under 30 years of age responded more frequently, with longer CR and survival. While 53% of those aged 15 to 19 years remain in continuous CR, 92% of patients over 59 years have relapsed. The presence of a myeloid antigen on the leukemic cells was adversely prognostic for CR achievement and for survival. Pretreatment WBC and platelet levels independently affected CR duration and survival. Early M1 marrow development presaged longer remissions. CNS relapse occurred in 47 of 256 patients with normal CSF before treatment, in 29 before CNS prophylaxis. CNS disease occurred after CNS prophylaxis in 18 patients: 13 of 61 who had received standard premaintenance and five of 51 who received intensification. No advantage in CR duration or survival resulted from intensive treatment with DNR and cytarabine following induction of CR.

Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B

2006 ◽  
Vol 24 (28) ◽  
pp. 4553-4557 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler ◽  
Matthew Baker ◽  
Steven K. Cheng ◽  
Stephen L. George ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Activation Process ◽  
Oncology Group ◽  
Calendar Time ◽  
Phase Iii Clinical Trials ◽  
Decision Points ◽  
Phase Iii Study ◽  
Group B ◽  
Leukemia Group

Purpose National Cancer Institute–sponsored cooperative oncology groups are major sponsors of phase III clinical trials, yet the time and steps required to design and activate such studies has not been well studied. We examine the processes and document the calendar time required to activate such studies opened by the Cancer and Leukemia Group B (CALGB). Methods Setup steps were documented by (1) interviewing CALGB headquarters and statistical center staff and committee chairs to discover the steps required to transit from concept development to final study activation, (2) reviewing procedure manuals, and (3) inspecting all study records, documents, and e-mails to identify any additional steps. Calendar time was collected for each major process. Results Thirteen phase III studies were activated by CALGB during the study period of May 2002 to May 2005. More than 370 distinct processes were required for study activation: 317 work steps, 42 decision points, and 29 processing loops. Sixty-three percent of the decision points were outside CALGB. The complete process map measures 243.5” × 41” in 8-point font. Median calendar days to activate a phase III study at CALGB was 580 days (range, 295 to 1,248 days) from concept approval and 784 days (range, 537 to 1,130 days) from initial conception of the study. Conclusion Setup of a phase III study at a major cooperative oncology group is a complex and lengthy process, with the majority of decision points external to the cooperative group. To improve the activation process, research should to be directed toward both internal and external groups and processes.

Immunity to Diphtheria, Pertussis, Tetanus, and Poliomyelitis in Children with Acute Lymphocytic Leukemia After Cessation of Chemotherapy

PEDIATRICS ◽  
1981 ◽  
Vol 67 (2) ◽  
pp. 222-229 ◽  
Author(s):  
A. van der Does-van den Berg ◽  
J. Hermans ◽  
J. Nagel ◽  
G. van Steenis
Keyword(s):  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
First Year ◽  
Healthy Children ◽  
Healthy Control ◽  
Antibody Titers ◽  
Group A ◽  
One Year ◽  
Group B ◽  
Antibody Levels

Antibody titers to diphtheria, pertussis, tetanus, and poliomyelitis (types I to III) were measured in previously vaccinated children with acute lymphocytic leukemia in remission after cessation of therapy. The response to revaccination one year after therapy was stopped was also studied. The patients' antibody titers were compared with those of healthy children, matched for age and sex. Two groups of patients were studied: one group (group A, N = 30) was given two drugs (6-mercaptopurine, methotrexate); the other group (group B, N= 19) was given three drugs (6-mercaptopurine, methotrexate, and cyclophosphamide) for maintenance treatment. In general, the patients' antibody titers were lower than those of healthy children, but in most patients they were still at levels considered to be protective. No significant differences in antibody levels between the two patient groups were found. A spontaneous rise in antibody titers in the first year after termination of therapy was not observed. After revaccination the rise in antibody titers was correlated with preexisting antibody titers in the same way in patients as in healthy children, and the antibody titers in patients and in healthy control subjects were on roughly the same level.

Therapy-Related Myeloid Leukemias Are Observed in Patients With Chronic Lymphocytic Leukemia After Treatment With Fludarabine and Chlorambucil: Results of an Intergroup Study, Cancer and Leukemia Group B 9011

2002 ◽  
Vol 20 (18) ◽  
pp. 3878-3884 ◽  
Author(s):  
Vicki A. Morrison ◽  
Kanti R. Rai ◽  
Bercedis L. Peterson ◽  
Jonathan E. Kolitz ◽  
Laurence Elias ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Myeloid Leukemia ◽  
Lymphocytic Leukemia ◽  
Study Entry ◽  
Prolymphocytic Leukemia ◽  
Myeloid Leukemias ◽  
Purine Analog ◽  
Group B ◽  
Leukemia Group

PURPOSE: Patients with chronic lymphocytic leukemia (CLL) may have disease transformation to non-Hodgkin’s lymphoma or prolymphocytic leukemia; however, development of therapy-related acute myeloid leukemia (t-AML) is unusual. A series of patients enrolled onto an intergroup CLL trial were examined for this complication. PATIENTS AND METHODS: A total of 544 previously untreated B-cell CLL patients were enrolled onto a randomized intergroup study comparing treatment with chlorambucil, fludarabine, or fludarabine plus chlorambucil. Case report forms from 521 patients were reviewed for t-AML. RESULTS: With a median follow-up of 4.2 years, six patients (1.2%) to date have developed therapy-related myelodysplastic syndrome (t-MDS; n = 3), t-AML (n = 2), or t-MDS evolving to t-AML (n = 1), from 27 to 53 months (median, 34 months) after study entry. This included five (3.5%) of 142 patients treated with fludarabine plus chlorambucil and one (0.5%) of 188 receiving fludarabine; no chlorambucil-treated patients developed t-MDS or t-AML (P = .007). At study entry, the median age among these six patients was 56 years (range, 44 to 72 years); three were male; the CLL Rai stage was I/II (n = 4) or III/IV (n = 2). Response to CLL therapy was complete (n = 4) or partial remission (n = 1) and stable disease (n = 1). Marrow cytogenetics, obtained in three of six cases at diagnosis of t-MDS or t-AML, were complex, with abnormalities in either or both chromosomes 5 and 7. Other abnormalities involved chromosomes X, 1, 8, 12, 17, and 19. Median survival after diagnosis of t-MDS/AML was 3.5 months (range, 0.5 to 10.1 months). CONCLUSION: Our findings raise the possibility that alkylator-purine analog combination therapy may increase the risk of therapy-related myeloid malignancies, which is of particular relevance with regard to ongoing trials using these combination therapies.

Reducing patient eligibility criteria in cancer clinical trials.

1996 ◽  
Vol 14 (4) ◽  
pp. 1364-1370 ◽  
Author(s):  
S L George
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Eligibility Criterion ◽  
Cancer Clinical Trials ◽  
Recent Trial ◽  
Eligibility Criteria ◽  
Eligibility Requirements

PURPOSE To discuss patient eligibility criteria in phase III cancer clinical trials in the larger setting of the complexity of these trials, to review the various reasons for imposing restrictive eligibility requirements, to discuss the problems caused by these requirements, to argue that these requirements should be greatly relaxed in most cancer clinical trials, to provide some guiding principles and practical suggestions to facilitate such a relaxation, and to give an example of how eligibility requirements were reduced in a recent clinical trial in acute lymphocytic leukemia. METHODS Implicit and explicit reasons for including eligibility criteria in clinical trials are reviewed. Safety concerns and sample size issues receive special attention. The types of problems restrictive eligibility criteria cause with respect to scientific interpretation, medical applicability, complexity, costs, and patient accrual are described. RESULTS A list of three items that each eligibility criterion should meet in order to be included is proposed and applied to a recent trial in acute lymphocytic leukemia. CONCLUSION Phase III clinical trials in cancer should have much broader eligibility criteria than the traditionally restrictive criteria commonly used. Adoption of less restrictive eligibility criteria for most studies would allow broader generalizations, better mimic medical practice, reduce complexity and costs, and permit more rapid accrual without compromising patient safety or requiring major increases in sample size.

scholarly journals Participation in Cancer Pharmacogenomic Studies: A Study of 8456 Patients Registered to Clinical Trials in the Cancer and Leukemia Group B (Alliance)

2015 ◽  
Vol 107 (10) ◽  
pp. djv188 ◽  
Author(s):  
Lynn G. Dressler ◽  
Allison M. Deal ◽  
Kouros Owzar ◽  
Dorothy Watson ◽  
Katherine Donahue ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Group B ◽  
Leukemia Group ◽  
Pharmacogenomic Studies
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